EMERGO SUMMARY OF KEY POINTS:

• The US FDA’s Center for Devices and Radiological Health (CDRH) unit has publicized plans for medical device and IVD guidances over the next year.
• High-priority areas of focus for CDRH in 2018 include 510(k) third-party reviews and abbreviated pathways, Unique Device Identification (UDI) deadlines for low-risk devices and device accessory classification.
• Not all planned CDRH guidance documents will be published due to resource allocation and other regulatory obligations.

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

Emergo will provide further analysis of these upcoming guidance documents and their implications for US market registrants as they are published.

Additional FDA medical device regulatory information:

• US FDA 510(k) consulting for medical device and IVD companies
• FDA UDI consulting and support for medical device companies
• FDA Q-Submission (Q-Sub) support
• Human Factors Engineering (HFE) and usability testing for medical devices