The United States Food and Drug Administration announced today a new pilot program designed to help Apple and other technology companies develop new digital health accessories faster while maintaining some government oversight.
According to Bloomberg, the agency said it had selected nine major tech companies for the pilot program that may let them avoid some regulations that have tied up developers working on health software and products.
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” FDA Commissioner Dr. Scott Gottlieb said in a statement. The program would let the agency inspect companies’ facilities to ensure they meet quality standards and can adequately track their products once they’re on the market.
Dr. Gottlieb added:
Our method for regulating digital health products must recognize the unique and iterative characteristics of these products. 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.”
“If they pass the agency’s audits, the companies would be pre-certified and may face a less stringent approval process or not have to go through FDA approval at all,” reads the article.
FDA’s standard approval process can take months so clearly that’s good news for Apple. Samsung and Fitbit were also selected to participate in FDA’s new pilot program.