On Dec 27, 2011, the FDA released an important new draft guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications”. Once issued, this guidance will replace “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3” from 1986 and “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notification” from 1998.

New FDA Draft:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.pdf

The intent of this guidance is to explain and clarify each of the FDA critical decision points in the determination of the substantial equivalence (SE). It should be noted that there are no significant changes in the current 510(k) policy; rather the FDA is providing more detail information on the regulatory framework.

This guidance is addressing several key 510(k) issues including:

• The appropriate use of multiple predicates;
• Whether a new device with new indications for use has a new intended use (if indication raises different safety and effectiveness questions and precludes meaningful comparison);
• Whether different technological characteristics raise different questions on safety and effectiveness;
• Resolving discrepancies between the 510(k) flowchart and the FD&C Act;
• When performance data, including clinical performance data, may be necessary to support an SE determination;
• How to develop 510(k) summaries to promote greater transparency in the 510(k) decision making process; and
• Clarification on the Special and Abbreviated 510(k) submission options.

Some of the major points:

• The FDA adopts a flexible approach to determining SE to accommodate evolving technologies.
• The FDA will continue to allow the use of multiple predicates in certain circumstances to help demonstrate SE, however, the FDA recommends the use of primary predicate device to which an SE claim is being made.
• The use of “reference devices” was introduced. Reference devices would be used to support SE claims by industry in some situations where “split predicates” were previously used. Scientific rationale has to justify the use of a reference device.
• The FDA provides a detailed explanation of “intended use” and “indications for use” and the relationship of the two terms.
• The guidance provides several illustrative examples on how to use multiple predicates, reference devices, indication for use, technological characteristics and when clinical data is needed.
• The use of Abbreviated and Special 510(k)s continue to be acceptable as alternate approaches to a Traditional 510(k) to demonstrate substantial equivalence.
• A decision-making flowchart that serves as a companion to guidance text has been retained and further simplified.

As before, if you are unsure what information to include within a 510(k) submission, you may submit a pre-IDE submission and seek additional feedback from the FDA to ensure your submission contains appropriate data elements.

If you would like to share your opinion regarding this draft document, you can submit comments and suggestions directly to the FDA by April 26, 2012 via mail or submit at http://www.regulations.gov.