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The FDA released guidance for sponsors of devices with cybersecurity risks on what they should include in their premarket submissions, as well as considerations for device design and labeling. Read More
To obtain a free sale certificate, manufacturers must submit a hard copy cover letter including the list of products the certificate will cover. 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
According to AdvaMed, an online medical device labeling database poses numerous problems, “including risk to patient safety due to the frequency at which patient labeling may be updated.” Read More