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11. 12.2017

FDA Medical Device Guidance Documents to be Issued in 2018

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has prioritized guidances for topics including Unique Device Identification, 510(k) premarket notification issues and voluntary consensus standards for its 2018 fiscal year.

CDRH’s announced plans cover “A-list” and “B-list” guidances, and also identify existing guidances the division intends to review over the course of next year. However, CDRH has not typically completed all identified activities in previous years, so stakeholders should not assume that all priorities identified for 2018 will be addressed.

A-list medical device and IVD guidance plans
​​​​​​​CDRH has listed the following higher-priority planned final guidances for 2018:

  • Revised description of classification pathways for new types of medical device accessories
  • Unique Device Identification (UDI) policies for Class I and unclassified device compliance deadlines
  • Appropriate use of voluntary consensus standards for US premarket submissions
  • IVDs that utilize Next Generation Sequencing (NGS), genetic and genomic-based components

    Draft guidances given high priority for 2018 include:

    • Least Burdensome Provisions for FDA compliance policies
    • 510(k) Third Party Review program
    • Using performance criteria to meet Substantial Equivalence requirements under the Abbreviated 510(k) program
    • The FDA Q-Submission (Q-Sub) program
    • Policies for multifunctional medical devices
    • Export certificates

    Of these prospective guidances, those pertaining to the 510(k) abbreviated pathway and third-party reviews should be of particular interest to medical device companies whose products require premarket notification to access the US market. Along with plans for further guidance on how Least Burdensome Provisions should affect FDA’s premarket review of medical devices, these areas of focus suggest that FDA will pursue less onerous registration requirements for manufacturers in 2018.

    Lower-priority device and IVD guidance plans
    Although not all B-list CDRH guidance documents may see full publication in 2018 due to resource constraints, topics identified do indicate which areas will be on the regulator’s radar:

    • Human factors list of high-priority devices
    • Benefit-risk factors to consider and utilize for Substantial Equivalence determinations in 510(k) submissions that have “different technological characteristics”
    • Principles for co-development of IVDs with therapeutic products

    Source: FDA News