The FDA issued revised guidance documents earlier this year clarifying the agency’s ‘Refuse to Accept’ policy for 510(k)s and PMAs. The updated policy raises questions for companies developing and submitting combination products for regulatory approval, according to lawyers Allyson Mullen and Rachael Hunt.
The associate partners detailed changes to the components that companies must include in a 510(k) or PMA in order for the FDA to accept it for review. The updated list of requirements now includes a mandate for companies to identify whether or not their proposed offering is a combination drug-device product.
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