FDA Announces Precertification Program For Digital Health Tools

The FDA has recruited some the world’s top technology and medical companies to help it pilot test a program under which digital health software could be marketed without going through the through the agency’s entire certification process. The participants, which include Apple, Fitbit, Johnson & Johnson, Samsung and Roche, will give the agency access to the measures they’re using to develop, test and maintain their software, and also how they collect post-market data. Once armed with this information, the FDA will leverage it to determine the key metrics and performance indicators it uses to see if digital health software meets its quality standards. Companies that meet these new standards could become pre-certified, a status which grants them a far easier path to certification than in the past. This represents a broad shift in the FDA’s regulatory philosophy, “looking first at the software developer digital health technology developer, not the product,” according to a report previously released by the agency. If the pilot works as planned, the FDA is considering making some significant changes to the certification process. If their processes pass muster, pre-certified companies may be allowed to submit less information to the FDA than they currently must before marketing a new digital health tool.  The agency is also considering the more radical step of allowing pre-certified companies to avoid submitting a product for premarket review in some cases. (It’s...
Source: EMR and HIPAA - Category: Information Technology Authors: Tags: Digital Health EHR Electronic Health Record Electronic Medical Record EMR Healthcare Healthcare Business Healthcare Devices HealthCare IT mHealth Pharma America Medical Association American Heart Association Apple FDA FDA Cer Source Type: blogs