Recently, the FDA announced a list of tech companies selected to take part in a digital health software pre-certification pilot program (FDA Pre-cert). The program is a new way for the FDA to be able, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify the company.
“The FDA’s Pre-cert pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product.” (Caccomo et al. 2017)
Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,–U.S. FDA Commissioner, Dr. Gottlieb.
- Apple, Cupertino, California
- Fitbit, San Francisco, California
- Johnson & Johnson, New Brunswick, New Jersey
- Pear Therapeutics, Boston, Massachusetts
- Phosphorus, New York, New York
- Roche, Basel, Switzerland
- Samsung, Seoul, South Korea
- Tidepool, Palo Alto, California
- Verily, Mountain View, California
The development of this program by the FDA, is to foster in a new era of digital technology managed healthcare, and continuing to study innovative ways to improve the way government agencies provide and promote better public health initiatives.
“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.”–U.S. FDA Commissioner, Dr. Gottlieb.
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