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Health Canada issued a notice explaining how it classifies ultraviolet (UV) light-emitting decontamination products making COVID-19 claims and the pathways for market authorization. Read More
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 FDA’s Gastroenterology and Urology Devices Advisory Committee voted in support of FDA approval for Transmedics’ Organ Care System (OCS) in a July14 meeting. Read More
Italy’s Kiwa Cermet Italia SPA has become the 21st notified body to be certified under the EU Medical Device Regulation, which went into effect on May 26. Read More
An FDA inspection of Smiths Medical’s Minneapolis facility revealed validation lapses, complaint handling procedures that weren’t handled correctly and inadequate corrective and preventive action (CAPA) procedures. Read More
Quality audits were not being performed at sufficient intervals, and management with executive responsibility had not reviewed the effectiveness of the quality system at defined intervals, the FDA said following an inspection of MedHab’s Arlington, Texas plant. Read More