FDA


'FDA' Articles

Apple Joins FDA Pilot Program for Faster Approval of Digital Health Tools

The Food and Drug Administration today announced that it has selected nine companies to join its voluntary Pre-Cert pilot program, which is designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products. Companies accepted to the program include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool, and Verily. With its program, the FDA is aiming to create a more tailored approach toward digital health technology by looking at the software developer rather than the product to establish a firm-based pre-certification program for these digital health tools. The companies accepted to the program will be reviewed for software design, validation, and maintenance and to determine if they meet the FDA's quality standards for pre-certification. Companies who have been pre-certified may be able to submit less information to the FDA before marketing a new digital health tool, speeding up the approval of new services and technologies. The FDA is also considering allowing pre-certified companies to avoid submitting products for premarket review in some situations. As part of the program, Apple will provide the FDA with access to the measures it use to develop, test, and maintain software products. Apple has agreed to allow visits from FDA staff and offer information about its quality management system."Our method for regulating digital health products must recognize the unique and iterative characteristics of these

FDA Taking 'Almost Hands-Off Approach' to Regulating Apple Watch and Similar Wearables

As Apple and other companies create products capable of providing more and more detailed health-related information, the U.S. Food and Drug Administration has decided to give the companies creating these devices breathing room to manufacture the devices free, for the most part, from the scrutiny of the agency (via Bloomberg Business). The FDA's associate director for digital health, Bakul Patel, noted that while the agency will be more lenient on devices aimed at simply improving the lifestyle of its customers, more health-invasive features, like a glucose monitor app on the Apple Watch, will continue to be reviewed by the FDA. "We are taking a very light touch, an almost hands-off approach," Patel, the FDA's associate director for digital health, said in an interview. "If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in." The rule of thumb released in a few guidelines by the agency highlight that the FDA's focus will be on devices and software that are attempting to replicate, or mimic, the functionality of a medical service or device. Basic heart-rate and step-counting aspects of these wrist-worn devices will receive little-to-no regulation from the FDA. Marketing will also be a factor for the agency, according to Patel. If a company is attempting to promote a product as being able to assist doctors in making medical decisions, "it will require more oversight." This is a concern not aimed currently at Apple's own Apple Watch and HealthKit, due to both's minimally invasive health-related