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Sponsors of companion diagnostics should submit applications to the FDA simultaneously with the drug product submission to improve the chances that the test on which the treatment relies is available when the drug is approved, an FDA final guidance says. Read More
For the first time, the FDA will begin regulating manufacturers of high to moderate risk laboratory-developed tests, a move that reverses the long-standing agency position that LDTs were not subject to FDA oversight. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
The FDA’s draft guidance on distinguishing recalls from product enhancements contradicts current regulations, creating “a new sort of burden for industry,” an attorney says. Read More
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, which is used with its Renasys line of negative pressure wound treatment devices. Read More
Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized FDA guidance on substantial equivalence determinations. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
The China Food and Drug Administration has ordered 18 devicemakers to stop publishing advertisements that make false claims about the effectiveness of their products — a move some say shows a new willingness by the government to crack down on illegal ads. Read More
Medtronic’s pending $45 billion acquisition of Covidien was in the congressional spotlight after a recent call by U.S. Treasury Secretary Jack Lew to pass bills limiting corporate inversion deals. Read More
Legislation to allow the Centers for Medicaid & Medicare Services to make coverage decisions more quickly could be on deck before the end of the year, lawmakers suggested during ongoing hearings on the House Energy & Commerce Committee’s 21th Century Cures initiative. Read More
The FDA’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More