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The FDA has reversed a Trump Administration policy that was set to exempt 83 class II devices and one unclassified device from premarket notification requirements. Read More
Adverse events reported in MAUDE alone are an inappropriate basis for exemptions because adverse events may be under reported for certain devices and may not necessarily reflect the risk of injury, the agency noted. Read More
The standards should include detailed technical specifications in relation to the requirements set out in the new EU regulations, the commission said. Read More
Operation Quack Hack includes a team of consumer safety officers, special agents and intelligence analysts who triage incoming complaints about fraudulent and unproven medical products. Read More
Establishing the EU reference laboratories (EURLs) for a range of Class D devices has been identified as an important priority and the European Commission is working on introducing the criteria and fees for the EURLs. Read More
The complaint alleged that the devices “were not properly cleared for any use” and “they cannot be used for their labeled intended use (and are thus not substantially similar to the predicate device).” Read More
The FDA has reversed a Trump Administration policy that was set to exempt 83 class II devices and one unclassified device from premarket notification requirements. Read More
The Philippines Food and Drug Administration issued draft guidelines on its new eServices Portal System for medical devicemakers and distributors to help them transition their license to operate (LTO) applications. Read More
The European Commission is calling on EU standardization groups to revise more than 200 existing harmonized standards and to draft 27 new standards over the next three years in support of the EU’s Medical Device Regulation and In Vitro Device Regulation. Read More
The FDA has issued five new warning letters this month related to misbranded and adulterated COVID-19 tests, as the agency continues to urgently target manufacturers and suppliers of unapproved COVID-19 products. Read More
The U.S. Ninth Circuit Court of Appeals has ruled that a whistleblower lawsuit alleging that Medtronic fraudulently obtained a 510(k) from the FDA can proceed, but it dismissed separate off-label promotion claims. Read More