Medical device regulations 510k

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https://www.sigmabiomedical.com

Medical Device Regulations510(k) Premarket Notification Principles

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Welcome!

Thank you for watching this introductory presentation on medical device regulations and the 510(K) Premarket Notification Process.

We hope you find this presentation helpful and informative. For more information, please visit us at

http://www.sigmabiomedical.com

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Note to the Viewer

In this presentation we want to outline the principles of medical device regulations and the 510k

Premarket notification process for an efficient product approval with the FDA.

Instead of presenting the 510K process from a pure regulatory approach of outlining the 510k

premarket notification process, we want to present the concept behind device regulations so it

can be understood, taken into account and effectively implemented from and during the product

development and manufacturing process.

We believe this approach will help medical device manufacturers stay in compliance, obtain

market clearance and provide a safe and effective product to their consumers

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Need for Medical Device Regulations

Medical Device Compliance Areas

FDA Regulations for Medical Devices

In this short presentation we are covering the following topics

510(k) Premarket Notification Process

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Medical products intended to diagnose,

treat, manage or mitigate a disease

condition may cause injuries on patients

•Product development and manufacturing engineers need to determine, analyze and address potential risks medical products pose to patients. Risks include direct or indirect patient harm, wrong diagnoses or improper treatment and disease management processes.

Need for Medical Device Regulations

•Risks can be caused by weak product design, lack of adherence and compliance to safety standards, material and component failures or improper device use.

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Lack of proper controls and quality procedures cause weaknesses in the design and manufacturing, which in turn prompt the devices to malfunctions.

Labeling Improper device labeling including inaccurate or insufficient user instructions can cause operator errors increasing safety risks to patients.

Electrical SystemsFailures in electronic design can cause electrical safety hazards such as high leakage currents that can harm patients and operators

Electromagnetic InterferenceImproper grounding and shielding cause devices to emit or receive radiation beyond allowable limits; potentially affecting or interfering with device operation

Radiated EnergyRadiated energy beyond limits cause injuries and bio effects on biological tissues.

SoftwareSoftware bugs and lack of software validation and verification can cause incorrect measurements, wrong diagnosis and improper treatment settings

Some of the risks and their effects include

Quality

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Although medical devices can benefit and be a useful

tool to improve the health of patients, they can also cause

harm

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• We then need a balance between benefits and risks to ensure new medical products are developed, manufactured, introduced and used in a safe and effective manner.

Benefits vs RisksMaximizing Benefits - Minimizing Risks

• The Food and Drug Administration FDA has been established as an agency in charge of promoting and protecting public health. The FDA has the power to supervise and enforce regulations related to the marketing and safe and effective use of medical and health products.

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The FDA protects consumers • To keep a balance between

benefits and risks of medical products, the FDA sets regulations for the manufacturing, marketing and distribution of medical and health products including medical devices, drugs, cosmetics, food and biological products.

• The FDA establishes controls and regulations to protect consumers from the risks of medical and health products and the negative effects they can cause on the patients’ and consumers’ health

SigmaBiomedical

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What are the main Medical Device Regulation Areas to ensure Patient Safety and Device Effectiveness?

Labeling, Claims and Intended Use of products

Product Safety & Effectiveness

Product Development and Manufacturing operations

Product Registration, Records,

Customer Complaints & Adverse

Reactions

Medical Device Compliance Areas

We will briefly discuss each of these areas of compliance

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To make sure the technology and

intended use of the product have been clinically validated

and proven effective

To make sure products are properly

labeled and safely used according with their intended use

To make sure benefits and claims are

substantiated by performance data as well as by scientific

and clinical evidence

Intended Use, Claims and LabelingWhat is the importance of intended use, proper claims and labeling?

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Not validated technology“Quack” technology with lack of clinical studies. No scientific principles behind the technology and mechanism of action

Some non compliant Cases

Not validated Claims and misleading statementsDevices that claim they can diagnose any type of disease. Augmented adjectives: The “best imaging technology”

Insufficient instructions for useInstructions are not clear to the user. Not warning messages. No safety precautions. No declared indications for use.

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To minimize risks and to

ensure patient safety

To minimize adverse product

interactions

To ensure effectiveness for their intended

use

Importance of Product Safety & Effectiveness

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Cancer Treatment Device25 MeV Radiotherapy Machine – X-rays & Electrons. 200 rad (e) or 25000 rad (x)

System Setting ErrorError on selection, Software bug, Beam not reset. No maximum output controlled

Error EffectsPatient received 25000 MeV, “malfunction 54 displayed”. Technician fired 2 more times4 months later patient died

Failure Mode CaseSoftware Bug, Lack of Training, Improper Labeling

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01 Manage RiskImplement Risk Management Policies and Procedures for products, manufacturing processes and business operations

02 Control DesignFollow design controls & engineering standards in product development

03 Manage QualityA proper quality management system needs to be implemented in operations

04 Use Safe Materials Materials and components need to be medical grade or generally recognized as safe

05 Test and ValidateAccording to safety standards to make sure product is safe. Testing can reveal weak and non-compliant areas

06 Monitor Device UseFollow, and document customer complaints and take proper action

6 Ways to Product Safety

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To protect consumers and patients, the FDA regulates and establishes controls for the marketing, manufacturing and distribution of Medical Devices and Health Products.

FDA Regulations for Medical Devices

The controls and regulations are aimed to maximize benefit, minimize risks and guarantee a safe and effective use of products

FDA regulations depend on the type of product and their risk level. The higher the risk the more strict the controls and regulations

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Medical devices are classified by the FDA and grouped into 16 medical categories referred to as panels. A medical device is assigned to a class based on the level of control to assure product safety and effectiveness. The classes are:

• Class I

• Class II

• Class III

Medical Device Classification

Device classification depends on the risk level of the device, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

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•Medical products need to be listed or registered with the FDA before they can be marketed in the US. This ensures a good level of control by the FDA on the product marketing and distribution.

Medical Device Registration

•Prior to being listed, and depending on classification, medical devices might need to go through a process of device evaluation by the FDA

•The process evaluates product safety and effectiveness, as well as validity of claims, intended use, indications for use and labeling

•To start the process, a submission seeking market clearance needs to be started with the FDA by the manufacturer or sponsor of the product

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Two types of medical device clearance submissions exist: 510k Premarket Notification and Premarket Approval PMA. Some devices are exempt from these submission requirements and only need to be listed

Types of Product Submissions

The class to which a particular medical device is assigned and its risk level determines the type of submission required for FDA market clearance.

If the device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.

For Class III devices, a premarket approval application (PMA) will be required unless the device is a preamendments device and PMA's have not been called for. In that case, a 510k will be the route to market.

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•The FDA provides a general guidance on how to submit a 510k Premarket Notification. It can be searched on the Web under FDA 510k guidance

510(k) Premarket Notification Process

•Special guidance documents exist depending on the product type and product code.

•The guidance document specifies ways to demonstrate safety and effectiveness for the type of product being reviewed•The 510k process is mainly aimed to demonstrate the product is safe and effective for their intended use, and that the product is substantially equivalent to an already cleared product

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• That the technology and action principle for the intended use of the product has been previously evaluated and found effective for other similar products using the same technology with similar manufacturing processes and materials

Substantially equivalence SE, implies

• The action principle and technology do not introduce new safety or effectiveness concerns as it has been previously evaluated and demonstrated in scientific and clinical literature for the intended use.

• In many cases it also means that similar products have been on the market prior to 1976. For this reason, clinical data most likely will not be needed. FDA will thus rely upon well-designed bench and animal testing to demonstrate adequate performance.

• The product has been tested and by performance data found safe and effective for their intended use

• Product labeling is according to the intended use; claims are substantiated by scientific and technical evidence, and user instructions ensure safe use of the product

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Product code and classificationThis section will tell the FDA the classification panel for the subject device so the submission gets directed to the proper review team for evaluation

Main elements of a 510k Submission Document

Device DescriptionThis will provide the FDA reviewers with a clear and concise description of product features, specifications, functionality, technology and mechanism of action.

Predicate device comparison This section is aimed to compare the subject product to an already cleared device to demonstrate that they are similar in technology, mechanism of action, materials and manufacturing process, and thus no new safety or effectiveness concerns are introduced

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Performance Data to address Risks to HealthThis is aimed to demonstrate safety, and or compliance with safety standards. It is also aimed to show that product features have been successfully verified and validated for their intended use. Risk management needs to be demonstrated.

Materials and Component CharacterizationIf applicable, this section is aimed to demonstrate that patient contact materials are biocompatible and do not cause or pose risks to health.

Labeling This is aimed to show the FDA reviewers that proposed manuals, brochures and promotional materials provide sufficient information for the safe and effective use of the product according with the intended use. FDA will review labeling to make sure no unsubstantiated claims are included

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Administrative forms and paymentThe submission needs to include: • Proof of payment of FDA fees for 510k review• Medical Device User Fee Cover Sheet (Form FDA 3601).• Certification of Compliance with ClinicalTrials.gov Data Bank,

FDA-3674*• Cover Letter• Indications for Use• 510k Summary• Standards Data Report for 510(K)s - FDA 3654.• Truthful and Accuracy Statement (21 CFR 807.87(k))

Main elements of a 510k Submission Document

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080904.htm

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM081667.pdf

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Find and Analyze Similar Devices (Predicate devices)From the FDA medical device database or Web search, find devices that are similar in technology, mechanism of action, and intended use to your device. Find from the results, product code, classification and 510k summary. From 510k summary determine product description, and performance data or testing standards, if included.

Some initial tips to prepare a 510(k)

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Some initial tips to prepare a 510(k)

Analyze Applicable RegulationsFrom product code find applicable regulations. Check guidance and from there required testing to address risks to health. Analyze recommended documentation

Setup approval strategyDetermine approvable product features, functionality and their corresponding testing, validation and verification activities. Define intended use and claims so these are similar to predicate devices’. Make sure labeling is correct and addresses all required items. Do a check list of 510k requirements.

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Pre-submission

510(k) Preparation

510(k) Review

Start

Predicate Analysis, classification, product code

Analysis of applicable Regulations – guidance, strategy

Administrative review for 510k document completeness

510(k) interactive Review – Answer Requests

Time line of events to prepare a 510(k)Example of time line

Performance Data, testing, validations

Market Clearance

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week2 week4 week6 week8 week10 week12 week14 week16 week18 week20 week22 week24 week26

Product review

Predicate analysis

Regulatory analysis

Performance data

510k preparation

510k submission

Administrative acceptance

510k Interactive Review

Clearance

510k Project Gantt Sample*

*time line differs based on product type, as well as on existing and needed testing and performance data when 510k process starts

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510(k) Submitted Administrative Review, Interaction & Acceptance

Interaction with FDA Reviewer and feedback to

solve issues

SE LetterMarket Clearance

Time Line for 510(k) Clearance

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USA

Hialeah Technology Center601 West 20 StHialeah, FL 33010Tel (305) 925-1260

Colombia

Campus NOVAUniversidad JaverianaCali, ColombiaTel 316-833-8183

Argentina

Gabriela MennaBuenos Aires, [email protected]

Email / Website

[email protected]

Get in touch with us!

mailto:[email protected]

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Medical device regulations 510k