The Pre-Cert program represents a new regulatory paradigm for FDA regulating future software as medical device (SaMD). To cope with shorter development cycles and unique opportunities that software products offer (i.e. address malfunctions quickly to reduce adverse events), the FDA intends to certify organizations by their proposed culture of quality and organization excellence (CQOE) and past level of experience with software design, testing, and monitoring. Depending on the type of certification an organization receives and the risk profile of the software, a suitable approach for carrying out premarket review will be determined. This allows the FDA to work with these pre-certified organizations quickly, and effectively addresses software regulatory issues.
Here is what your organization need to know to leverage the Pre-Cert testing program in 2019:
1. Excellence Appraisal: Demonstrate your organization's processes and measures are being used effectively to meet the five excellence principles - Product Quality, Patient Safety, Clinical Responsibility, Cybersecurity Responsibility, and Proactive Culture. Compared to traditional Quality Management Systems, the scope of excellence appraisal also puts emphasis on cybersecurity practices and clinical responsibility. It is recommended by the FDA to leverage Standards and Certifications from 11 Appendix as part of the appraisal, and build the appraisal from the proposed organizational elements from 12 Appendix and SaMD IMDRF N23. The organization should define performance indicator, target time frames, metrics/threshold, with a goal to strive for excellence in manufacturing software products.
For 2019 Testing, FDA intends to conduct Excellent Appraisals with Pilot Organizations, while in the future there would be an option to do the same with Third Party Appraisers. Your organization should anticipate the great opportunity to work with FDA on revising and optimizing the appraisal, especially on elements which has not been addressed heavily before, namely cybersecurity practices and clinical responsibility. FDA would like to leverage this experience and to develop tools, techniques, or processes to further refine appraisal elements with a goal to provide increased precision, accuracy, and confidence in the appraisal methods and demonstration of excellence in product development.
2. Organization Pre-certification: FDA intends to pre-certify organizations who demonstrate the ability in developing, maintaining, and marketing safe and effective SaMD. The FDA have currently proposed two levels of precertification based on an organization's excellence.
Level 1 Pre-cert is designed to allow organizations who have limited or no experience delivering software products but with established organizational elements and strategies in place to deliver and maintain high-quality lower-risk SaMD that are safe and effective.
Level 2 Pre-cert is designed to allow organizations who have extensive experience in delivering software products to suggest a level of assurance to develop safe and effective lower and moderate risk SaMD.
For 2019 Testing, FDA does not intend to establish precertified company, nor levels of precertification during testing in 2019. The precertification levels described here are intended only for exploration and consideration for a future Software Pre-Cert program.
3. Review Determination: Allowing organizations to develop a reasonable risk-based framework and to determine the appropriate premarket review pathway with the FDA collectively. Risk categorization should be determined by SaMD product-level elements listed in Section 5.2 and by following guidance from SaMD IMDRF N12. FDA believes that based on product risk and organization’s level of precertification, the level of review can be determined per Table.4 below. SaMD definition statement which describes the intended medical purpose, and the device description which supports the development of the Indications for Use and Device Description should also be included for the discussion.
For 2019 Testing, FDA recommend that information proposed for review determination should be provided during an optional Pre-Submission meeting or as part of the premarket submission.
The objectives of Testing of Review Determination in 2019 include:
Develop and evaluate a decision tree or support tool for determining if precertified organizations’ SaMD products are regulated and, if so, their applicable risk categorization.
Evaluate proposed risk category framework delineation levels for premarket submission for precertified organizations as input to the proposed level of review for SaMD in a future Software Pre-Cert Program.
Develop and evaluate a framework for how major/minor software changes of SaMD will be reviewed in the Software Pre-Cert Program, beginning with the framework outlined in the guidance Deciding When to Submit a 510(k) for a Software Change to an Existing Device.
Annotation: SR – Streamlined Premarket Review, L1 – Level 1 Pre-Cert, L2 – Level 2 Pre-Cert
This is the Part 1 of a two-part series focusing on FDA's Pre-Cert Working model. Please click here to continue to Part 2.
About the Author
Andrew Wu, Software Consultant at Rook Quality Systems.
"Working at the intersection of project and quality management, I believe better practice in software development and computer system validation can greatly benefit companies who are trying to put their novel medical technology in the hands of providers or patients".