In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting innovation by partnering with industry. Consistent with that, and furthering the agency’s emphasis on digital health innovation, he announced the companies that will be participating in FDA’s Pre-Cert program, a program that the agency describes as “intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product.”
Put another way, FDA would examine the company’s software development, testing, operation, and maintenance practices to determine whether they are sufficiently robust to allow the company to be pre-certified. By doing this, the agency hopes to determine key metrics and performance indicators to establish a broader process by which a pre-certified company may be able to market new products while submitting less information for agency review. The companies chosen are Apple, FitBit, Samsung, Johnson & Johnson, Phosphorus, Roche, Samsung, Tidepool, and Verily.
This announcement is one more in a steady drum beat of digital health news that Commissioner Gottlieb has made over the last few months. In case you’re just getting up to speed, here are the highlights:
- June 15, 2017 – Commissioner Gottlieb announces via blog post that a Digital Health Innovation Action Plan is forthcoming, designed to promote innovation in the digital health field and help consumers make more informed health decisions.
- July 27, 2017 – FDA releases its Digital Health Innovation Action Plan, which includes the Pre-Cert program. It also discusses implementation of the 21st Century Cures Act, including issuance of a number of guidance documents regarding medical applications and medical device data systems, clinical decision support software guidance, multi-functionality guidance, and guidances relating to software changes to an existing device and software as a medical device (clinical evaluation). The agency also hosted a webinar regarding Pre-Cert, available here.
In addition to these upcoming guidance releases, Commissioner Gottlieb noted in his AdvaMed address that the agency will be hosting phone conferences prior to hosting a public meeting in January. We will be watching and reporting as FDA’s streamlined approach toward digital health unfolds.