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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
Submissions for radiation biodosimetry medical countermeasure devices should include well-controlled analytical studies establishing device performance across the entire range of the device, the FDA says. Read More
Foreign companies seeking to market novel medical technologies in China should have an easier time, thanks to an agreement by Chinese officials to cut regulatory red tape. Read More
Companies assuming possession of a previously cleared 510(k) device would have 30 days to register the transfer of ownership on an FDA online database, under draft guidance released late last month. Read More
The U.S. Food and Drug Administration released draft guidance late last month clarifying when human cellular and tissue-based products may be regulated solely under section 361 of the Public Health Service Act and 21 CFR 1271 and when they are regulated as medical devices, drugs or biologics. Read More