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An FDA inspection of Prime Lab USA’s facility in Miami, Fla., landed the company a Form 483 for inadequately storing product, evaluating suppliers and handling customer complaints, among other lapses.
The FDA explores the blurred regulatory line between medical device software and non-device software functions in a new report that concludes the benefits of non-device software outweigh the risks.
In a nod to the increasing development of three-dimensional visualization tools, the FDA has created a new page on its website devoted to listing augmented and virtual reality medical devices.
The FDA published a draft guidance Thursday that lays out a risk-based framework to guide review staff and device manufacturers on what human factors information to include in a marketing submission to the Center for Devices and Radiological Health (CDRH).
To help manufacturers better understand and make use of the FDA’s four-year-old Voluntary Summary Malfunction Reporting (VMSR) program, the agency released draft guidance on Thursday to explain — but not change — the conditions of the VMSR. Read More
The U.S. Patent Trial and Appeal Board (PTAB) stood with Apple in its complaint that former partner AliveCor’s claims on the technology behind wearable Afib detection were unpatentable.