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CDRH is expecting a large number of devicemakers to take advantage of the Expedited Access PMA program proposed in draft guidance in April, center Director Jeffrey Shuren said during a Thursday webinar hosted by the Pew Charitable Trusts. Read More
The FDA’s recent approval of a gene-based diagnostic to improve blood matching before transfusions is just the first step for a technology that could vastly improve patient care, a panel of experts said recently. Read More
The FDA’s Circulatory Systems Devices Panel overcame concerns about data disparities and limited follow-up to unanimously recommend approval of a first-in-class catheter to treat peripheral artery disease in the leg. Read More
Bowing to industry pressure, the FDA said Thursday it is withdrawing a rule to move cranial electrotherapy stimulators to Class III and will continue to regulate the devices in Class II with special controls. Read More
Manufacturers of some cellulite-reduction devices may have an easier time bringing their products to market, thanks to an FDA reclassification order. Read More
Manufacturers of ultraviolent sunlamps used in tanning beds have 450 days to submit 510(k)s on lamps now in use, an FDA final reclassification order on the preamendment devices says. Read More
As 3D printing gains popularity among medical devicemakers, the FDA wants to get advice from manufacturers and researchers to guide its product reviews and, possibly, future guidance. Read More
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More