Apple, Samsung, Fitbit and a handful of other companies are joining a new pilot program to speed up the approval of healthcare-related apps and services.
On Tuesday, the US Food and Drug Administration (FDA) announced the digital health software precertification pilot program (FDA Pre-cert) during the AdvaMed MedTech Conference in San Jose, California, of which nine major companies will be acting as guinea pigs in the pilot stage.
Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily are the first batch of companies to join the scheme, which the FDA says “will help revolutionize digital health regulation in the US.”
If the new program results in a regulatory framework which speeds up the acceptance of acceptable health-related services, apps, and products, this not only benefits the businesses themselves bringing such ideas to market but consumers themselves.
However, rather than focusing purely on products themselves, the FDA wants to be able to “pre-certify” companies that meet a set of standards for quality.
Once a company is pre-certified, made possible through the FDA’s analysis of software design, maintenance, supply chains and reputation, then they will be able to submit “less information to the FDA than is currently required” to gain approval for products and services.
Every company in the pilot has agreed to provide the FDA with access to development, testing, and maintenance protocols, including how post-market data is gathered.
Apple is the provider of Carekit, Health, and ResearchKit, while Samsung has also tested the waters with the Samsung Health app. Should the scheme go well, both of these tech giants — together with the other companies — could find FDA approval processes sped up, leading to a quicker time to market for new applications and systems.
The FDA says the agency is also considering whether and how precertified companies “may not have to submit a product for premarket review” in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said FDA Commissioner Scott Gottlieb. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
“These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product,” the executive added.
The Pre-cert program was officially launched on 27 July as part of the agency’s Digital Health Innovation Action Plan. Over 100 companies applied to join the pilot program, leading to the selection of nine in total.