FDA Finalizes 510(k), PMA, eCopy Guidances
This article was originally published in The Gray Sheet
FDA spells out its acceptance policies for 510(k) and PMA submissions, as well as guidelines for submitting electronic copies of submissions. The guidances all aim to make the device review process more efficient and speedy.
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If the pilot works out, sponsors will be allowed to submit premarket applications using a cloud server in addition to mailing paper copies of their documents.
According to an updated guidance on FDA’s eCopy submission program, it now accepts a broader range of PDFs. The update contains expanded guidelines for industry when submitting electronic versions of applications to FDA.
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.