More FDA Review And Decision Data
For first-in-class devices or major new device indications going through FDA, 2015 was a banner year.
FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?
Approvals of PMAs and panel-track supplements, as well as de novo devices, hit a 15-year high in calendar year 2015, according to a "Gray Sheet" analysis. FDA and industry experts respond to the data; also, check out our infographic of 2015 FDA approval trends, including a tally of the firms that captured the most PMAs and 510(k)s last year, and more.
More from Regulation
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Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.
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From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
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Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
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Overlapping clinical testing requirements and decision-making around significant changes to MDAI are among the tricky subjects that the new document explains.
More from Policy & Regulation
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After multiple warning letters and safety communications, the US FDA has decided to block the import of certain endoscopes from Olympus. In total, the agency’s action pertains to 58 device models manufactured by the Japanese firm used in urinary, respiratory, abdominal and pelvic procedures.
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Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
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From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.