An app by SoftwareCPR (http://softwarecpr.com) that provides an easy way to browse and navigate through all FDA Code of Federal Regulations (CFR) related to medical devices, such as:
21 CFR 801: Labeling
21 CFR 803: Medical Device Reporting
21 CFR 806: Medical Devices; Reports of Corrections and Removals
21 CFR 820: Quality System Regulation
21 CFR Part 11: Electronic Records; Electronic Signatures
And FDA Guidance Documents:
General Principals of Software Validation
Content of Premarket Submissions for Software Contained in Medical Devices
Content of Premarket Submission for Management of Cybersecurity in Medical Devices
Regulations can be expanded/collapsed for easy offline reading and navigation. Requires no special permissions and contains no ads! Need help with interpretation or implementation? Submit an email from within the app to receive quick help from expert consultants.
Guidance documents will continue to be added!