A SEMINAR ON

MEDICAL DEVICE REGULATION

Vikash Kumar Vyas L.J Institute of pharmacy, Ahmedabad

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CONTENT DEFINITION

MEDICAL DEVICE AS PER USA

MEDICAL DEVICE AS PER CDSCO

GTU QUESTIONS

REFERENCES

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DEFINITION

Medical device is instrument, apparatus, implant other similar or related article, which is intended for use in diagnosis, disease, cure, mitigation, prevention or treatment of disease or intended to affect the structure or any function of the body and which does not achieve its primary intended purposes through its chemical action within or on the body.

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MEDICAL DEVICE AS PER USFDA

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Medical device define as per section 201 of thefood, drug and cosmetic act, An instrument, apparatus, implement, machine, contrivance,

implant, in vitro reagent, or other similar or related articles, including any component, part, or accessory, which is:

Recognized by the official National Formulary, or the United States Pharmacopoeia (USP), or any supplement to them.

Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation treatment, or prevention of disease, in a man or other animals.

Intended to affect the structure or any function of the body of a man or other animals, and which does not achieve any of its principal intended purposes through chemical action within or on the body of a man or other animals and which is not dependent upon being metabolized for the achievement of its principal intended uses."

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Medical device classification

Class I low risk

Class II medium risk

Class III high risk

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Class IClass I medical device having low risk and simple indesign. Which exempted from 510(k):

Tongue depressor Elastic bandage Hand held dental instrument Examination gloves

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Class IIClass II Medical devices are more complicated in design and poseminimal risk must submit 510(k)

X-ray machine powered wheelchairs infusion pump surgical and

acupuncture needles

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Class IIIClass III Medical Devices are intricate in design and have the strictestguidelines because they pose the greatest risk. Class III Medical devicemust follow class I and class II guidelines and require PMA (pre marketapproval) before marketing

implanted pacemakers heart valves • implanted cerebral simulators.

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Flow chart market authorization process USA

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Premarket notification 510(k)The faster marketing process is premarket notification or 510(k).the 510(k)applicantmust demonstrate to FDA that their device is substantially equivalent to a legallymarketed device that is one that was marketed before May 28, 1976 or one that wasmarketed after that date that was found substantially equivalent through the 510(k)process.

WHAT IS SUBSTANTIAL EQUIVALENT?Substantial equivalence means that the new device is at least as safe and effective asthe predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and has the same technological characteristics as the predicate

Substantial equivalence is established with respect to intended use, design, energy usedor delivered, materials, chemical composition, manufacturing process, performance,safety, effectiveness, labeling, biocompatibility, standards, as applicable. 

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Types of 510(k)Special 510(k): Limited to certain circumstances and must contain a “Declaration of

Conformity” with design control requirements FDA intends to process special 510(k)s within 30 days of DCO receipt

Abbreviated 510(k) : Guidance document exist A special control has been established FDA has recognized a relevant consensus standard

Traditional 510(k): No specific 510(k) form but there is an FDA suggested format

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Who is required to submit 510(k)1. Domestic manufacturers introducing a device to the U.S. market

2. Specification developers introducing a device to the U.S. market

3. Repackers or relabelers who make labeling changes or whose operations significantly affect the device

4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

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When 510(k) is not required

You sell unfinished devices to another firm for further processing. Your device is not being marketed or commercially distributed. You distribute another firm's domestically manufactured device. If you are a re-packager or a re-labeler you are not required to

submit a 510(k) if the existing labeling or condition of the device is not significantly changed.

Your device was legally in commercial distribution before May 28, 1976 and you have documentation to prove this.

The device is made outside the U.S. and you are an importer of the foreign made medical device.

Your device is exempted from 510(k) by regulation

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Components of 510(k)1. The cover sheet (FDA form 3514):This five pages provides the

ODE(Office of Device Evaluation) with general information related to the submission in a standardized format.

2. The cover letter: Should not be more than 1 or 2 pages long and identify the device, content of application briefly, provide the name, address, telephone, the type of 510(k) should be specified.

3. Table of contents: This section helps to create a “reviewer friendly” document by making it easy for the reviewer to locate each key section.

4. User fee information: The unique payment identification number present in this form enables the ODE to confirm that the user fee payment has been received.

5. Statement of substantial equivalence: This optional section can “sell” the 510(k) to the ODE by providing a well reasoned rationale for a substantial equivalence determination.

6. Labeling: This section must provide the ODE with all printed material associated with the device.

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7. Advertising or promotional material: This is optional. If provided ODE will review the documentation and inform the sponsor of area noncompliance.

8. Comparative information: This section must be contain data that demonstrate that the 510(k) device is “substantially equivalent” to the predicted device(s).

9. Biocompatibility assessment: The data in this section must demonstrate that the device materials do not cause toxicity.

10. Truthful and accurate statement: This statement identifies a person who takes legal responsibility for the accuracy of the 510(k).

11. Clinical data: ODE may request clinical data to demonstrate substantial equivalence to a predicted device.

12. Shelf life indication for use form: stability of device components and packaging integrity (for sterile device) must be demonstrated.

13. Indication for use form: This form clarifies, for any interested party, the device’s cleared indication(s) for use.

14. 510(k) summary: They provide interested parties with a brief description of the device and some of the data included in the 510(k).

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510(k) submission process

ODE and OIVD( Office of In Vitro Diagnostics) are responsible for the processing and review of 510[k] for marketing clearance.

510(k) submissions are date stamped and logged into the DMC(data monitoring committee) computer database where a unique control number is assigned to the document.

If the person who intends to market the device uses a consultant or another party to prepare the 510(k), the 510(k) submission should specify who the 510(k) owner is and who the preparer is.

The DMC database program will first check the system to ensure user fees have been received.

Next, the DMC database program will assign the 510(k) a due date and sequential position in the queue based on the receipt stamp date.

The database program will generate an "acknowledgment letter" with the assigned 510(k) number.

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The 510(k) is sent to the appropriate ODE or OIVD reviewing division for the type of device.

Upon receipt in the Division, the reviewer utilizes the Pre-Review Form: Company/Device History form as an initial screening tool.

The submitter will not receive an acceptance letter when a file is determined to be administratively incomplete.

If the 510(k) is administratively incomplete, a recommendation to issue a "Refuse to Accept" letter will be forwarded to the division supervisor for concurrence.

The 510(k)s are reviewed, in order, according to the original or additional information receipt date assigned by the Document Mail Center.

FDA Requests for Additional Information. Decision Letter Issued. Submitters may request information on their 510(k) review status 90 days

after the initial log-in date of the 510(k). Fill status report form FDA 3541 and fax it to CDRH.

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510(k) review fee

The Fees for Fiscal Year 2015 (October 1, 2014 through September 30, 2015)are as follows:

Submission Standard fees Small business fees

510(k) $5,018 $2,509513(g) $3,387 $3,387

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Pre market approval(PMA) A PMA is the assessment process of FDA for the safety and effectiveness

of most Class III medical devices. Because of the high risks associated with these devices, FDA has determined that special controls (as described for 510(k) approval) alone are not sufficient to guarantee safety and effectiveness of the product. Therefore, a PMA is required for these devices.

The PMA documentation, that has to be submitted by the manufacturer, includes both administrative elements and scientific evidence sections. Although the scientific part is the main part of the document, an application will not be assessed if the document lacks certain administrative elements. If certain clinical data or scientific arguments are lacking, the assessment process will be delayed. It is therefore recommended to manufacturers to have their applications reviewed before submission to FDA.

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There are two scientific evidence sections in a PMA application:

Non-clinical research: This section contains information on, among others, the microbiology, toxicology, immunology, biocompatibility, wear and shelf life of the product. Non-clinical research has to be performed in accordance with certain regulations, defined in 21 CFR Part 58.

Clinical research: This section has to contain at least study protocols, safety and effectiveness data, adverse reactions and complications, patient information and results.

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PMA component1. Cover page: This five pages provides the general information related to

the submission in a standardized format.2. Table of contents: This section helps to create a “reviewer friendly”

document by making it easy for the reviewer to locate each key section3. Summary of safety and effectiveness: This section provide information

about clinical trial generated data about safety and effectiveness.4. Device description and manufacturing data: Gives information about

manufacturing date, licence number, name of manufacturer brief description about device.

5. Performance standards referenced: This document provides instructions for calculating the control performance of the balancing authority (BA) and instructions and forms to complete the required surveys.

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6. Technical data (nonclinical and clinical): Gives information about animal study and human study.

7. Justification for a single investigator: provide and justify all requested costs associated with the proposed project.

8. Bibliography: It indicate references.

9. Device sample (if requested): Sample of device if requested

10. Labeling: This section must provide the ODE with all printed material associated with the device.

11. Environmental assessment: this section provide information that study is harmful for environment or not.

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MEDICAL DEVICE AS PER CDSCO

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Medical device regulation in India In India medical devices are governed by CDSCO (Central Drugs

Standard Control Organization) which is regulated by directorate general of health services, ministry of health and family welfare, government of India.

CDSCO is only government body which regulates medical devices.

IMRDA (Indian Medical Device Regulatory Act) had been set up for their opinion and recommendation.

The import, manufacturing, distribution, sale of medical devices in India is overseen by drug and cosmetic act (1940) and rules (1945).

Inspection and controls are carried out by CDSCO.

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India’s medical device regulatory structure

Drug controller India

Deputy drug controller

Assistant drug controller

Medical device

Drug inspector

Technical data associates

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Document required for the medical device registration certificate

1. Covering latter: States application and lit all the documents being submitted with the application.

2. Authorization latter: Identifies Indian authorized agent.3. Form 40: General medical device registration application form.4. TR6 challan: Registration fees payment-$1500 per site, $1000 per

device.5. Power of attorney: Necessary for proof of authorization from

manufacturer to India authorized agent.6. Schedule DI and plant master file: Information on device and

manufacturing site.7. Schedule DII and device master file: Information on intended use,

indication of use, classification and any novel features, clinical data, post market surveillance data.

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8. Wholesale license: Permit our Indian authorized person to act on behalf of us.

9. Free sale certificate(FSC): Must be from device country origin.10. Manufacturing license: Must be issued by the regulator of the device’s

country of origin; also known as establishment registration certificate.11. ISO 13485: 2003 certificate: must be in place for the foreign

manufacturing site.12. QA certificate: Must be in place for the foreign manufacturing site.13. CE design examination certificate: Must be in place for device.14. Declaration of conformity: Must be in place for device.15. Inspection/audit report: Carried out by appropriate notify body,

national regulatory authority or competent authority.

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Registration stepsStep 1

TR 6 challan (bank of Baroda, New Delhi) for registration fees1,500US dollars

Application is given in form no. 40

It gives permission to manufacture and import of medical device in India foruse.

1000US dollars for each additional medical device

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Step 2: Compilation of registration dossier as per regulatory guidelines.

Step 3: Submit product registration application at CDSCO Delhi headquarter.

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Payment of feesThe fee shall be paid through a challan in the bank of Baroda, kasturbaGandhi Marg new Delhi 110001 or any other branch or branches of bank ofBaroda or Any other bank notified, from time to time by the central govt., tobe credited Under the Head of Account “0210 Medical and public health, 04-public health, 104- fee and fines

In case of direct payment of fees by manufacturer in the country of origin thefees shall be paid through electronic clearance system(ECS), and the originalreceipt of the said transfer shall be treated as an equivalent to the bankchallan, subject to the approval by the Bank of Baroda that they have receivedthe payment

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Time frame

If the application is complete in all respects and information specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.

A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.

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GTU Questions1. Discuss the regulations on the medical devices in India.

(2013)2. Describe the registration process for medical devices in

India. (2013)3. Classify the medical devices. (2013)4. Discuss a common framework required in medical device

regulation.(2015)5. Classify medical devices and discuss in brief registration

process of medical device in India. (2015)

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References

1. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

2. http://www.jpsbr.org/index_htm_files/JPSBR14RV3025.pdf3. article_wjpps_1430376482.pdf4. http://cdsco.nic.in/writereaddata/FAQ-IMPORT-&-REGISTRATION-

02022013_DONEE.pdf5. pharmamedix.in/journals/index.php/IJPI/article/download/30/pdf