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USFDA Guidance: Premarket Notification [510(k)] Submissions

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidance this Thursday (07 September 2023), to modernize Premarket Notification [510(k)] Submissions.

The term "510(k)" refers to the section of the Federal Food, Drug, and Cosmetic Act, which requires device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. The purpose of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed "predicate" device, which means it is as safe and effective as the predicate device.

This guidance provides additional clarity and context for situations when clinical data may be necessary to demonstrate substantial equivalence. In addition to advancing safety and innovation, the recommendations will promote consistency and facilitate the efficient review of 510(k) submissions with clinical data. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review.

The recommendations in this draft guidance are intended to serve as a primary resource for all implant devices for which a 510(k) is required, while device-specific guidance documents may provide additional specificity for a given device type. This guidance is intended to promote consistency and facilitate an efficient review of implant devices that are covered by 510(k).

The recommendations in this draft guidance suggest factors for consideration as best practices for choosing a predicate device that focus on characteristics of the predicate, including selecting a predicate device that was cleared using well-established methods, meets or exceeds expectations for safety and performance, is free from unmitigated use-related or design-related safety issues, and is not recalled because of its design.

These above 3 guidances mainly discuss the modernization of Premarket Notification [510(k)] Submissions, In addition on 08th September 2023, another guidance was released "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

This guidance document also incorporates several considerations, including how to determine whether biocompatibility testing is needed based on risk, chemical assessment recommendations, recommendations for preparing biocompatibility test articles for devices made from polymerizing or absorbable materials made in situ, and recommendations for biocompatibility when certain materials only contact intact skin.


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