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The FDA has announced an end to the alternative summary reporting (ASR) program for medical device manufacturers and will make the data publicly accessible. The ASR program originally launched in [...]

FDA regulation 21 part 822 lays out the process, the rules, and the products that require postmarket surveillance. The process is an active, systematic, scientifically valid method of [...]

Risk management and adverse event reporting protocols for medical device manufacturers have been addressed by a new FDA guidance. Producing and controlling electronic records will be critical to [...]