Draft Guidance for the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
The intent of this guidance is
- To provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions.
- To identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence.
- To enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying FDA’s 510(k) review.
- To update FDA’s policies with respect to the Special 510(k) program.
- This draft guidance is not intended to implement significant policy changes to the current 510(k) review process.
- In addition, this guidance addresses two alternative approaches to the Traditional 510(k) submission process: the Special 510(k) and the Abbreviated 510(k) programs.
This document provides guidance on the following issues:
- the appropriate use of multiple predicates
- the processes associated with determining whether a new device with new indications for use has a new intended use
- the process for determining whether different technological characteristics raise different questions of safety and effectiveness
- when performance data, with special emphasis on clinical performance data, may be necessary to support an SE determination and
- how to develop 510(k) Summaries to promote greater transparency in the 510(k) decision-making process.
PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FDA–2011–D–0652
Or you can send your comments within 120 Days at email@example.com and REF: Evaluating Substantial Equivalence.
For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf