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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In a 46-page draft guidance released Jan. 26, the U.S. FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality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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Devicemakers whose products include a drug component could find GMP compliance especially tricky, due to a 2013 regulation that requires expiration dates like those used for drugs, an industry expert says. Read More
The U.S. Food and Drug Administration plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More
The European Commission is again seeking to calculate the potential risks of the plasticizer di(2-ethylhexyl) phthalate in medical devices, saying there is a dearth of conclusive data to support limiting its use. Read More
China’s FDA is pledging to impose stronger drug safety regulations, with efforts focused on risk assessments and a risk grading and classification system, as well as initiatives to effectively detect and solve problems. Read More