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The FDA released a revised guidance clarifying when device sponsors that make certain low-risk product changes may not have to submit supplements for already approved premarket approvals (PMAs) or humanitarian device exemptions (HDEs) during the COVID-19 public health emergency. Read More
FDA investigators issued a four-observation Form 483 to Suture Concepts, a manufacturer of soft-tissue management devices, following a December inspection of the company’s Beverly, Mass., facility. Read More
Belgium-based Ion Beam Applications (IBA) has acquired Modus Medical Devices, a Canadian manufacturer of “phantoms” used for quality assurance in radiation therapy. Read More
The FDA has issued a warning about counterfeit COVID-19 test kits that are being marketed in the U.S. — including fake Flowflex COVID-19 test kits and iHealth COVID-19 antigen rapid test kits. Read More