Fitbit is One Step Closer to Being a Health CompanyNov 12, 2017
In September, the U.S. Food and Drug Administration (FDA) announced that fitness tracker manufacturer Fitbit (NYSE:FIT) and eight other companies would be part of a new digital health software precertification pilot program aimed at fostering innovation and streamlining the process of getting regulated products to market. This could be good news for Fitbit. Let’s take a look at why.
Partnering with the tech industry to design a robust precertification process is a new approach that will certify a company rather than the FDA reviewing each individual product. The idea is that companies that meet certain criteria could release software-as-a-medical-device (SaMD) products with an accelerated review process or directly to market depending on the risk of the product.
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