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US FDA says it will look to leverage its increasingly used de novo  pathway as means to move forward with its ambitious Digital Health Software Precertification Program while staying within its existing statutory authorities. This update was included in one of a several documents posted this week to move the pre-cert program forward into a new testing phase after the past year of development.

The pre-cert program is intended as a pathway to a new regulatory paradigm for digital health products, where firms are pre-certified under an appraisal process that assesses a company's culture of "excellence" in developing and evaluating products. As a result, pre-certified firms can benefit from a streamlined pre-market review process for new products. (Also see "Coming Together On Pre-Cert: Digital Health World Engages With FDA To Hash Out Regulatory Future" - Medtech Insight, 6 Feb, 2018.)

FDA was busy in 2018 working with nine pilot participants, including Apple Inc.,Verily Life Sciences LLCSamsung Electronics Co. Ltd.,Johnson & Johnson, and Roche, to establish what must be included in an excellence appraisal and how to leverage it to streamline, or even eliminate, pre-market review of new software.

In the process, the agency received some pushback about whether its plan went beyond its regulatory authorities. (Also see "US FDA's Software Pre-Cert Program: Is The Authority On The Books?" - Medtech Insight, 31 Jul, 2018.) In addition, lawmakers questioned whether the approach would properly protect patient safety. (Also see "US Senators Question FDA's Pre-Cert Program Authority, Concerned About Safety" - Medtech Insight, 10 Oct, 2018.)

FDA's newly announced pre-cert plan for 2019 seems intended to respond to both critiques, while sticking in some manner with its previously announced intention to launch an initial version of the program in 2019.

The agency's Jan. 7 announcement included three new pre-cert program documents: a regulatory framework document, a test plan that lays out the agency's approach to assessing whether the pre-cert model can ensure proper vetting of new products and an update to the agency’s pre-cert "working model" that spells out the program in more detail.

The “Regulatory Framework for Conducting the Pilot Program within Current Authorities” tries to outline how FDA can move forward with testing the program using its current authority instead of seeking additional authority from Congress.

“We believe the most efficient way to test this type of program is to do so within the FDA’s current regulatory authorities,” FDA Commissioner Scott Gottlieb said. “We know many stakeholders have had questions about how this would work.”

The initial stage of the 2019 pilot will be used to understand the regulatory model that can be used and help the agency clarify whether it does in fact require more regulatory authority from Congress.

The agency identified the de novo  pathway as "well-suited to meet the goals of our pre-cert program because it is a pathway for certain novel types of low- to moderate-risk devices to obtain marketing authorization,” Gottlieb explained.

He notes the Quality System Regulation requirements that de novo  application sponsors must follow compliment the type of quality assurances FDA is looking for from sponsors in the pre-cert pilot.

“In the pre-cert model, many of these QSR requirements would be satisfied by information the FDA collected through the excellence appraisal process, which is aimed at evaluating the quality and excellence of the software developer for pre-cert,” Gottlieb noted. “By collecting this information early, the excellence appraisal could be leveraged to streamline a developer’s de novo submission, reducing content the developer would need to submit to the agency under the de novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal.”

According to the “Software Precertification: 2019 Test Plan” document, FDA says it intends perform a parallel review process to compare information that would be available via the pre-cert excellence appraisal and a streamlined de novo  review versus a traditional de novo  submission.

For select "software as a medical device" developers that undergo the excellence appraisal process, sponsors will be instructed to make a traditional pre-market submission for a new product, but FDA will set up two review processes to evaluate the product under the new pre-cert model with information that would have been included in a streamlined submission and one going through the traditional de novo pathway. For product categories that are classified by de novo  route via the pre-cert pilot program, future devices in that category can submit 510(k)s and FDA will assess the excellence appraisals in that context as well, FDA says.  

The agency says the process will not add any additional burdens for sponsors. In addition to the parallel reviews, FDA will also be assessing the approach retrospectively with previously reviewed applications.

“As highlighted in the test plan, this approach will help the FDA show that the combined assurance resulting from the proposed excellence appraisal and streamlined pre-market review submission will provide the same quality and type of information necessary for the FDA’s determination of whether a software developer’s products meet the statutory safety and effectiveness standard, as compared to the FDA’s approach in reviewing these devices under the traditional de novo  review process,” said Gottlieb. “The results and learning from this testing will provide input for refining our pre-cert program as well as confirm the validity of the concept envisioned in the pre-cert framework.”

The commissioner says FDA expects the conclusion of the testing to show, that through testing and refinement, the evidence collected via excellence appraisal and a streamlined pathway meet the agency’s statutory requirements for marketing authorization.

Finally, the latest version of the 58-page pre-cert working model document now incorporates the new regulatory framework and testing plan, in addition to other updates based on stakeholder input.

From the editors of The Gray Sheet


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