Proposed FDA Precertification Program Streamlines Review Process and Brings SaMD to Market Faster


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Jennifer Csik Hutchens and LaKeshia Banks
Robinson Bradshaw Publication
June 18, 2018

The U.S. Food & Drug Administration recently released an initial working model for its Software Precertification Program. The FDA proposed the precertification program to create a more efficient process for vetting and approving medical software and device developments, specifically for developers of Software as a Medical Device (SaMD). The model should appeal to mobile app developers, medical imaging software companies, technology startup companies, existing medical device manufacturers and electronic companies seeking to enter the medical device arena.

The FDA defines medical devices as any instrument, machine, software or apparatus used to monitor, cure, prevent, diagnose or treat a disease or otherwise have an impact on the function of the body. SaMD is defined by the International Medical Device Regulators Forum as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” SaMD ranges from apps that allow a smartphone to display MRI images for diagnostic purposes to smart device microphones that detect interrupted breathing during sleep, data that predicts risk for developing a stroke or heart disease, and detection software used for colorectal cancer.

The model is based on a pilot program that was conducted in September 2017 with nine companies: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. The pilot program allowed the FDA to gather information about how the companies operate, how they measure and ensure quality products, and how they might be allowed bypass the standard certification process. Based on the FDA timeline, the pilot is ending this fall and the first version of the program is anticipated to launch in December of this year.

The FDA’s goal is to design a program that would allow a precertified company to bring medical software devices to market faster. The FDA acknowledged that the traditional process for reviewing medical devices may no longer be suitable due to changes in technology and advances in software, which are generally occurring at a much quicker pace than with respect to hardware. The FDA currently regulates medical devices according to their novelty and the level of risk that they pose. The burden on the device’s proponent can range from doing nothing (in the case of exempt devices) to demonstrating that the device is substantially equivalent to an existing device (premarket notification) to the submission of clinical data, as with a drug (premarket approval). At the higher levels of scrutiny, the pre-approval delays can be substantial.

Under the initial model, companies (not the individual devices) are precertified and their classification will assist in determining whether a premarket review for the device is needed. The model is a voluntary program that lays out the systems for classifying companies and SaMDs and the evaluation process, including the need to submit post-market data. The model requires companies to initially meet the FDA’s five “excellence principles”: patient safety, product quality, clinical responsibility, cybersecurity responsibility and proactive culture. Upon meeting the principles, companies are classified into either of two levels based on their experience with delivering a SaMD to market and particular SaMDs are classified into risk categories based on the status of the health care condition that they are intended for. Once these classifications are made, the FDA decides whether the proposed SaMD is a new device or a modification to an existing device, in order to determine the appropriate premarket review process. Companies receive either a premarket exemption in which no review is required or a streamlined review, which is more efficient than the standard premarket process. The model is currently only applicable to SaMD products and to date the FDA has not made any changes to the standard pre-market review process for hardware.

The comment period for the program and working model closed on May 31, 2018. This information will be integrated into the review process, prior to finalizing the precertification program. The FDA is also evaluating if the program will be implemented under their existing authority or if new statutory authority will be needed.

This article was prepared with the assistance of LaKeshia Banks, a rising 3L student at North Carolina Central University School of Law.

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