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The FDA is legally bound to stay within the scope of its authority and its investigators do, generally. However, if you refuse the FDA access to records that the agency is legitimately entitled to, that is called committing a prohibited act and there are consequences and potential penalties for such refusals. 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
The FDA has clarified that it does not plan to regulate most software apps used in public health — such as the case-counting software programs that have been in use throughout the pandemic — as medical devices. Read More
The FDA is making significant organizational changes to the Center for Devices and Radiological Health (CDRH), which plays a lead role within the agency in how medical devices are evaluated or cleared for clinical investigations and marketing. Read More