TheFood and Drug Administrationis proposing to pre-certify vendors of the certain software medical device like Software as a Medical Device, including various mobile apps, allowing the companies to skip the agency’s much more rigorous pre-market approval process for hardware-basedmedical devices.
The proposed voluntary program is for review of “software-as-a-medical-device” products, orSaMD– software that is “intended to treat, diagnose, cure, mitigate or prevent disease or other conditions.” Today, such software faces the same regulatory review as medical device hardware.
Examples ofSaMDrange from software that allows a smartphone to view images obtained from an MRI for diagnostic purposes to computer-aided detection software used to help detect breast cancer.
TheFDAsays its current regulation of medical device hardware “is not well-suited for the faster, iterative design, development, and type ofvalidationused forSaMD,” according to the agency’s draft“working model”document spelling out its proposals.
The FDA initially announced plans for the Software Medical Device vendorpre-certificationprogramin2017.
Last September, it selected nine technology companies to participate in apilottohelp develop the program: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.
The pre-certification program is a component of FDA’s Digital Health Innovation Action Plan to “modernization to the regulation of digital health,” the agency said in a statement issued Thursday.