Final FDA Bill: Device Provisions
This article was originally published in The Gray Sheet
Congress has settled on final language for the FDA Safety and Innovation Act. After Senate approval, the bill will go to the White House for President Obama’s signature.
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The agency will take into account patient preferences when making benefit-risk determinations for investigational device exemptions, according to a June 18 draft guidance.
FDA’s draft guidance defines terms used in its custom device exemption, which limits the production of such devices to “five units per year of a particular device type,” and provides recommendations for information to be included in annual reports.
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.