FDA announces further plans to hasten digital health R&D
The FDA has announced further details about its plans to hasten development of digital health products and tools.
Pear Therapeutics in 2017 became the first company to get a “digital therapeutic” approved by the FDA, for patients trying to fight addiction to opioid drugs.
The regulator is hoping to encourage further development of digital therapies and apps by using a framework based around pre-certification.
This allows for fast development of apps from manufacturers whose software has been reviewed and approved by the FDA.
In a post on the FDA’s website, the organisation’s commissioner Scott Gottlieb fleshed out the plans for further pilots of the programme this year.
He noted “promise of innovation” from products based on artificial intelligence software, which could alert doctors to a potential stroke, and smart watches that could help identify atrial fibrillation.
The regulations are designed around the need for frequent but fast reviews of digital technology that is often updated.
The pathway is aimed at products that the FDA deems to be of low or medium risk and already outlines quality standards and good manufacturing practices.
New tweaks announced by Gottlieb include a new process known as Excellence Appraisal, which will be used at the very start of development.
By collecting information early in development the FDA aims to further streamline the process by tailoring each filing to a particular digital health device based on the information gathered at the start of the process.
Gottlieb also announced a test plan to validate that the new process will work and can generate the same quality and type of information on safety and effectiveness as current methods.
He also announced a working model based on the new framework, which the FDA will use to further develop the system in the future.
In a separate development Gottlieb said that the FDA has around a month’s worth of funding for new filings, because of the current government shutdown.
The FDA cannot accept the user fees it uses to fund regulatory reviews until the political impasse sparked by president Donald Trump’s demands to fund a border wall with Mexico has been resolved.