FDA’s Final Guidance Priorities for 2017

On December 23, 2016, the FDA’s Center for Devices and Radiological Health (CDRH) issued a list of 12 final guidance documents and four draft guidances that the agency intends to publish in the next year.

The agency also provided a website where you can comment on the lists. Click here.

During negotiations on the Medical Device User Fee Amendments of 2012 (MDUFA III), the FDA agreed to post a list of priority medical device guidance documents that the agency intends to publish within 12 months of the date this list is published each fiscal year (the “A-list”) and post a list of device guidance documents that the agency intends to publish, as the agency’s guidance-development resources permit each fiscal year (the “B-list”).

2017 Guidance Document Priorities

According to RAPS, the Regulatory Affairs Professional Society, prioritized medical device guidance documents that the agency intends to publish in FY 2017 (“A-list”) included the following Final Guidance Topics.

1. Postmarket Management of Cybersecurity in Medical Devices
2. Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types
3. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
4. Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions
5. Suggested Format for Developing and Responding to Deficiencies
6. Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics
7. Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases
8. Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS) – Based In Vitro Diagnostics
9. Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers
10. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
11. 510(k) Third Party Review Program
12. New or revised procedural guidances for MDUFA IV implementation

Click here to review the entire list.

Make Your Comments

The agency wants to hear your comments on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders.

All submissions received must include the Docket No. FDA-2012-N-1021 for “Medical Device User Fee and Modernization Act”. Submit either electronic or written comments by February 21, 2017 to the link provided at the beginning of this article.