HOME  |  CONTACT US  |  SUBSCRIBE  |  SUPPORT WLF

Case Detail


In re: Submitting New 510(k) Notifications
On November 11, 2016, WLF filed formal comments with the Food and Drug Administration (FDA), largely applauding FDAs recently issued Draft Guidance to medical device manufacturers regarding when changes to an existing device require the manufacturer to file a new 510(k) notification with FDA. WLF stated that the Draft Guidance provides manufacturers with a much-needed roadmap to be used in deciding when a new 510(k) must be filed.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.
Case Status:
Awaiting FDA response.
More Information and Downloads:
11/13/2016: Download the Comments

  • Welcome to the Washington Legal Foundation
  • 2009 Massachusetts Ave., NW
    Washington, DC 20036
  • info@wlf.org  |  ph. 202-588-0302
    ©2017 WLF All Rights Reserved