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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
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. 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
San Antonio, Texas, contract manufacturer Voss Plastics received a 10-citation warning letter for serious lapses in good manufacturing practices and lack of written procedures for adverse event reporting. Read More
The FDA last week green-lighted a new test for coronary heart disease, saying it could be especially helpful in detecting the condition in African-American women. Read More
The Indian government appears poised to expand foreign direct investment by medtech companies as it searches for ways to beef up domestic manufacturing. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for devices, following a recent decision not to pursue a joint regulatory authority with Australia. Read More
Proof that a diagnostic test could be safely performed by untrained workers convinced the FDA to grant a first-ever regulatory waiver for a syphilis rapid screening assay. 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
Medical imaging maker Volcano was plucked up by Royal Philips for $1.2 billion, just days after Wall Street analysts predicted a rocky year ahead for the San Diego, Calif., devicemaker. Read More