A Future Regulatory Paradigm with Potential Broader Implications

May 29, 2018By Véronique Li * —

Since our last post on Digital Health, FDA has continued their public campaign to raise awareness and seek input on the Software Precertification (Pre-Cert) Program. This blog post covers topics that don’t affect only software companies. While the focus is on software, the potential implications are much broader.  For example, in a recently released document, FDA asked for feedback on the precertification process, from where data could be leveraged so that FDA could adopt a risk-based, streamlined approach to Software as a Medical Device (SaMD) review that could replace the need for a premarket submission or allow for a streamlined premarket review for higher risk products.  Such a program could ultimately affect other 510(k)s as well.

In addition to a draft guidance entitled “Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff” which we blogged about here, FDA spoke about Digital Health several times at the Food and Drug Law Institute (FDLI) Annual Conference, held on May 3 and 4, 2018. During one of these sessions, the concept of a streamlined review of software-based medical devices taking 5 – 10 days was floated. FDA acknowledged Digital Health, with its faster, iterative design and development, is not well suited for the current regulatory paradigm. (The same holds true in other areas, such as diagnostic devices using next generation sequencing.) For instance, software-based technologies are regularly updated to fix bugs and provide enhancements to drive further innovation in response to real world performance and user feedback. Unlike most traditional medical device products, Digital Health has the potential to offer real-time learning through real world performance data (e.g., real world health data, user experience data, and product performance data) that can be used to further monitor performance and enable improvements.

Then, on May 10, 2018, FDA held an online interactive user session, led by Associate Director for Digital Health at CDRH, Bakul Patel, to share a program update and answer attendee questions. The session walked through an action plan to align with the 21st Century Cures Act and discussed a working model of a new regulatory paradigm designed to keep up with the quicker software design cycle. The working model identified the areas FDA is interested in developing through their Pre-Cert program through the challenge questions FDA posed. There are over 50 challenge questions, ranging from specific to the excellence appraisal models and precertification status to review pathway determination, streamlined premarket review process, and real world performance.

FDA correctly recognizes that organizations seeking precertification will have different levels of maturity. Accordingly, FDA is proposing two levels: Level 1 is awarded to an organization who has demonstrated capabilities in all five excellence principles but lacks a record in marketing and maintaining medical devices; Level 2 is awarded to an organization who has both demonstrated excellence and has a demonstrated track record.

The Agency also wants to refine the SaMD International Medical Device Regulators Forum (IMDRF) Risk framework for application in the Pre-Cert Program. This framework is designed to facilitate harmonized risk categorization of SaMD based on intended use where IMDRF type has been introduced as I to IV and subtype is 1 to 9 and is illustrated below:

State of Healthcare situation or conditionSignificance of information provided by SaMD to healthcare decision
Treat or diagnoseDrive clinical managementInform clinical management
CriticalIV (9)III (7)II (4)
SeriousIII (8)II (6)I (2)
Non-seriousII (5)I (3)I (1)

Based on current thinking, FDA laid out the following table to describe when the precertification of organizations and commitment to leverage real world performance replaces the need for a premarket submission (No Review) or allows for streamlined premarket review (SR), based on the Pre-Cert level of organization: 

IMDRF Risk CategorizationLevel of Review for Level 1 and Level 2 Precertified Organizations’ SaMD
TypeSubtypeDescriptionInitial ProductMajor ChangesMinor Changes
Type IV(9)Critical x diagnose/treatSRSRNo Review
Type III(8)Critical x driveSRL1 – SR

L2 – No Review

No Review
Type III(7)Serious x diagnose/treatSRL1 – SR

L2 – No Review

No Review
Type II(6)Serious x driveL1 – SR

L2 – No Review

L1 – SR

L2 – No Review

No Review
Type II(5)Non-serious x diagnose/treatL1 – SR

L2 – No Review

No ReviewNo Review
Type II(4)Critical x informL1 – SR

L2 – No Review

No ReviewNo Review
Type I(3)Non-serious x driveNo ReviewNo ReviewNo Review
Type I(2)Serious x informNo ReviewNo ReviewNo Review
Type I(1)Non-serious x informNo ReviewNo ReviewNo Review

Naturally, such a complicated table will present challenges in implementation, but it provides a valuable framework for analyzing the key questions. These coordinated  efforts to share a Multiple Function Device Products draft guidance, working model, challenge questions, and roadmap, in addition to holding in person and online sessions, demonstrate FDA’s commitment to be transparent and build collaboratively. Interested individuals should provide feedback and help drive the next steps for the program either via questions to FDAPre-CertPilot@fda.hhs.gov, comments to the working model, and/or comments to the draft guidance.

* Senior Medical Device Regulation Expert

Categories: Medical Devices