https://www.raps.org/news-and-articles/news-articles/2021/11/fda-issues-draft-guidance-for-device-software-in-p
FDA has updated the documentation required for sponsors with devices that include software that meets the above specifications. The agency will now consider...
draft guidancedevice softwarefdaissuespremarket
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-use-clinical-data-premarket-notification-510k-submissions
This guidance provides information for situations when clinical data may be necessary to demonstrate substantial equivalence in a 510(k) submission.
clinical datapremarket notificationrecommendationsuse
https://posit.co/blog/webr-fda-pilot/
Submissions of clinical trial data using Shiny and webR are currently being piloted by cross-industry statistical programmers and open-source software...
pharmapioneeringwebassemblywebrshiny
https://www.fda.gov/about-fda/cdrh-reports/sop-decision-authority-additional-or-changed-data-needs-premarket-submissions
The purpose of this document is to define the appropriate decision level for making additions or changes in data requirements from what was requested for...
sopdecisionauthorityadditionalchanged
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-and-refunds-premarket-notification-submissions-510ks
This guidance identifies the types of 510(k)s subject to user fees, exceptions to user fees, and the actions that may result in user fee refunds.
user feespremarket notificationrefundssubmissions