FDA Guidance for Industry
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
Issued: July 28, 2014
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].”
This guidance document describes FDA’s current review practices for premarket notification (510(k)) submissions by describing in greater detail the regulatory framework, policies, and practices underlying FDA’s review of traditional 510(k) submissions. This guidance document does not address the special and abbreviated 510(k) programs. FDA intends to finalize those sections separately.
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 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On December 28, 2011, FDA announced the availability of “Draft Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” (76 FR 81510)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. FDA issued the following guidance on August 8, 2016.
Deciding When to Submit a 510(k) for a Change to an Existing Device
- It is accessible at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf
Download FDA guidance
Last Updated: 2017-03-28
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