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The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications

Posted Date:2019/1/16

I. Introduction 

FDA developed this document to provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions. The intent of this guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence. This guidance is not intended to implement significant policy changes to the current 510(k) review process. Rather, the intent of this guidance is 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.

The draft of this guidance document contained sections addressing FDA’s Special and Abbreviated 510(k) programs. FDA intends to finalize those sections separately. Until FDA issues new final recommendations on the Special and Abbreviated 510(k) programs, the recommendations for Special and Abbreviated 510(k)s contained in

“The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,”

dated March 20, 1998,

(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0801 87.htm) remain in effect.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

II. Background 

A. The Medical Device Amendments and Device Classification

The Medical Device Amendments (MDA) (Pub. L. 94-295) to the Federal Food, Drug, and Cosmetic (FD&C) Act were enacted on May 28, 1976. The MDA directed FDA to issue regulations that classify all devices that were in commercial distribution at that time into one of three regulatory control categories: Class I, II, or III, depending upon the degree of regulation necessary to provide reasonable assurance of their safety and effectiveness. The class into which a device is placed determines the requirements that a medical device manufacturer must meet prior to distributing a device in interstate commerce.  According to section 513(a)(1) of the FD&C Act (21 U.S.C.

§ 360c(a)(1)), the three device classes are defined as follows:

· Class I: Devices are subject to a comprehensive set of regulatory authorities called general controls that are applicable to all classes of devices.

· Class II: Devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

· Class III: Devices for which general controls, by themselves, are insufficient and for which there is insufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device. Class III devices typically require premarket approval.

Premarket notification is the process by which a new device, i.e., a post-amendments device, is classified into one of these three device classes. A manufacturer who intends to market in the United States a Class I, II, or III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit to FDA a premarket notification submission (often referred to as a 510(k)), unless the device is exempt from the 510(k) requirements of the FD&C Act and does not exceed the limitations of exemptions for each of the device classification regulations (Section .9 of 21 CFR Parts 862 through 892, e.g., 21 CFR 862.9, 21 CFR 864.9, etc.). Under section 510(k) of the FD&C Act, a manufacturer must submit a 510(k) to FDA at least 90 days before introducing, or delivering for introduction, a device into interstate commerce for commercial distribution so the Agency can determine whether or not the device meets the criteria for market clearance (Sections 510(k) and (n) of the FD&C Act (21 U.S.C. §§ 360(k) & (n))). The Agency bases its decision on whether the device is substantially equivalent (SE) to a legally marketed (predicate) device (Section 513(i) of the FD&C Act (21 U.S.C. § 360c(i))). The device cannot be commercialized until FDA issues an order (510(k) clearance) stating that the device has been determined to be SE (Section 513(f)(1) of the FD&C Act (21 U.S.C. § 360c(f)(1))).

B. The 510(k) Classification Process

According to section 513(f) of the FD&C Act, a new (i.e., post-amendments) device is automatically in Class III and must undergo premarket approval or reclassification before it can be marketed, unless it is a type of device that was in commercial distribution prior to May 28, 1976, and is SE to another such device; or it is within a type of device introduced after May 28, 1976, that has been reclassified into Class I or II and is SE to another device within such classification. For information about how FDA’s classification product codes assist in accurate identification and tracking of current medical devices, please see FDA’s Guidance for Industry and Food and Drug Administration Staff,

“Medical Device Classification Product Codes” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm2853 17.htm).

When FDA determines under sections 510(k), 513(f)(1), and 513(i) of the FD&C Act that a new device is SE to a legally marketed (predicate) device, the new device is classified into the same class and subject to the same requirements as the predicate device. (See Section IV.C.) A determination that a new device is not substantially equivalent (NSE) to a predicate device results in the new device being classified into Class III. Thus, 510(k) review is both the mechanism by which a manufacturer seeks marketing authorization for a new device and by which FDA classifies devices into their appropriate regulatory category. Because devices are classified according to the level of regulatory control necessary to provide a reasonable assurance of safety and effectiveness, classification of a new device through the 510(k) process requires FDA to determine the issues of safety and effectiveness presented by the new device, and the regulatory controls necessary to address those issues.

C. Evolution of the 510(k) Program

Since its inception, the 510(k) program has undergone a number of statutory changes. Notably, the Safe Medical Devices Act of 1990 (Pub. L. 101-629) added section 513(i), which codified FDA review practice in applying the “substantial equivalence” review standard. In addition, FDA has modified its implementation of the program to adapt to changing circumstances and to accommodate the evolving medical device landscape. For example, the alternative options of a Special 510(k) or an Abbreviated 510(k) still exist today.  Additional information regarding these alternative options can be found in FDA’s guidance, “The New 510(k) Paradigm – Alternative Approaches to Demonstrating Substantial Equivalence in Premarket Notifications”

(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument s/ucm080189.pdf). The current 510(k) program reflects the current statutory framework and FDA’s implementation of that framework through regulation, guidance, and administrative practice. A history of the 510(k) program has been summarized in other documents that FDA has published.

This guidance document provides updated information to the existing guidance document entitled “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3” (K86-3 Guidance), issued on June 30, 1986. The K86-3 Guidance was written and issued as final guidance prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices (GGPs), and has not been updated since its initial publication date. This guidance replaces the K86-3 Guidance.

III. Scope 

This guidance provides recommendations to industry and FDA staff about the content of 510(k) submissions and the decision-making process for determining substantial equivalence of devices reviewed under the 510(k) program. The guidance has been organized to coincide with the critical decision points outlined in the 510(k) Decision-Making Flowchart (See Appendix A), which has been updated to track section 513(i) of the FD&C Act and relevant regulations more closely. 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 .

The overarching principles in this guidance are applicable to devices that are subject to 510(k) review by CDRH, including the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR), as well as devices that are subject to 510(k) review by the Center for Biologics Evaluation and Research (CBER). This guidance is not intended to supplant existing device-specific guidance, but may cover broader areas not addressed in device-specific guidance documents. If you have questions about how this guidance and a device-specific guidance apply to a particular issue, please contact FDA to discuss. In addition, this guidance does not address review issues unique to combination products. For information on combination products, please refer to the

Office of Combination Products webpage 

(http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScien ceandHealthCoordination/ucm2018184.htm).