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The FDA should exempt certain biologic grafts from its “sweeping proposed reclassification” of surgical mesh, Cook Biotech says in comments on a proposal to place mesh for transvaginal pelvic organ prolapse repairs in Class III. Read More
The International Medical Device Regulators Forum has released two final guidance documents aimed at easing the filing process for marketing authorizations of medical devices and in vitro diagnostic devices in multiple countries. Read More
ProTech Professional Products received an FDA warning letter for problems with its corrective and preventive action and complaint procedures and for failing to notify the FDA of significant device modifications. Read More
The FDA is looking for participants for a pilot program that will help the agency design and validate regulatory tools for use in developing new technologies. Read More
Swedish devicemaker XVIVO Perfusion has garnered an FDA’s humanitarian device exemption to market its donor lung preservation technology in the U.S. Read More
A federal judge in multidistrict litigation involving injuries caused by transvaginal mesh threw out motions from both plaintiffs and defendant Ethicon, saying they were “silly” and unsubstantiated. Read More
The FDA has published a unique device identification compliance guide aimed at helping small manufacturers prepare for UDI implementation, the first stage of which comes due next month. Read More
Manufacturers may soon be able to check how their devices are progressing through the 510(k) review process, under an experimental program being developed by the FDA. Read More
The FDA and Centers for Medicare & Medicaid Services have approved the first product ever under the two agencies’ joint pilot program for parallel review – Exact Sciences’ Cologuard, a noninvasive screening test for colorectal cancer. Read More
Makers of low and moderate risk devices can now use the FDA’s de novo pathway to gain approval without first filing for 510(k) clearance – and the FDA wants to encourage more devicemakers to take advantage of the pathway. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, an industry observer says. Read More