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The precertification model would apply to med-tech orgs of all sizes.
The FDA has released an updated version of its Software Precertification Model, the next step in its quest to create a functional framework to review and certify software as a medical device (SaMD).
In general, the new version adds more detail to the iteration released in April. Many of the changes are intended to make explicit the agency’s willingness to be flexible, in areas where the first version left organizations wanting more specifics. The document also notes topics for which the FDA desires additional public feedback.
The model may one day enable health-tech organizations to volunteer to enter a fast track to FDA approvals, requiring front-end scrutiny of the company’s practices. The idea is that software moves quickly, and such a program could get meaningful advances to market more quickly. The working model outlines how that would review process might work.
One key change is a rewriting of the classifications between Level 1 and Level 2 precertification. Level 1 is intended for firms that are new or don’t yet have a proven track record, while Level 2 is intended to give a streamlined opportunity for companies with a proven track record.
The new guidelines expand the pool of organizations that could potentially use the faster Level 2 precertification pathway. Whereas previously, a company would need to show that it had successfully marketed and maintained a medical device to get Level 2 status, the new guidelines simply require a company to have marketed and maintained “products.”
The revised document also stresses that the program will be open to organizations of all sizes. The agency said there had been some confusion surrounding that issue in the public comment docket.
“The vision for the program is to be available for any size organization who is currently developing products in healthcare, including medical devices, or has the potential to deliver products that are medical devices,” the new version of the document states.
The document also makes clear that, although the agency seeks to enact uniform standards, it also aims to give organizations options as to how they demonstrate that they meet the standards.
“An organization has flexibility to show how its processes, systems, and measures of performance track to program’s specified elements, performance measures, and ultimately, the excellence principles,” the FDA said.
SaMD is defined as any software that has a medical purpose but can perform these tasks without being part of a piece of hardware. In the revised model, the FDA added language to clarify that elements of the software that don’t meet its definition of a medical device don’t fall within the regulatory scope of the model. For instance, software functions designed to provide administrative support for a healthcare facility aren’t subject to the regulations.
The agency is seeking more public input regarding the list of elements it requires in order to determine safety and effectiveness in pre-market review. Regulators also want feedback on the Real-World Performance Analytics (RWPA) component of the framework.
“Please provide feedback on the comprehensiveness of the product-level RWPA framework, identify any data or analytic domains that you believe are missing, and consider strategies to ensure that data access follows least-burdensome principles,” the agency requested.
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