In re: Submitting New 510(k) Notifications
- Case Date: 11/13/2016
- Project Name: Health Care Project
On November 11, 2016, WLF filed formal comments with the Food and Drug Administration (FDA), largely applauding FDA’s recently issued Draft Guidance to medical device manufacturers regarding when changes to an existing device require the manufacturer to file a new 510(k) notification with FDA. WLF stated that the Draft Guidance provides manufacturers with a much-needed roadmap to be used in deciding when a new 510(k) must be filed. WLF took issue, however, with language in the document suggesting that manufacturers could make unilateral changes in their FDA-approved device labels without first obtaining FDA approval for the new change. WLF argued that granting this unilateral-revision right is a major regulatory change that FDA may adopt only after engaging in formal notice-and-comment rulemaking. WLF objected that the proposed change could significantly expand device manufacturers’ exposure to products-liability litigation.
|Awaiting FDA response.|
More Information and Downloads:
11/13/2016: Download the Comments