Digital-Health-FDA-

FDA outlines digital health plan

The FDA has released a statement regarding plans that help regulate digital health technologies.

FDA commissioner Scott Gottlieb announced that the organisation is working on the Digital Health Innovation Plan which “is focused on fostering innovation at the intersection of medicine and digital health technology.”

The plan will involve the FDA making sure it has the right policies in place to promote safe and effective technologies as well the adoption of sufficient regulation that aids the development of innovations. The plan will also include ideas on post-market digital medical devices that enables the FDA to effectively regulate these technologies.

In his post Gottlieb wrote that the plan will ‘help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to develop products that can benefit people’s lives”.

To help streamline the process for digital technologies getting to market, the FDA intends to have policies that are clear enough so developers can easily apply. In doing so the FDA will avoid a case-by-case basis in which it must state its position on individual technologies or software.

To do this the FDA is preparing to implement its policies alongside the 21st Century Cures Act, which states that certain digital health technologies fall outside of FDA regulation. Writing in his post Gottlieb said:

“The FDA, is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies.”

The news comes after the FDA announced earlier this year that is developing a unit focused on digital health. The unit will be placed within Centre for Devices and Radiological Health (CDRH) and will assist with the organisation’s review process of software within the medical device sector.



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