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The FDA is placing an ever-keener eye on device manufacturers’ purchasing controls, including supplier qualification processes and vendor-related record keeping, as an important part of its Quality System Inspection Technique (QSIT). Although the FDA considers purchasing controls to be a routine part of even the most basic QSIT inspection under the Production and Process Controls section of the Quality System Regulation (QSR), devicemakers are failing to meet basic requirements of 21 CFR 820.50 time and again. Read More
The United Kingdom is reinventing its medical device regulatory framework now that it’s no longer in the European Union, and the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is asking for public comment on “possible changes to the regulatory framework” for devices. Read More
A device manufacturer that undergoes an FDA inspection and gets a Form 483 with findings may avert a warning letter from the agency if it “really responds well,” said Jodi Scott, a partner at Hogan Lovells US, speaking Wednesday at the WCG and FDAnews-sponsored FDA Inspections vSummit. Read More
Trend data on complaints are only as good as the individual complaints providing the information. Not all complaints are equally valid — and some are, in fact, fraudulent. Read More
A federal judge has cleared Pfizer’s $345 million settlement resolving claims the drugmaker overcharged for its EpiPen epinephrine self-injector for treatment of severe allergic reactions. Read More
The FDA’s Safer Technologies Program (STeP) for Devices provides similar agency resources and priority review to sponsors whose devices do not meet the criteria for breakthrough status. Read More