Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management
This article was originally published in The Gray Sheet
As FDA prepares a report due to Congress in January on its policy for determining when a modified device needs a new 510(k), industry representatives say major changes are not necessary to the current process. But they suggest some tweaks that could make things work more smoothly.
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In a report to Congress, FDA stuck with device industry recommendations to merely revise its 1997 guidance on 510(k) device modifications, rather than to more thoroughly revamp the policy.
CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.
CDRH Director Jeffrey Shuren told participants at the AdvaMed annual meeting to expect early feasibility studies final guidance very soon and a guidance on 3D printing within two years. The center also announced updates on its national post-market surveillance plan and 510(k) refuse-to-accept policy programs, among other matters.