India Offers Guidance on Informed Consent Recordings, Formula for AE Compensation

Sponsors of clinical trials in India must inform enrollees dur-ing videotaped informed consent sessions about potential pay-ments resulting from adverse events, a draft guideline says.

The draft — published Jan. 15 by the Central Drugs Stan-dard Control Organization — is intended to help clinicians com-ply with a Nov. 21 order from the Ministry of Health and Family Welfare requiring the videotaping of informed consents (IMDRM, December 2013). It was accompanied by a formula to calculate the amount of compensation patients or families receive if a seri-ous adverse event or death occurs.

According to CDSCO, the consent process must include an explanation of the study’s purpose and general design, as well as a description of potential risks and expected benefits. If no clear benefit is anticipated, this must also be explained to participants.

Each video should show the investigator identifying and explaining the study protocol in a language the participant understands. The camera should capture facial details of the subject and investigator, while avoiding unrelated people, the guideline says.

A photo ID should be used to document the subject’s identity if the video is not adequate, the guideline adds. In cases where a participant is unable to give consent, due to a disability or impairment, a legal representative should be recorded during the consent process. The videotaped consent should be preserved for at least five years after the trial is completed or terminated.

CDSCO stresses that trial subjects are to receive free medi-cal care for the duration of the study. If a trial-related injury or death occurs, the sponsor, or whoever obtained permission from the licensing authority to conduct the trial, is required to provide financial compensation.

The agency released an interim formula for clinical trial investigators to use when calculating compensation requirements. The formula includes a base payout of about US $19,000, multi-plied by age and risk factors and divided by 99.37. Patients with a 90 percent expectancy of dying within 30 days would get about $4,800, CDSCO says.

India Offers Guidance on Informed Consent Recordings, Formula for AE Compensation ......... 1

Medtech Review Board Aims to Spur Production by Indian Devicemakers ..................... 2

Chinese Authorities Issue Fresh GMP Guidelines for Daily Site Inspectors ...................... 2

Russian Device Approvals Slow Dramatically In Absence of Guidance on New Regulations ....... 3

TGA OKs Summary Technical Reports As Evidence for Partial Joint Implants ................. 3

Perú Allows Imports of Unregistered Devices Under Certain Conditions ........................ 4

U.S. Final Rule Requires Pediatric Data in New Device Submissions ........................... 5

Modified 510(k) Devices Not Eligible For Custom Device Exemption: U.S. FDA ............ 7

Renal Denervation Safe, But Long-Term Benefits Unknown, Assessment Finds ................... 7

UK’s NICE Weighs In on Cardiac Therapies, Recommends Novel Migraine Treatment .............. 9

AdvaMed, TAMTA Partner to Spur Growth in Taiwan’s Device Market ....................... 9

In Brief ................................................................... 10

Editor’s Note: The International Medical Device Regulatory Monitor is available in an electronic edition, which includes web access to seven years of archived issues. For information on convert- ing to an electronic subscription, contact us at (888) 838-5578.

INTERNATIONAL MEDICAL DEVICE REGULATORY

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INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR February 2014Page 2

The compensation formula is based on recommen-dations in a 2013 parliamentary report on needed clini-cal trial oversight reforms (IMDRM, December 2013).

In comments to CDSCO, the Association of Clinical Research Organizations suggests the agency expand the language in the guideline to encompass “any device that can adequately capture the images and sounds required. ACRO notes that some research sites may use smart-phones or iPads to record consents, rather than a video camera, the device prescribed in the draft.

The group also recommends allowing sites that lack the infrastructure to store the recordings to employ a third party to do so — with the strict proviso that the content won’t be viewed.

ACRO spokesman John Lewis said the draft guide-line suggests “progress is being made” to raise the quality of clinical trial conduct in India, but noted the government has never clarified whether an earlier draft guideline on trial compensation was finalized (IMDRM, August 2013). “This is another example of the regulatory uncertainty that is crippling clinical research in India,” he said.

View the draft guideline at www.fdanews.com/ext/resources/files/02/02-14-IndiaConsent.pdf. The compen-sation formula is at www.fdanews.com/ext/resources/files/01/01-17-14-India.pdf. — Nick Otto

Medtech Review Board Aims to Spur Production by Indian Devicemakers

India’s Ministry of Health and Family Welfare said it will create a Medical Technology Assessment Board to evaluate existing and new technologies and accelerate production by local devicemakers.

The MTAB, recommended in the government’s cur-rent five-year plan, will function as part of the minis-try’s Department of Health Research and include econo-mists, social scientists, public health professionals and other specialists.

The aim is to “encourage the process and finalize the development of standardized cost-effective interven-tions,” reduce outlays on medical equipment and medi-cal costs, including out-of-pocket costs, and stream-line reimbursement processes, said Ghulam Nabi Azad, union minister for health and family welfare.

According to the five-year plan, the MTAB could spur growth in the domestic medtech industry. “But there is also need to set up strict regulatory … systems and mechanisms for quality control,” the plan says.

Operating in India can be frustrating for devicemak-ers due to the lack of a regulatory framework. The Drugs and Cosmetics (Amendments) Act, 2013, introduced in August, would have created a comprehensive regula-tory framework for devices in India (IMDRM, September 2013). But a parliamentary committee killed the bill in December, objecting to broader plans to create a Central Drugs Authority (IMDRM, January). — Nick Otto

Chinese Authorities Issue Fresh GMP Guidelines for Daily Site Inspectors

Chinese inspectors will focus their reviews on pro-duction technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections.

The areas of emphasis were spelled out in a guideline the China Food and Drug Administration released Jan. 13 advising daily site supervisors on inspection processes. It also advises inspectors to review current good manufac-turing practice guidelines when conducting inspections.

The guideline directs supervisors to submit on-site inspection materials, corporate corrective action plans and follow-up examination materials promptly to the relevant CFDA office. Open communication between corporate management and daily-site inspectors is

Document Index

The following documents covered in this issue of the Interna-tional Medical Device Regulatory Monitor are available for download at www.fdanews.com/IMDRMdocs.

CDSCO Guideline on Audio-Visual Consent

India’s Clinical Trial Compensation Formula

Peru’s Order on Importation of Unregistered Devices

U.S. FDA Final Rule on Pediatric Device Submissions

U.S. FDA Draft Guidance on Custom Device Exemptions

Eunethta Rapid Assessment of Renal Denervation

Summary of Comments on Eunethta Rapid Assessment

NICE Guidance on Implantable Cardioverter Defibrillators

Nice Guidance on Magnetic Migraine Device

COCIR Guideline on CT Energy Conservation

NICE Recommendation on Spinal Device

Ecuador’s Draft Regulation on External Limb Prostheses

INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITORFebruary 2014 Page 3

encouraged to ensure information is accurately dissemi-nated, when necessary.

Seth Goldenberg, a global medical research scien-tist at NAMSA, a regulatory and compliance research group, says the CFDA “released the guidance for the inspectors for industry to know what to expect when they show up. They still have to comply with the GMP, but it helps clarify the process.” – Nick Otto

Russian Device Approvals Slow Dramatically In Absence of Guidance on New Regulations

Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted.

While industry waits for the guidance, the registra-tion process has slowed dramatically, says Alexandra Tretiakova, executive director of the Russian Interna-tional Medical Device Manufacturers Association.

“The new system has not really made the registra-tion speedier, but oppositely, we heard a lot of com-plaints about long reviews, and delays from the regula-tory authority’s side,” Tretiakova says. Industry is also concerned about a lack of clarity regarding the require-ments from regulators and excessive requests from the Russian regulatory agency Roszdravnadzor.

The regulations created a 50-day timeline for reviews of device registration applications. But experts say confusion about the collection of fees — along with other issues such as an absence of class designations — is hampering efforts to get products to market more quickly (IMDRM, April 2013).

Under the old system, approvals took from four to six months, IMEDA says. Now they take a year or more.

According to Roszdravnadzor, just 1,250 new approval documents were processed last year —only 87 of which were completely new products. “We can say that for the moment, the approval process of medical devices in Russia is almost completely stuck,” Tretiakova says.

Another change brought about by the new regu-lations is that foreign manufacturers now must retain a local authorized representative to interact with the agency on their behalf.

One year later, it remains fuzzy what rights and responsibilities the local representatives have, but Tre-tiakova says the agency has made one thing clear: Local

representatives cannot validate submission files and their Russian translations on behalf of the actual manu-facturer. The actual manufacturer must validate all doc-umentation for submission.

“The only compromise that we found so far is the permission to the local authorized representative to per-form translation of the registration file without notary validation of the translated content,” Tretiakova says.

What Lies Ahead

Registration and regulation of medical devices remain high on Roszdravnadzor’s agenda this year, IMEDA says, along with renewed discussions of the Ministry of Health’s draft Federal Law on Medical Devices.

Other issues Tretiakova sees as priorities for indus-try and the agency include:

● Establishing a restrictive list and price controls for implantable devices;

● Potential trade protection by the Russian gov-ernment, to incentivize domestic businesses and preference their products in the government procurement system; and

● A value-added tax preference for newly regis-tered devices and those that undergo a certifi-cate exchange. This requires companies with existing certificates to replace them with certifi-cates designated by the new regulation.

On a side note, Tretiakova expressed hope that Rosz-dravnadzor’s recent foray into the International Medical Device Regulators Forum might “push the Russian gov-ernment to adopt at least some elements of the GHTF reg-ulatory concept, with less sample-testing in the premarket approval phase and more audits after approval.” The cur-rent regulations don’t require regulatory audits.

Roszdravnadzor became IMDRF’s eighth member in September (IMDRM, September 2013). IMDRF’s sin-gle-audit pilot program rolled out last month for audit-ing groups to join; it will open to devicemakers in June (IMDRM, November 2013). — Nick Otto

TGA OKs Summary Technical Reports As Evidence for Partial Joint Implants

Manufacturers of partial hip, knee and shoulder implants reclassified from Class IIb to Class III may use summary technical reports as interim evidence for inclu-sion of their devices in the Australian Register of Thera-peutic Goods, the Therapeutic Goods Administration says.

INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR February 2014Page 4

The TGA said the allowance was due to devicemak-ers’ difficulty in obtaining examination evidence from EU notified bodies by the transition deadline of July 1.

The agency emphasized, however, that the interim evidence allowance applies only to reclassification appli-cations received by TGA on or before June 30 for partial hip, knee and shoulder joint implants assessed by an EU notified body as Class IIb under Australia’s regulatory framework. Sponsors of devices accepted in the ARTG must provide an appropriate design examination applica-tion within 12 months of submitting the summary tech-nical reports.

The reports should clearly show that a notified body has assessed the device and include a positive rec-ommendation on the design examination provision or conformity assessment procedure. Companies should include a certificate specific to the full quality sys-tem for the specific type of device, in accordance with Directive 93/42/EEC, the TGA says.

Other documents normally required for Class III devices, such as notified body surveillance inspections and review of device design, should also be included with the reports, the agency says. Supplementary letters from the notified body confirming the above require-ments may be included if they are not fully noted in the technical report.

The TGA issued a regulation reclassifying hip, knee and shoulder joint implants in July 2012, following a lengthy consultation process fueled by global concerns about the safety of metal-on-metal hip replacements (IMDRM, August 2012). Since then, the agency has released several notices to help devicemakers transition to Class III, such as an updated list of permissible variant codes for product size and height (IMDRM, March 2013).

For additional support, devicemakers can contact devices@tga.gov.au. — Nick Otto

Perú Allows Imports of Unregistered Devices Under Certain Conditions

Peruvian officials have opened the door to the importation of unregistered devices for certain provi-sional uses.

According to new rules issued by the General Direc-torate of Medicines, Supplies and Drugs, unregistered devices will be allowed into the country for research projects, training and showroom purposes, and to meet requests for individual patient treatment.

Companies seeking to import an unregistered device must produce a marketing authorization or approval from a competent authority, or, in the case of research projects, documentation from the school or health organization requesting the device. Information about the device — e.g., name, make, model number, manufacturer and coun-try of origin — also should be provided.

DIGEMID will also permit the import of a device, prior to registration, for quality testing purposes at facil-ities approved by the National Center for Quality Con-trol and Laboratories. The rule spells out new provisions for device testing and points to general quality control guidelines already in place.

Part of the Trans-Pacific Partnership and the Pacific Alliance, Perú is Latin America’s second smallest medtech market. However, industry sources say it is projected to grow at an above-average rate over the next five years. Device regulations are strict, but no more so than in Colombia, Mexico or Brazil, they add. Last year, DIGEMID released a technical manual on good storage and distribution practices.

To market a device in Perú, manufacturers must obtain a sanitary registration. According to the Ministry

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of Health, 8,554 devices and drugs were registered in 2011, the last year for which data are available.

The order, published in the Official Journal on Dec. 24, is available in Spanish at www.fdanews.com/ext/resources/files/02/02-14-Peru.pdf. — Nick Otto

U.S. Final Rule Requires Pediatric Data in New Device Submissions

Devicemakers must include information on potential pediatric use in most new device submissions under a U.S. Food and Drug Administration final rule that takes effect April 10.

The rule is meant to comply with requirements in the FDA Amendments Act of 2007 and requires spon-sors’ submissions to include “a description of any pedi-atric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose or cure, and the number of affected pediatric patients,” if the information is “readily available.” The rule defines pediatric patients as anyone up to, and includ-ing, age 21.

Humanitarian device exemptions, premarket approval applications and product development proto-cols must all include the pediatric use information, the FDA says, adding that applications that don’t will not be approved. Sponsors of PMAs, HDEs and PDPs that are complete other than the pediatric data will receive “approvable” letters, while those with other problems will receive “major deficiency” or “not approvable” let-ters. The rule exempts 30-day PMA supplements.

Submissions for devices not indicated for pediat-ric use must submit the information “if [pediatric] uses are described or acknowledged in acceptable sources of readily available information,” the final rule says. This does not involve promoting off-label use because the rule doesn’t require applicants to perform clinical tri-als on pediatric patients — only to submit any studies already in existence on potential pediatric subpopula-tions, the agency says.

The agency declined to exempt devices that will never have pediatric uses, as requested by a stake-holder, saying future “modifications to a device … and advances in medicine could change whether a device could be used in a pediatric population.”

The Jan. 10 rule finalizes a draft that was issued almost a year ago. The draft replaced a 2010 version of the rule that was withdrawn after it was roundly criticized.

The FDA plans to publish guidance on what it con-siders “readily available information” and how to comply with the new requirements before the rule takes effect, agency spokeswoman Morgan Liscinsky said.

Separately, staffers in the agency’s Center for Devices and Radiological Health said they are working on ways to allow devicemakers to use more adult clini-cal trial data in proving the safety and effectiveness of pediatric devices.

Pediatric device development is often hamstrung by the limited pool of patients who can be recruited into clini-cal trials, as well as the special challenges posed by finding an appropriate control group and obtaining informed con-sent. As a result, children with orphan diseases are unable to receive new treatments that may be more effective.

Extrapolation of Adult Data

Laura Thompson, a CDRH statistician, said the cen-ter is now drafting a guidance document on the extrapo-lation of adult data for pediatric use of medical devices. The guidance will explain how manufacturers can use Bayesian statistical techniques to compensate for lim-ited pediatric trial data through such steps as includ-ing events that occurred before the pediatric study was launched. It will also describe how to determine if data gathered from adults is similar enough to data gathered from children for extrapolation to be appropriate.

“If the adult data is of higher similarity and quality, it’s more likely extrapolation will be appropriate for regulatory submissions,” Thompson said. She and other CDRH staff spoke at a public meeting on developing medical devices for pediatric patients afflicted by rare diseases.

When adapting devices for pediatric use, sponsors need to consider ways that children differ from adults, said Christy Foreman, director of CDRH’s Office of Device Evaluation. Pediatric device trials should take into account the physical growth of patients, possible hormonal changes and even patient activity level. Some devices have failed because children are so much more active than adults, she said.

Foreman recommended that trials be designed to treat the smallest and youngest patients possible, as a “worst-case scenario” for which safety should be proven.

Companies need to be aware that different FDA approval routes may involve different evidence require-ments, said John Laschinger, a medical officer in ODE.

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For example, sponsors seeking a PMA must demonstrate that the device is safe and effective, while applicants for humanitarian use devices must show the device is safe and possesses “probable benefits that outweigh the prob-able risks,” he said.

View the final rule at www.fdanews.com/ext/resour ces/files/01/01-13-14-Pediatric.pdf. — Elizabeth Orr

Modified 510(k) Devices Not Eligible For Custom Device Exemption: U.S. FDA

The U.S. Food and Drug Administration’s new cus-tom device exemption does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance.

However, if a manufacturer modifies a 510(k)-cleared device to treat a unique pathology or condition, making it unfeasible to study, it could qualify for the exemption, the agency says.

The custom device exemption — granted under the 2012 FDA Safety and Innovation Act — relieves qualifying devices from mandatory performance standards and pre-market approval requirements. The devices must be assem-bled or made on a case-by-case basis to meet the unique needs of a physician or dentist, or a patient suffering from a “sufficiently rare condition” that clinical trials of the device would be impracticable. Companies are limited to mak-ing five units a year of a particular custom device and must report those activities annually to the FDA.

Manufacturers of custom devices must still comply with the requirements for quality systems, design controls, medi-cal device reporting, corrections and removals, and registra-tion and listing. In addition to general labeling requirements, which apply to custom devices, labels should include:

● A statement that the device is a custom device; ● The names of the ordering physician or dentist

and patient, if applicable; ● Indications for use; ● Sterilization status; ● Relevant composition information, such as ma-

terials and components; and ● Storage conditions.

The annual reports submitted to the FDA should note the number of patients who received a new device or device revision during the year, and any patient who received multiple custom devices or components. They should also note the number of custom devices returned

by physicians or dentists because they did not meet a patient’s anatomical requirements.

If a manufacturer makes more than one device for a particular patient before it meets his or her anatomical requirements, the initial device(s) must be returned and destroyed so as not to count against the manufacturer’s five-unit total for the year, the draft guidance says.

A manufacturer’s initial report should include infor-mation regarding any custom devices provided between the enactment of FDASIA in July 2012 and the submis-sion of the first report. Subsequent reports will be due no later than March 31 of each calendar year.

While devicemakers aren’t required to begin submit-ting reports until the end of the calendar year that follows publication of the final guidance, the FDA encourages them to do so before then. The draft provides instructions on formatting and content of annual reports.

The draft also provides several examples of custom devices, including a hip replacement device for a patient with skeletal dysplasia and a unique anatomy that pre-vents the use of currently available implants.

While the FDA already clears and approves patient-specific devices, these typically have ranges of specifi-cations that were approved or cleared for patient popu-lations that can be clinically studied. These devices are sometimes called “customized,” but they are not custom devices, the guidance notes.

Devices being studied under, or considered for, an investigational device exemption are also not custom devices, which is a more limited exemption than an IDE, the FDA says. Devices that do not qualify as a custom device may still qualify for compassionate use.

Comments are due March 17 to docket no. FDA-2013-D-1601-0001. View the draft guidance at www.fdanews.com/ext/resources/files/01/01-13-14-custom.pdf. — April Hollis

Renal Denervation Safe, But Long-Term Benefits Unknown, Assessment Finds

The promising new hypertension treatment known as renal denervation is safe in the short to medium term, but more safety information is needed before conclusions can be drawn about its long-term benefits versus standard care in treating treatment-resistant hypertension. That’s the word following a rapid assessment by the European Network for Health Technology Assessment.

INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR February 2014Page 8

Eunethta conducted the pilot rapid assessment “to test the capacity of national HTA bodies to collabora-tively produce structured rapid core HTA information on novel medical technologies and to test the application of collaboratively produced HTAs in the national con-text,” a September project plan says. HTAs are used by government and private health insurers to decide which new technologies will be reimbursed.

A multistate team led by Katrine Frønsdal and Tove Ringerike of the Norwegian Knowledge Center for the Health Services reviewed data from 22 clinical trials and case studies totaling 904 patients. While most of the stud-ies involved Medtronic’s Symplicity catheter system, there was at least one study with each of the following: Medtron-ic’s Marinr RF catheter, BioSense Webster’s Navistar Ther-moCool, St. Jude Medical’s EnligHTN, Covidien’s One-Shot RDN and ReCor Medical’s Paradise technology.

Few Immediate Risks

Overall, the procedure was found to pose few imme-diate risks. But the lack of reporting on a number of endpoints kept the assessment team from fully endors-ing renal denervation. Several studies did not include a safety endpoint, and “adverse events were not ade-quately reported,” the assessment says.

The team also felt that the patient follow-up time was too limited to predict long-term effects, including any detrimental impact of renal denervation on the renal arteries. And they expressed a wish for more studies on systems other than Symplicity.

Procedure-related complications were reported in 13 of the 22 studies. While most were not serious, four studies did have major complications. These included four cases of renal artery dissection on placement of the catheter and one case each of psoas hematoma, respiratory depression and severe artery spasm. In addition, six studies reported major complications during the follow-up period, including hospitalization due to high or low blood pressure, angina, stroke or worsening of the existing renal condition. No deaths were reported during the follow-up period.

Industry feedback was solicited for the report. In response to a suggestion by Eucomed that experts in hypertension and renal denervation be part of the assessment team, Eunethta said future rapid assessments would include more clinical experts. The trade group also urged that “standard of care” and “conventional/tra-ditional” treatment be more clearly defined.

St. Jude, Boston Scientific, Medtronic and Covidien also provided comments for the report. View the rapid

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assessment at www.fdanews.com/ext/resources/files/01/01-06-14-rapidassessment.pdf. A summary of comments is available at www.fdanews.com/ext/resources/files/01/01-06-14-summary.pdf. — Elizabeth Orr

UK’s NICE Weighs In on Cardiac Therapies, Recommends Novel Migraine Treatment

The UK’s healthcare cost-benefit watchdog is recom-mending implantable cardioverter defibrillators as a first-line treatment for people with previous serious ventricular arrhythmia, those with a familial cardiac condition with a high risk of sudden death and patients who have under-gone surgical repair of congenital heart disease.

In draft guidance issued Jan. 20, the National Insti-tute for Health and Care Excellence says ICDs should be recommended as a “secondary prevention” for patients who, in the absence of a treatable cause, have:

● Survived a cardiac arrest due to either ventricu-lar tachycardia or ventricular fibrillation;

● Spontaneous sustained VT causing syncope or significant hemodynamic compromise; or

● Sustained VT without syncope or cardiac arrest, and who have an associated reduction in left-ventricular ejection fraction.

The assessment committee reviewed literature on 13 relevant randomized controlled trials of ICDs and found that implantation for the prevention of ventricular arrhythmia “decreased all-cause mortality and cardiac mortality in people with mild to moderate heart failure” and those with a prior history of heart attack.

Ventricular arrhythmias most commonly affect peo-ple with underlying heart disease and can occur with-out warning. Battery-powered ICDs check for irregular heartbeat and deliver a small electric shock to return the heart to its normal rhythm when required.

Anti-arrhythmic drugs are often not effective and can have unwanted side effects, said Carole Longson, NICE Health Technology Evaluation Centre director. “Implantable devices therefore represent an important option for both the treatment and prevention of poten-tially life-threatening arrhythmias and heart failure.”

Separately, NICE recommended the use of eNeura’s noninvasive transcranial magnetic stimulation device for the treatment and prevention of migraines. The company’s SpringTMS delivers a brief pulse of magnetic energy to the back of the head via a hand-held device to treat migraines.

In a multicenter randomized controlled trial, 39 percent of patients benefited from use of the device, getting a pain-free response within two hours. In another study, 98 percent of patients with medically resistant migraine who received repeated TMS reported a reduction in the frequency of head-aches at the end of one week — by as much as 50 percent.

The draft guidance emphasizes that clinical evidence on TMS is limited and the treatment is unlikely to benefit most of the six million people who suffer from acute and chronic migraine attacks. “Patients should be informed that TMS is not intended to provide a cure for migraine and that reduc-tion in symptoms may be modest,” the guidance says.

Current treatments for migraine include drugs such as painkillers, antiemetics and triptans, and some inva-sive treatments such as nerve blocks, botulinum toxin type A and acupuncture.

View the ICD guidance at www.fdanews.com/ext/resources/files/02/02-14-Cardiac.pdf. The guidance on TMS is at www.fdanews.com/ext/resources/files/02/02-14-Migraine.pdf. — Nick Otto

AdvaMed, TAMTA Partner to Spur Growth in Taiwan’s Device Market

U.S. and Taiwanese devicemakers have inked a memorandum of understanding aimed at supporting medtech innovation and advancing patient care.

Initial efforts between AdvaMed and the Taiwan Advanced Medical Technology Association include adopting a Taiwanese version of AdvaMed’s code of eth-ics and improving cooperation between U.S. and Tai-wanese regulators.

Elise Owen, associate vice president of global strategy and analysis, said one of the groups’ top pri-orities is reform of Taiwan’s healthcare payment sys-tem. While the country has universal healthcare cov-erage, often only the base model is reimbursed and not any of the “bells and whistles,” Owen told IMDRM. A patient undergoing cataract surgery may have the basic lens covered, but prescription contacts to avoid wearing glasses would not be reimbursed.

She contrasted that with U.S. reimbursement policy, which tends to support innovative, high-end products that significantly enhance a person’s quality of life or lead to better outcomes. Taiwan’s system is “very, very, tight and very, very restrictive,” she said.

To make matters worse, the Taiwanese government is considering capping the amount people can pay above

INTERNATIONAL MEdIcAL dEvIcE REGULATORY MONITOR February 2014Page 10

and beyond the base rate for healthcare products, Owen said. If the basic product costs $100 and an upgraded version sells for $200, the government may say, “No, the most you can ever pay is $150, even if it’s coming out of your own pocket,” she explained. Such restrictions are “really troubling” and could significantly limit market opportunities for innovative products coming into Tai-wan, Owen said.

Another issue the groups hope to influence is the Trade and Investment Framework Agreement, an over-arching trade negotiation between Taiwan and the U.S. Talks on TIFA resumed last year. — Nick Otto

IMDRF to Host Public WorkshopThe International Medical Device Regulators

Forum will hold a one-day open session on March 26 in San Francisco to get stakeholder feedback on prod-uct safety, harmonization and emerging issues. There is no fee to participate, but early registration is recom-mended. For additional information, visit www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConfer ences/ucm378544.htm.

Energy-Saving Tips for CT Scanners European trade group COCIR has issued a volun-

tary guideline on ways to reduce energy consumption with CT scanners. The group notes that heat dissipa-tion and air-cooling systems are the main consumers of energy with CT devices and suggests users rou-tinely consult with manufacturers to ensure the device is “configured for optimal performance and minimum energy consumption according to real-use scenarios.” Proper maintenance should also be performed by a qualified person. View the voluntary guideline at www.fdanews.com/ext/resources/files/02/02-14-CO CIR.pdf.

NICE Recommends Scoliosis Device The UK’s National Institute for Health and Care

Excellence is recommending use of Ellipse Technolo-gies’ MAGEC system for the treatment of early onset scoliosis in children 2 to 11 years old. The novel system consists of extendable titanium rods that are attached to the ribs or spine near the curved section of the spine similar to the way that conventional rods are implanted. A remote device controls magnets in the rod to adjust the length, sparing the child repeated surgeries to lengthen the rods. MAGEC received a CE mark in Octo-ber 2009 for use as a spinal bracing and distraction sys-tem implant. View the draft guidance at www.fdanews.com/ext/resources/files/02/02-14-NICEspine.pdf.

Ecuador Sets Rules for External ProsthesesEcuador’s Ministry of Industry and Productivity

is seeking input on a draft technical regulation estab-lishing requirements for external limb prostheses and orthoses. The proposal, which applies to domestic and imported products, covers classification, product and labeling requirements, conformity assessment tests, sampling, regulatory documents serving as references, monitoring and inspection, noncompliance penalties, and review and updating. Comments are due March 18. The proposed effective date is Sept. 18. View the draft regulation at www.fdanews.com/ext/resources/files/02/02-14-ecuador.pdf.

EC Opens Consultation on EMF Health EffectsThe European Commission is seeking input through

April 16 on a preliminary opinion on potential health effects of electromagnetic fields, noting MRI scan-ners and active implanted devices are hotspots for EMF exposure. A March 27 workshop will address scien-tific evidence and knowledge gaps. View the opinion, visit www.fdanews.com/ext/resources/files/02/02-14-SCENIHR.pdf. To register for the workshop, visit www.eeae.gr/gr/html/files/_emf_workshop.html.

Reporters: Elizabeth Orr, Ferdous Al-Faruque, Lena Freund, Robert King, Melissa Winn

President: Cynthia Carter; Content Director: Dan Landrigan; Executive Editor: Meg Bryant

Copyright © 2014 by Washington Business Information Inc. All rights reserved. International Medical Device Regulatory Monitor (ISSN 1079-6940) is published monthly, 12 issues, for $799. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permis-sion. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400.

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Bring the same training used by FDA inspectors right to your conference room. Make the commitment! Order Secrets of QSIT-Based Medical DeviceInspection Preparation today.

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Medical Device Complaint Management

Building a Robust System to Meet Global Requirements

Visit www.FDAnews.com/mdcomplaintmngmt or call (888) 838-5578

March 11–12, 2014 • Westin Waltham-Boston Hotel • Waltham, MA (Boston)

Dan O'Leary, Ombu Enterprises LLC

Dan O’Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

You start with a hypothetical complaint, then trace it through the regulatory system. First come lectures, then interactive exercises — 11 of them over two days. You find yourself out of your chair and engaging with devicemakers like yourself — from the EU, Canada and all across the US — confronting and solving shared problems.

At the conclusion of each small-group exercise, you take a test. But not to worry —you can’t fail. Answers will be provided, plus proven solutions to take home and apply in your operation. We know of no other workshop providing such fine-grained level of interactivity, not to mention solutions you can put into effect — at once.

Attendees to this all-new workshop will learn:

An Interactive Workshop Featuring 11 Hands on ExercisesPresented by Ombu Enterprises and FDAnews

•The role of Unique Device Identification (UDI) in complaints and adverse event reporting

•Regulatory reporting requirements in three major markets: US, EU, and Canada•Understanding why the source of a complaint (Facebook, Twitter, email, phone

call) is not your chief concern — it’s how to handle the communication•The proper use of corrective action in complaint management, including statistical

analysis•Developing a complaint classification system that links to the risk management file•Analysis methods to help determine the impact of design changes on regulatory

requirements•Planning field actions and making regulatory reports

Visit www.FDAnews.com/mdcomplaintmngmt or call (888) 838-5578

DAY ONe: TUesDAY, MARCH 11

8:00 a.m. – 9:00 a.m. rEgIstrAtIOn AnD COntInEntAL brEAKfAst

9:00 a.m. – 10:15 a.m. Part A – the Intersection of Com-plaints and the regulatory structure• Understanding the Quality Management System (QMS) in the US, EU and Canada• Distinguishing records and reports to regulatory agencies (content, trigger, and timing)• How and why the FDA conducts inspec-tions and the guiding documents they use

o Quality System Inspection Technique o Compliance Program 7382.845

Inspection of Medical Device Manufacturers

• Using sampling plans as part of the Medical Device Directive (MDD) audit

Exercise – fDA Inspection Levels

Exercise – QsIt sampling plans for records

10:15 a.m. – 10:30 a.m. brEAK

10:30 a.m. – 12:00 p.m. Part b – how newly Enacted unique Device Identification Will Impact Complaints• Overview of the US regulations regarding UDI• What are Device Identifiers and Produc-tion Identifiers — and how do they differ?• Understanding the GUDID and the information you need to supply

Exercise – Creating a new Device Identifier

Part C – servicing: the front Line for Complaints?• Definition of servicing — is your definition and regulators’ the same? • How servicing relates to other QMS elements• Producing service records and linking them to complaints

• Tips, tools and techniques for analyz-ing service records; what should you be looking for?

Exercise – Analyze a small set of service records using quality tools

12:00 p.m. – 1:00 p.m. LunCh brEAK

1:00 p.m. – 2:30 p.m. Part D – Complaints• Definition of a complaint — distinguish-ing regulatory complaints from customer service complaints• Comparing and contrasting QSR vs. ISO 13485 definitions• Successfully developing and managing complaint classification systems• Fully understanding complaint system interrelationships; it’s harder than it appears

o Complaints and corrective action o Complaints and MDRs o Complaints and EU Vigilance o Complaints and risk management

(ISO 14971)• Complaint system flowchart• Determining the required content for complaint records

Exercise – Analyze customer reports to determine if they are a complaint and potentially reportable

2:30 p.m. – 2:45 p.m. brEAK

2:45 p.m. – 4:30 p.m. Part E – medical Device reports (us)• Understanding the criteria for reporting• Establishing the MDR event files that serve their purpose and stand up to FDA scrutiny• Identifying Designated Individuals• MDR system interrelationships• Examining the nexus between MDRs and complaints• Getting to know the types of MDRs (30-day and 5-day)• Reporting MDRs — proven strategies that work for all companies• Records required for the MDR system — what you must have

Exercise – Initiate a medical Device report

Part f – medical Device reports in the Eu and Canada• Understanding the criteria for reporting• The regulatory structure in the EU (MDD and MedDev)• The regulatory structure in Canada• Role of the Notified Body in the Vigilance System• Role of the MDD Authorized Represen-tative in the Vigilance System

Exercise – Analyze an adverse event to determine when to report

4:30 p.m. sEssIOn WrAP-uP, EnD Of DAy OnE

DAY TWO: WeDNesDAY, MARCH 12

8:30 a.m. – 9:00 a.m. COntInEntAL brEAKfAst

9:00 a.m. – 10:15 a.m. Part g – Corrective Action and Preventive Action (CA&PA)• The difference between corrective action (CA) and preventive action (PA)• Understanding CA&PA interrelation-ships in the QMS• The CA&PA flowchart —implementing it in your QMS

o CAPA verification and validation o CAPA effectiveness review o CAPA records — opening, closing

and managing the records effectively• Tips, tools and techniques for complaint analysis; what should you be looking for?

Exercise – Analyze complaints as quality data to identify quality problems

10:15 a.m. – 10:30 a.m. brEAK

10:30 a.m. – 12:00 p.m. Part h – Design Changes• Understand the role of change in the design control system• Design change interrelationships — the four important considerations

o When a production change is a design change

o Does the design change create a new Device Identifier?

o Does the design change require an updated 510(k)?

MEDICAl DEvICE COMPlAInt MAnAgEMEnt march 11–12, 2014 • Westin Waltham-Boston hotel • Waltham, ma

“I thought the presenter was thorough and provided real-world examples in order to enhance the presentation.”

Isabel Hoverman, Quality Engineer, Orthofix, Inc.

o Does the design change impact the Risk Management File?

• The design change flow chart shows the picture• Design change records —tips for main-taining the Design History File (DHF)

Exercise – Classify changes as a de-sign change or a production process change

12:00 p.m. – 1:00 p.m. LunCh brEAK

1:00 p.m. – 2:30 p.m. Part I – 510(k) Changes• When a design change requires a pre-market notification change• 510(k) change process interrelationships• 510(k) change records and reports• FDA’s 1997 guidance document — 17 years old, but still applicable today• The 2012 law and FDA’s plan — what’s the latest and what’s on the horizon

Exercise – Analyze design changes to determine if they require a revised 510(k)

2:30 p.m. – 2:45 p.m. brEAK

2:45 p.m. – 4:30 p.m. Part J – Corrections and removals (C&r)• Defining the terms — a source of constant confusion• Understanding how the C&R regulations relate to the QMS• Distinguishing enhancements from recalls — the FDA guidance and its theory

• C&R records and reports — distinguish-ing between the requirements• Overview of the integrated system and how to make it work for you• Bringing all the pieces together — best practices for building C&R procedures that work

Exercise – Evaluate proposed field actions to determine if they are a correction or a removal

4:30 p.m. ADJOurn WOrKshOP

Visit www.FDAnews.com/mdcomplaintmngmt or call (888) 838-5578

MEDICAl DEvICE COMPlAInt MAnAgEMEnt march 11–12, 2014 • Westin Waltham-Boston hotel • Waltham, ma

11 COmPrEhEnsIVE ExErCIsEs yOu CAn’t AffOrD tO mIss!

“[Dan] has a great approach to teaching a group of professionals with very different backgrounds and experience.”

Walter Domozych, Principle Quality Engineer, Boston Scientific

Your mentor is Dan O’Leary, a 30-year veteran of device quality compliance and five-star presenter. Mr. O’Leary is a master at working with devicemakers large and small to apply proven methods that build end-to-end complaint management systems. Register today to take advantage of these exclusive interactive exercises.

1. FDA Inspection Level — FDA investigators plan the extent of their inspections based on the levels in the Program Compliance Guide. This exercise provides participants an opportunity to apply these ideas and understand the factors that determine the depth of the inspection.

2. QSIT Sampling Plans for Records — When an FDA investigator asks for records, the number reviewed is determined by a sampling plan in QSIT. This exercise explains how the investigator classifies the records and estimates the error rate. It is not Z1.4 acceptance sampling.

3. Creating a New Device Identifier — The UDI regulations require manufacturers to create Device Identifiers (DI) for each version or model as well as Device Identifiers for each packing level. They must be included in the complaint records, Medical Device Reports, and Correction & Removal files. This exercise helps participants understand when a change creates a new Device Identifier (DI).

4. Analyze a Small Set of Service Records Using Quality Tools — 820.200 requires manufacturers to analyze service records using statistical techniques applicable for data analysis in 820.100. In some cases, servicing, complaints and MDRs are tightly coupled. This exercise introduces a small data set and gives participants an opportunity to apply techniques.

Visit www.FDAnews.com/mdcomplaintmngmt or call (888) 838-5578

MEDICAl DEvICE COMPlAInt MAnAgEMEnt march 11–12, 2014 • Westin Waltham-Boston hotel • Waltham, ma

“[Dan is an] Excellent speaker. Great experience and examples. Interactive discussions in particular were very helpful.”

Brian Ray, Senior Manager Risk Management, Welch Allyn

“It was a very methodical approach, enjoyed the examples.”

Randall Lenz, CQT Consultant/QE, Stryker Instruments

“The examples given were helpful, and the presentation was very easy to follow.”

Karyn Schwitters, Regulatory Affairs Specialist, Anderson Packaging, Inc.

5. Analyze Customer Reports to Determine If They Are a Complaint and Potentially Reportable — The definition of complaint in medical device regulations is technical, and requires analysis to determine when a report alleges a “regulatory complaint”. In addition, complaints must be evaluated to determine which ones could lead to a Medical Device Report. This exercise provides examples that help participants distinguish among the various cases.

6. Initiate a Medical Device Report — In the US, some complaints are reported to the FDA as a Medical Device Report. This exercise uses an example problem and offers participants an opportunity to see how the information relates to the fields in the MDR form.

7. Analyze an Adverse Event to Determine When to Report — In the EU, some are reported using the Manufacturer’s Incident Report form from MEDDEV 12.2-1 on the Vigilance System. This exercise uses an example problem and offers participants an opportunity to see how the information relates to the fields in the MDR form.

8. Analyze Complaints as Quality Data to Identify Quality Problems — Medical device manufacturers expect to receive complaints at some rate. The manufacturer must track the rate for different kinds of complaints, for risk management post-market surveillance and for EU vigilance reporting. This exercise provides an opportunity for participants to determine a baseline rate, a trigger point, and determine if the rate is still acceptable.

9. Classify Changes as a Design Change or a Production Process Change — QSIT informs the FDA investigator that Production and Process Changes could be Design Changes. This exercise provides participants an opportunity to classify changes and provides insight into the decisions to make in the QMS.

10. Analyze Design Changes to Determine If They Require a 510(K) — Every design change for a 510(k) device must be evaluated to determine if it is significant enough to update the 510(k). This exercise provides some situations for participants to analyze.

11. Evaluate Proposed Field Actions to Determine If They Are a Correction or a Removal — Whenever a manufacturer changes a product in the field, there must be an evaluation to determine if the change is a correction or a removal. In addition, there must be an evaluation of reportablility. This exercise provides practice in making those evaluations.

testimonials from Past attendees

© Copyright 2014 by FDAnews

Medical Device Complaint Management WorkshopMarch 11–12, 2014 • Westin Waltham-Boston Hotel • Waltham, MA

• Quality Managers

• Regulatory Affairs Managers

• Engineering Managers

• Quality Engineers

• Design Engineers

• Project Managers involved in design and development

• Specialists assigned to complaints, corrective actions or medical device reporting

• Recall coordinators

• Medical staff evaluating risk, safety or effectiveness

• General/corporate counsel

• Full slides from the PowerPoint presentations

• Copies of each interactive exercise worksheet as well as an answer key for each exercise

• A copy of an Excel worksheet that helps analyze the FDA regulations. It has a series of questions that start with a complaint and follow the reporting and record-keeping decisions to help understand the integrated requirements spread across different parts of the regulations.

• Reference documents: o FDA draft guidance on Medical Device Reporting

o FDA draft guidance on Corrections and Removals

o FDA guidance document on 510(k) changes

o MEDDEV document an the Vigilance System

o Health Canada document on Medical Device Problem Reporting

Dan O’LearyDan O’Leary is President of Ombu Enterprises, LLC, an education, training and consulting company focusing on Operational Excellence using analytical skills and a systems approach to operations management. Dan has more than 30 year’s experience in quality, operations and program management in regulated industries, including aviation, defense, medical devices, and clinical labs. He holds a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Ombu Enterprises, LLCOmbu works with manufacturing companies, offering training and execution in operational excellence. Focusing on the analytic skills and systems approach of operations management, Ombu helps companies achieve efficient, effective process and regulatory compliance.

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Medical Device Complaint Management WorkshopMarch 11–12, 2014 • Westin Waltham-Boston Hotel • Waltham, MA