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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
Sen. Patrick Leahey (D-Vt.) effectively killed any chance at patent reform legislation last week by removing H.R. 1720 from the agenda of the Senate Finance Committee, which he chairs. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than is provided in a related House bill. Read More
Only devices that violate the 1938 FD&C Act should be labeled Import for Export, FDA officials cautioned at the recent FDA/Xavier University MedCon conference. Read More
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
The National Institute for health and Care Excellence has updated its advice on the most clinically and cost-effective choices for devices to treat irregular heartbeats or heart failure. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two branches in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, under an experimental program announced May 1. Read More
The China Food and Drug Administration received nearly 239,000 reports of device adverse events in 2013, with overall quality of adverse event reporting improving, the agency said earlier this month. Read More
Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The Therapeutic Goods Administration is updating its guidance on the collection, maintenance and disclosure of commercially confident information, focusing on eight principles agency staff should consider in disclosing submitted information. Read More
The U.S. Food and Drug Administration may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by factors such as postmarket controls, the agency says in an April 23 draft guidance. Read More