Dental Impact of 21st Century Cures Act
In December, Congress passed and President Obama signed into law the 21st Century Cures Act. The new law seeks to promote new medical treatments by increasing research money for the National Institutes of Health and streamlining the Food and Drug Administration's review of new drugs and devices.
There are a few provisions which affect the approval and classification of FDA-regulated medical and dental devices. Under the new law, the FDA is required to create an expanded program to expedite the pre-market approval of breakthrough medical devices. To be eligible, a device would have to do one of the following: offer a significant advantage over existing treatments or diagnoses for life-threatening or irreversibly debilitating diseases; represent a breakthrough technology; or address a condition for which no treatment exists. The FDA would have to determine if a device meets the criteria for expedited review within 60 days of receiving a request from a manufacturer.
The new law also requires FDA to publish a list, within 120 days of enactment, of Class I medical devices—often the least-invasive type of device which includes items such as dental exam gloves—that would be exempted from certain safety assurance reporting. A similar list easing assurance requirements for Class II devices—such as a dental ultraviolet activator or airbrush—would be due 90 days after enactment, though would be subject to public comment.
By Patrick Cooney, The Federal Group, Inc.
Legislative Representative, Dental Trade Alliance