PhD | Director Therapeutic Innovation and BaseLaunch
Tel. +41 61 295 50 17stephan. emmerth@baselarea. swiss
The U.S. health authority FDA is to pilot a certification program for digital health solutions. The Basel-based pharma giant Roche is among the companies selected to participate in the pilot project. It will give the FDA an insight into its processes.
The FDA intends to revolutionize the certification process for digital health solutions. Its goal is to determine whether a company meets certain software standards and if so, to precertify the company. If the company then applies to certify a product, it will be required to submit fewer documents.
The aim of the project is to accelerate the certification process. The FDA explained that it wants to tap into and foster innovation.
A pilot project is now to trial the process. Of the more than 100 companies that applied to participate in the project, the health authority selected nine that it regards as leaders in the medical device and technology sectors.
As well as giving the FDA access to tests that they use for their software products, the companies have agreed to be available for site visits from FDA staff should the authority need to gather more information.