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Respironics California, a Philips subsidiary, received an FDA warning letter for medical device reporting failures, including one related to a life-sustaining/life-supporting device. Read More
MedOne Surgical, a Sarasota, Fla., devicemaker, received an FDA Form 483 for failures related to complaint records, in-process acceptance and other procedures. Read More
House and Senate lawmakers are teaming up on an overhaul of FDA device procedures, including expanding the use of third-party quality audits. Read More
Important details on unique device identification, such as transition times, are missing from the EU’s draft medical device regulation, a major industry group says. Read More
In a 46-page draft guidance released Jan. 26, the U.S. FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
Beginning Jan. 26, labelers of implantable, life-supporting and life-sustaining devices that are not Class III were able to register with the FDA’s Global Unique Device Identification Database. Read More
CDRH Office of Compliance Director Steve Silverman told senior staff that he was leaving the FDA last month to pursue opportunities outside the government. His last day at the agency was Jan. 16, according to an internal memo provided to GMP. Read More
Ensuring that product components and supplies are of top quality and delivered on time is key to running a successful business, and supplier qualification surveys need to be sufficiently broad to ensure a good result, an industry expert says.
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