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The FDA finalized guidance on the evaluation process for De Novo classification requests and issued draft guidance on the acceptance criteria. Read More
Production workers at ATS Manufacturing threw out all of the nonconforming products they found and failed to document any follow-up activities over the course of nearly four years, an FDA investigator discovered in an August 14-18 inspection. Read More
Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance. Read More