New FDA Guidance Plans for 2025

On October 10, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) published its annual list of guidance document priorities for the upcoming 2025 fiscal year. It looks like 2025 will be another eventful year for the Life Sciences industry.

A-List: Identifies the priority guidance documents CDRH intends to publish during FY 2025

Final Guidance Topics

• 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review (revision)

  
  

• Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency

  
  

• Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff

  
  

• Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564

  
  

• Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls 

  
  

• Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

  
  

• Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act

  
  

• Registration Fee Waiver for Certain Small Businesses Undergoing Financial Hardship 

  
  

• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (revision)

  
  

• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)

  
  

• Validation of Diagnostic Tests for Emerging Pathogens following a Declaration and Determination under Section 564 

  
  

Draft Guidance Topics

• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management Considerations and Pre-market Submission Recommendations

  
  

• Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs: Frequently Asked Question

  
  

• Enforcement Discretion Policy for Premarket and Other Requirements for NIOSH-Approved Air Purifying Respirators

  
  

• Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies (revision of Evaluation of Sex-Specific Data in Medical Device Clinical Studies)

  
  

• In Vitro Diagnostics: Labeling

  
  

• Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (revision)

  
  

• Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (revision)

  
  

B-List: Identifies the guidance documents CDRH intends to publish as resources permit during FY 2025

Final Guidance Topics

• Computer Software Assurance for Production and Quality System Software

  
  

Draft Guidance Topics

• Policy for Regulatory Status of Device Software Functions (revision of Policy for Device Software Functions and Mobile Medical Applications)

  
  

Under Construction List: Identifies guidance documents that CDRH intends to develop as resources permit and that are not on the A- or B-list

Final Guidance Topics

• Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (revision)

  
  

• Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations

  
  

• Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (revision)

  
  

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

  
  

• Evidentiary Expectations for 510(k) Implant Devices

  
  

• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions

  
  

Draft Guidance Topics

• 3D Printing Medical Devices at the Point of Care

  
  

• Clinical Evidence Considerations for Digital Mental Health Treatment Devices, including Computerized Behavioral Therapy Devices

  
  

• General/Specific Intended Use (revision)

  
  

• Substantial Equivalence with Limitations: 510(k) Devices (revision of "Determination of Intended Use for 510(k) Devices")

  
  

If you need any assistance with these topics, or if you would like guidance with respect to any other Quality or Regulatory Compliance matters for your devices or pharmaceuticals, please contact us at PRP. We understand how challenging it can be to maintain compliance while managing your day-to-day operations. We have a large, experienced team of Med Device/Pharma QA/RA consultants throughout the country who can seamlessly integrate with your team to fill any gaps in expertise or bandwidth, ensuring you stay on track with your compliance goals. We would welcome the opportunity to work together!