The working model offers the FDA's current proposed framework and vision for the Pre-Cert program, which is aimed at providing more efficient and streamlined oversight over medical device software products. It outlines the program's key components: excellence appraisal and determining precertification level, review pathway determination, streamlined premarket review process, and monitoring of real-world performance, according to the FDA.
New additions to the model include proposals for revised levels of precertification for companies, proposed elements for a company to demonstrate excellence, and an updated description of the appraisal process. The model also provides further details on how the FDA might leverage the International Medical Device Regulators Forum's risk-categorization framework to enable precertified companies to determine the premarket review pathway for their products.
In addition, the model clarifies proposed expectations for precertified companies and discuses possible approaches for putting products through an FDA-streamlined review process. The FDA also proposes types of real-world analytics that precertified companies would be expected to monitor after their product is on the market.
The working model can be found on the FDA's website, and specific challenge questions are also available. Public input on the working model will help inform the launch of the first version of the software precertification program -- PreCert 1.0 -- by the end of 2018, according to the FDA.
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