This article is more than 5 years old. Information may no longer be current.
FDA releases final rule on classification, reclassification of medical devices
Click Here to Manage Email Alerts
The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as updates and clarifies the Part 860 regulations without making substantive changes to existing practices for the classification and reclassification of medical devices.
Titled “Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures,” the final rule will be effective starting March 17, 2019.
“FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation,” according to the final rule.
In addition to amending Part 860 of title 21 of the Code of Federal Regulations to conform the applicable provisions governing the classification and reclassification of medical devices to the Federal Food, Drug and Cosmetic Act (FD&C) as modified by the FDA Safety and Innovation Act (FDASIA), the final rule will also incorporate the process for issuing administrative orders by amending the provisions of its regulations governing reclassifications initiated by FDA. According to the final rule, reclassification of a post-amendments device or a transitional device will be initiated by the FDA instead of in response to a petition, and the final rule removes the requirement of a hearing for reclassifying transitional devices.
The final rule states the elimination of some paperwork filing requirements and enhanced consistency and uniformity across reclassification proceedings may reduce the regulatory and economic burden. The decreased time a petition will need to be reviewed for device reclassification may provide further benefits, according to the final rule. Medical device manufacturers and the FDA will both accrue cost savings based on changes made in the final rule.
“We estimate that overall cost savings over the next 10 years to be $0.05 million at a 3% discount rate and $0.04 million at a 7% discount rate,” according to the final rule. “Our estimates of the annualized cost savings are $0.006 million at a 3% discount rate and $0.006 million at a 7% discount rate.”
Reference: