FDA’s plan is meant to broaden the test cases for the program to small and large software development companies building a range of SaMD products. The regulator is opening up the program to 510(k) submissions, instead of its initial focus on companies moving through the De Novo regulatory pathway.
The organization launched a pilot of its pre-cert program in 2017 with nine companies: Apple, Fitbit, J&J, Pear Therapeutics, Roche, Phosphorus, Samsung, Tidepool and Verily.
The pre-cert program is meant to provide a different approach to regulating digital health technology in a pathway that is better aligned with the software development cycle.
Instead of approving products in a piecemeal manner, pre-certification program participants would be given a “Excellence Appraisal” which could streamline much of the quality requirements necessary under the traditional regulatory pathway.
Additionally, companies would be required to include a plan to monitor and evaluate real-world performance of the technology.
“No regulator in the world could keep with with the volume of new software being created,” FDA’s digital health lead Bakul Patel said at the MedCity News INVEST conference last month.
“The pre-certification is really taking the oversight in two different directions. One is upstream and understanding where the company is and how excellent they are. Two is how do you move from this concept of quality systems and compliance to excellence?”
While the FDA touts the program as a way to fast-track innovation within the space, not everyone is so convinced.
Skepticism abounds from lawyers and regulatory experts about whether the pre-cert plan can be put into action without additional legislative support to expand the organization’s authorities.
Industry groups have also expressed concern about the disconnect between the US regulatory framework and the risk classification structure established by the International Medical Device Regulators Forum.
Still, being involved with the FDA’s program at an early stage could give companies a leg-up on competitors.
Potential new applicants for the program should be planning to submit a SaMD product for De Novo or 510(k) clearance prior to 2020 and must be in good standing without any outstanding FDA compliance actions.
The prospective companies must also be willing to open access to performance data, collect and share real-world post market data, take part in the Excellence Appraisal process and provide info about the company’s quality management system.
Important to note is that the FDA does not intend to provide precertification for companies during the testing in 2019. Interested companies will be accepted into the program on a rolling basis.
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