The U.S. Food and Drug Administration has released draft guidance outlining the agency's new position that hardware and software products that store or transfer medical data and images are 'low risk' and therefore do not need FDA regulation.
Three years ago, the agency felt differently — medical device data systems were Class III, or high-risk, subject to heavy FDA scrutiny. In February 2011, these products were downgraded to Class I and now the FDA says it does not intend to enforce any regulatory controls on these products.
The FDA's new stance is the result of its ongoing collaboration with ONC, HHS and the Federal Communications Commission. The agencies have been working together to re-establish a risk-based regulatory framework to strike the most appropriate balance between protecting patient safety and fostering innovation.
"In light of those discussions [with HHS, ONC and the FCC], we believe that medical device data system products pose little risk," wrote Bakul Patel, senior policy advisor at the FDA, in a blog post explaining the new draft guidance.
"Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems," he wrote.
More Articles on the FDA:
5 Things to Know About HealthKit
Apple's HealthKit Likely to Avoid FDA Regulation
DA: Risk Information Must Be Part of Pharma, Device Companies' 140-Character Tweets