What Digital Health companies can expect from the FDA in 2020

FDA regulations do not provide a full, prescriptive manual for managing products in a regulated environment. For certain cases the FDA will elaborate by providing non-binding guidance documents with further details on how to interpret and apply regulations.

The FDA has announced their commitment to providing guidance on the following topics in the FY 2020.

The original full list separated into top and second tier priorities can be found HERE.

• Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
• 510(k) Third Party Review Program
• Safer Technologies Program for Medical Devices
• Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices
• Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments
• The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
• Recognition and Withdrawal of Voluntary Consensus Standards
• Clinical Decision Support Software
• Multiple Function Device Products: Policy and Considerations
• Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

Draft Guidance Topics

• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• Distinguishing between Medical Device Servicing and Remanufacturing
• Computer Software Assurance for Manufacturing, Operations, and Quality System Software
• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act (revision)
• Unique Device Identification: Policy on Enforcement of GUDID Submission Requirements for Certain Class I Devices
• Pragmatic Generation of Validity Evidence for Patient-Reported Outcome Measures Used in Medical Device Submissions
• Device-Specific Criteria Guidance(s) for Safety and Performance Based Pathway Implementation

If you have questions about how to apply these guidances within your company contact us at info@enzyme.com