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The FDA issued separate draft guidances on blood glucose monitors used in health care settings and on over-the-counter products used in the home. When finalized, they will replace guidances the agency issued in 2016. Read More
The FDA has withdrawn a proposed rule that would have required manufacturers to submit labels and package inserts in electronic format for certain home-use medical devices. Read More
The FDA plans to continue building out its National Evaluation System for health Technology (NEST) and it is increasing its focus on device therapies unique to women, Commissioner Scott Gottlieb and CDRH Director Jeff Shuren said in a joint announcement. Read More
The FDA is seeking public comment on how it should regulate prescription drug software apps and says some software applications might have to be regulated as a device — such as a software program that uses advanced algorithms to scan skin lesions for evidence of cancer. Read More
The FDA posted an update on its Accreditation Scheme for Conformity Assessment (ASCA) pilot, which aims to streamline conformity assessments for medical device submissions that meet yet-to-be-announced standards. Read More
The FDA said it will allow device manufacturers of Class I and unclassified devices another two years to comply with its unique device identification system requirements, which are being phased in over seven years. Read More