Dive Brief:
- FDA will have an easier time reclassifying certain devices and requiring premarket approval applications for preamendments to Class III devices after finalizing a rule Thursday.
- The changes are aimed at establishing reclassification processes that can be completed through administrative orders rather than rulemaking. The final rule’s provisions take effect on March 17, 2019.
- The agency appears to have backed off from an effort to amend device definitions after industry submitted comments panning the plan put forward in the proposed rule. AdvaMed and the Medical Device Manufacturers Association argued the proposed revisions to the Class III definition could shift more devices into the high-risk category.
Dive Insight:
While FDA is stepping back from its plan to amend device definitions after industry pushback, its recent De Novo proposed rule will be a vehicle to again consider future changes.
“Based on feedback on the proposed rule, we decided not to finalize the proposed definitions as they would not add clarity or transparency to stakeholders’ understanding of the medical device classification procedures. But in the De Novo proposed rule we are re-proposing definitions of the different classes that are in harmony with the definitions in the FD&C Act,” an FDA spokesperson told MedTech Dive.
The changes rolled out by FDA in the final rule are part of the implementation of the FDA Safety and Innovation Act (FDASIA), which directed the agency to modify how devices are classified and reclassified.
“FDA believes this rule will assist the agency with efficient enforcement of the FD&C Act because it provides increased clarity, uniformity, and predictability for stakeholders, particularly regulated entities, regarding the procedural framework for reclassifying medical devices and calling for PMAs,” FDA said in statement.
The final rule also strikes the requirement to fill out the General Device Classification Questionnaire and Supplemental Data Sheet “because the agency no longer finds the forms useful.”
Several comments on the proposal to remove the forms argued the step will decrease classification panel efficiency and “prejudice the petitioner,” but FDA disagreed, citing the economic and regulatory burden of the paperwork.
“We believe that a more efficient use of FDA and petitioner resources would be to focus on the detailed, rather than summarized, information that the petitioner, FDA, panelists, and the public provide in the proceeding concerning available valid scientific evidence about the device and the appropriate regulatory controls to provide reasonable assurance of the safety and effectiveness of the device,” FDA said in the final rule.
This change has made our processes more efficient, and the new rule will provide increased clarity and predictability for device manufacturers, which ultimately will result in patients having more timely access to safe and effective medical devices.
— Scott Gottlieb, M.D. (@SGottliebFDA) December 13, 2018
FDA estimates that the final rule will cost approximately $2 million over 10 years, due to the initial learning curve for the new system and additional device classification panel meetings. Cost savings deriving primarily from fewer paperwork filing requirements total approximately $50,000.
AdvaMed declined to comment on the final rule, saying it is still talking to member companies and reviewing the text.