CDRH has announced the 2018 Medical Device Guidances the agency intends to publish throughout the upcoming fiscal year. The lists include an “A-list” of final rule and draft guidances the agency plans to publish; a “B-List,” which maintains medical device guidances the agency will publish with time and resources permitting; and a list of previously issued final guidance documents the agency will review retrospectively. While CDRH may not complete the medical device guidances identified, the lists provide manufacturers insight as to the agency’s priorities. This information will be particularly meaningful to you if you are planning on submitting a device for US clearance in 2018.
A-list of Final Medical Device Guidances
- Revisions to the classification pathways for medical device accessories
- Unique Device Identification (UDI) policy regarding Class I and Unclassified Devices
- Use of voluntary consensus standards in premarket submissions
- Considerations for IVDs using Next Generation Sequencing (NGS)
- Use of public databases to support clinical validity of IVDs
A-List of Draft Guidance Topics
- Policies related to multifunctional device products
- Least burdensome provisions for FDA compliance
- FDA 510(k) Third Party Review program
- FDA Q-Submission program
- Using performance criteria to demonstrate substantial equivalence under Abbreviated 510(k)
- Policies for the recognition and/or withdrawal of voluntary consensus standards
- Export Certificates for medical devices
- Validation of automated process equipment software
By reviewing the topics FDA is focusing on, we can make the assumption that the agency working toward streamlining the pathway to commercialization. The use of performance criteria and least burdensome provisions for FDA compliance may help you bring your product to market faster and more affordably.
B-list of Final Medical Device Guidances
- List of high priority devices for Human Factors
- Benefit-risk factors to consider when determining substantial equivalence in 510(k) submissions with different technological characteristics
- Principles for co-development of In Vitro Diagnostic devices with therapeutic product
In addition to the medical device guidances identified as A-list, history has taught us that the FDA will also pay close attention to the topics on the B-list. As additional information related to these topics becomes available, we will keep you informed.