The FDA recently issued a draft Guidance titled, “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications.” The draft Guidance states that its purposes are “to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence” and “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.” When finalized, the draft Guidance will replace two prior Guidance documents on the same subject, “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,” issued on June 30, 1986 and “The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” issued on March 20, 1998.

Although the draft Guidance “is not intended to implement significant policy changes to the current 510(k) review process,” it is nonetheless interesting. The draft Guidance includes a flowchart summarizing the 510(k) review process (reproduced at the end of this Alert), “which has been updated to track section 513(i) of the FD&C Act and relevant regulations more closely.” The draft Guidance also contains separate sections addressing the key points in the review process, including:

• the appropriate use of multiple predicate devices; 
• the processes related to determining whether a new device with new indications for use has a new intended use;  
• the process related to determining whether different technological characteristics raise different questions of safety and effectiveness; and, 
• when performance data, with special emphasis on clinical performance data, may be necessary to support a determination of substantial equivalence. 

The draft Guidance also includes sections discussing alternative 510(k) submissions known as the Special 510(k) and Abbreviated 510(k), and their contents, which continue as available options. The draft Guidance includes a second flowchart for determining when the use of these two options is appropriate. The complete text of the draft Guidance can be found here:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm282958.htm  

As always, it is important to remember that FDA Guidance documents (including drafts) are not binding on the FDA or industry, but rather represent FDA’s current thinking on a topic.