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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cleared 510(k) device would have 30 days to register the transfer of ownership on an FDA online database, under draft guidance released late last month.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The U.S. Food and Drug Administration released draft guidance late last month clarifying when human cellular and tissue-based products may be regulated solely under section 361 of the Public Health Service Act and 21 CFR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
Clinical laboratory groups plan to mount a major push against the FDA’s efforts to regulate lab-developed tests at a Jan. 8 and 9 public meeting ... Read More
The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable medical devices and diagnostics, but questions remain about the program’s transparency. Read More
EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More
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
India’s Central Drug Standards Control Organization has issued a draft guideline on good manufacturing practices for medical devices and diagnostics — the latest in an effort to increase the quality of medtech products, which are governed loosely under the country’s drug laws. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More
Stryker and its OtisMed subsidiary must ante up more than $80 million for distributing knee replacement surgery cutting guides that had been denied FDA clearance. Parent Stryker will also establish a compliance program to ensure all marketed products have the necessary approvals. Read More
An umbrella group in the EU is recommending that health technology assessment bodies pool sensitivity and specificity data from multiple diagnostic accuracy studies using one of two methods: hierarchical summary receiver operator characteristic or bivariate random-effects techniques. Read More