Fitbit is One Step Closer to Being a Health Company

Nov 12, 2017
Fitbit is One Step Closer to Being a Health Company

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.

Continue reading at: https://www.fool.com/investing/2017/11/09/fitbit-is-one-step-closer-to-being-a-health-compan.aspx