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A premarket notification summary for the Hermes dental filling composite, outlining its safety, effectiveness, and substantial equivalence to predicate devices.

How to fill out 510k summary of safety

How to fill out 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Begin with a cover page that includes the device name, submitter's name, and contact information.
2. Provide a table of contents for easy navigation of the summary.
3. Start with a brief description of the device and its intended use.
4. Detail the device specifications including design, materials, and technological characteristics.
5. Compare your device to similar legally marketed devices (predicate devices) and discuss similarities and differences.
6. Present data from clinical studies, if applicable, including the methodology and results, to demonstrate safety and effectiveness.
7. Include information on biocompatibility testing and any other relevant safety evaluations.
8. Summarize risk analyses and the management of any identified risks associated with the device.
9. Clearly outline the labeling that will accompany the device, including instructions for use.
10. Conclude with a statement of the intended audience and a declaration of compliance with FDA requirements.

Who needs 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS?

1. Manufacturers of medical devices that are seeking FDA clearance to market their products.
2. Companies that plan to introduce new medical devices that are similar to existing marketed devices.
3. Any organization or individual involved in the production or distribution of medical devices in the U.S. market.

People Also Ask about

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is the difference between FDA 510k and CE?

CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards. A 510(k) is a premarket submission made to the FDA.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What is the 501k process?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What are the different types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are the three types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

For pdfFiller’s FAQs

What is 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS?

The 510(K) Summary of Safety and Effectiveness is a document submitted to the FDA that provides evidence that a medical device is safe and effective for its intended use, comparing it to a similar, legally marketed device.

Who is required to file 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS?

Manufacturers or sponsors of medical devices that seek to market a device that is not substantially equivalent to a previously marketed device must file a 510(K) Summary of Safety and Effectiveness.

How to fill out 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS?

Filling out a 510(K) requires gathering information about the device, including its intended use, technological characteristics, comparisons to predicate devices, clinical data, labeling, and adherence to applicable standards, and submitting this information in accordance with FDA guidelines.

What is the purpose of 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS?

The purpose of the 510(K) Summary of Safety and Effectiveness is to demonstrate to the FDA that a medical device is safe and effective, allowing it to gain clearance for market entry without going through the more rigorous premarket approval process.

What information must be reported on 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS?

Information that must be reported includes the device's name, manufacturer details, intended use, description of the device, significant technological features, comparison to predicate devices, clinical data if applicable, and any safety and effectiveness information.