FDA Online Tracker Now Accepting Premarket Submissions
The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.
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RQM’s Allison Komiyama and Kevin Go summarized up the year’s changes to digital health regulation and outlined what to expect in the coming year.
FDA Preps Device Makers To Use eSTAR For De Novo Requests
Manufacturers can’t use the US FDA’s voluntary eSTAR product submission program for de novo requests until January – but they can start practicing now on how to use eSTAR for that review pathway.
News We’re Watching – US FDA Updates, Digital Therapeutics Legislation, AI Endoscopies, Monkeypox EUA, And New AdvaMed Chair
The US Food and Drug Administration recently issued updates regarding improvements to its online submissions portal, enhancements to its electronic medical device reporting system, pediatric X-ray guidance, expanded indications for a popular breathing device, and mammogram guidelines; and more news we’re watching.