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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 hit three foreign device manufacturers with warning letters, calling the firms out for quality system violations that led to adulterated products. 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