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General Physiotherapy was hit with a Form 483 after an FDA investigator observed product testing and other quality deficiencies at the company’s Earth City, Mo., facility. Read More
Within days of the reauthorization by Congress of the FDA’s user fee programs for the next five years, the agency posted its fiscal 2023 device user fees – increasing most of them by a hefty 18 percent and a couple by more than 50 percent. Read More
The FDA offers advice on postmarket surveillance and postapproval studies for moderate and high-risk devices in two final guidance documents released yesterday. Read More
Pfizer has completed its acquisition of Australian diagnostic software developer ResApp Health for $115 million, expanding its reach into digital health products. Read More