FDA's Roadmap for Guidance Documents 2026
- Date
- December 2, 2025
- Category
US Regulations
- Description
At the end of November, the FDA published a roadmap for planned guidance documents for the current fiscal year 2026. The FDA divides this roadmap into three lists: A-List documents to be published with priority in 2026, B-List guidance documents that the FDA intends to publish depending on resource availability, and the “Under Construction” list, which the FDA intends to further develop for later publication. These lists include topics such as:
A-List:
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Predetermined Change Control Plans for Medical Devices
B-List
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Marketing Submission Recommendations
Medical Devices with Indications Associated with Weight Loss – Premarket Considerations
Content of Human Factors Information in Medical Device Marketing Submissions
Under Construction List
Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling
General/Specific Intended Use
New guidance documents always mean new requirements for manufacturers and distributors, and we are of course here to support you with old and new regulatory challenges as always.