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Beginning Jan. 26, labelers of implantable, life-supporting and life-sustaining devices that are not Class III can register with the FDA’s Global Unique Device Identification Database. Labelers of all other Class II devices are to request GUDID accounts later in 2015, the agency said. 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