Wednesday, 27 September 2017 : The Food and Drug Administration has announced the names of nine companies participating in a pilot program that could let them pre-clear products instead of going through the agency’s traditional application process.
The program, called Pre-cert, will include Apple, Fitbit, Samsung, Alphabet-owned Verily, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, and Tidepool. The program had attracted over 100 interested companies, and the FDA made its selections based on factors like company size and risk profile of the product(s).
The FDA’s usual timeline for approving new products can often take months, which can delay developers as tech advances faster than the agency can approve it. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” said FDA commissioner Scott Gottlieb. “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 Pre-cert program was initially launched on July 27th. The companies that participate must provide access to the methods they use to develop, test, and maintain their products as well as give information to the FDA about how they collect data and maintain quality.
Direct-to-consumer health products have faced multiple roadblocks in the past as the FDA tries to keep up with how to regulate unknown territories. DNA testing service 23andMe was ordered to halt sales of its at-home kit in 2013, and was approved earlier this year to detect genes linked to certain medical conditions. It wasn’t until 2016 that the agency outlined recommendations for how manufacturers should tackle cybersecurity in devices, and that guidance took more than a year to create.
With growing consumer demand for advanced health tech — the Apple Watch claims to be to detect heart irregularities, for example, and Google recently bought Senosis Health, a startup that turns smartphones into medical devices — the Pre-cert program could help bring new tech health products to market faster while still providing government oversight.
Source : Internet