Industry Says FDA’s “Refuse To Accept” 510(k) Guidance Is Too Subjective
This article was originally published in The Gray Sheet
Medical device firms generally support FDA’s “Refuse to Accept Policy for 510(k)s” draft guidance but have qualms with some of the new submission acceptance criteria the agency outlines.
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Results of the planned June audit will be of significant interest to a number of device companies that claim FDA reviewers have erroneously crossed into substantive review territory in applying the new "quick review" procedure.
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.
For now, CDRH remains in a transition phase on its new refuse-to-accept policies for PMA and 510(k) submissions and its mandate for electronic copies of pre-market submissions, each of which have been addressed in recent guidance documents.