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The FDA has extended the comment period for its draft guidance on LASIK devices by 30 days in response to multiple requests by device groups. 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
Flawless Beauty and Skin is importing and marketing unapproved devices, according to a warning letter the FDA sent the Ocean, N.J., firm following an inspection at that facility Nov. 16, 2021, through Jan. 19, 2022. Read More
The FDA has released three final guidances spelling out its product review goals and timing under user fee commitments negotiated with industry for the Medical Device User Fee Amendments (MDUFA) program reauthorized by Congress on Sept. 30. Read More
The FDA expects to gain insights from the real-world perspective of Veterans Health Administration (VHA) clinicians and scientists under a newly announced collaboration between the agencies aimed at interoperable medical devices. Read More
Legislation to reauthorize the FDA’s user fee programs passed the House of Representatives on Friday in a vote of 230 to 201 as part of a continuing resolution (CR) to fund the federal government through Dec. 16. The CR passed in the Senate the night prior in a bipartisan vote of 72 to 25. Read More
San Mateo, Calif.-based Cala Health’s Trio device reduced essential tremor (ET) an average of 71 percent in patients in a two-year real-world evidence study, according to results published in the peer-reviewed journal Tremor and Other Hyperkinetic Movements. Read More
Med Pen Concepts’ Plasma MD and Plasma +, products intended to improve the appearance of skin by stimulating the production of collagen, are not approved by the FDA and are not manufactured using current good manufacturing practice requirements, the agency said in a warning letter to the company. Read More