SUPPLEMENTARY INFORMATION:

I. Background

This guidance serves to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence under the 510(k) program. Since the program's inception in 1976, FDA has periodically published documents, including guidance ( printed page 43754) documents, which describe FDA's approach and any changes therein to the 510(k) program. On June 30, 1986, FDA published a Blue Book Memorandum entitled “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum #K86-3” (the “#K86-3 Memorandum”). This document discussed general points regarding the process of determining substantial equivalence between a new device and a predicate device. On March 20, 1998, FDA published a guidance document entitled “The New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications” (“the New 510(k) Paradigm”). This guidance introduced two new 510(k) programs—the Special 510(k) and the Abbreviated 510(k)—as optional approaches available to device manufacturers and renames the original 510(k) program that had been in place since 1976 to the “Traditional 510(k).” Traditional, Special, and Abbreviated 510(k)s differ with respect to the scope and content of information that are included within the submission. It is noted that the #K86-3 Memorandum was issued as a final guidance prior to the February 27, 1997, implementation of FDA's Good Guidance Practices, 21 CFR 10.115. Neither the #K86-3 Memorandum nor the New 510(k) Paradigm has been updated since its initial publication. As further explained later in this section, this new guidance document will replace only the #K86-3 Memorandum.

On December 28, 2011, FDA announced the availability of “Draft Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (76 FR 81510) (the “Draft Guidance”). Interested persons were invited to comment by April 26, 2012. FDA received 26 sets of comments, totaling over 400 comments. While the sections on Special 510(k), technological characteristics, and predicate devices received the most comments, there were also requests for inclusion of examples to assist in defining the gray areas of how FDA interprets what would be considered substantially equivalent under the 510(k) program.

In response to these comments, the guidance was revised to provide a broader overview of the use of predicate devices and to explain more clearly the intent and value of defining a “primary predicate” device in the submission. Examples were added to several sections to clarify the boundaries and FDA's decision-making process for finding devices equivalent to a predicate that may have different indications for use, technological characteristics, or performance characteristics. There were requests for the addition of a “fillable form” to ensure consistency in the amount and type of detail expected in a 510(k) summary. In response, an appendix was added with a sample 510(k) summary, including clinical data, to demonstrate the level of detail that is expected in each regulatory mandated section upon finalization of the guidance to increase transparency.

Lastly, industry expressed concern relating to the inclusion of the Special 510(k) Program within this guidance, given the connection of this topic and determining when it is necessary to submit a new 510(k) for a device modification. In response, FDA elected to remove the sections addressing the alternatives to Traditional 510(k)s, specifically the Special and Abbreviated 510(k) programs that were included in the draft guidance. FDA intends to finalize these sections separately. Until FDA issues a new final guidance document on the Special and Abbreviated 510(k) Programs, the recommendations for Special and Abbreviated 510(k)s contained in the New 510(k) Paradigm remain in effect for these alternate submission types.

In response to other minor substantive and editorial comments, FDA revised the guidance document to clarify the processes and policies as appropriate.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm. Guidance documents are also available at http://www.regulations.gov or http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​default.htm. Persons unable to download an electronic copy of “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1766 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR 807 subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910-0130; the collections of information found in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.

V. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES ). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.