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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
The FDA and the Department of Homeland Security signed a memorandum of agreement that expands their collaboration for medical device cybersecurity. Read More
Three Democratic senators raised concerns about the FDA’s digital health pre-certification program and called for more details from the agency. Read More
To give a reasonable assurance of safety and efficacy of high flow humidified oxygen delivery devices, the FDA reclassified them into Class II and identified special controls. Read More
The FDA issued a final order reclassifying the active implantable bone conduction hearing system as a Class II device with certain special controls. Read More
The FDA flagged cybersecurity vulnerabilities in two implantable cardiac device programmers manufactured by Medtronic and approved a software update that will allow providers to continue using the programmers without connecting to the internet. Read More
Distributors and importers that assume the obligations of device manufacturers also assume responsibility for unique device identification labeling, the European Commission said. Read More