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Remote audits are turning up roughly the same number of non-conformities as seen in onsite audits, a majority of EU notified bodies said in response to a survey. Read More
The FDA issued a long-awaited final rule on the agency’s current practices in evaluating whether a product is intended for use as a drug or device. Read More
The FDA expects to collect almost $263 million in user fees from devicemakers in fiscal year 2022 and it is increasing registration and application fees across the board. Read More
The FDA has accredited 68 testing laboratories so far under its Accreditation Scheme for Conformity Assessment (ASCA) pilot, in which testing labs may be accredited by accreditation bodies to assess the conformance of a device with certain FDA-recognized standards. Read More
In a significant policy shift, the FDA is going to reclassify some medical products as devices rather than drugs, in accordance with an April 16 ruling by the U.S. Court of Appeals for the District of Columbia Circuit, the agency said in an Aug. 9 Federal Register notice. Read More
The warning letter is among a recent spate of letters by the agency aimed at stopping the marketing of unauthorized products related to the COVID-19 pandemic. Read More