Issue Date: May 19, 1997
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket,
Status: Final
Convenience Kits Interim Regulatory Guidance
This document is intended to provide guidance regarding a new premarket notification regulatory strategy for convenience kits. 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, regulations, or both. Public input on this document was not obtained prior to implementation because it is believed that this guidance presents a less burdensome policy that is consistent with public health. While this guidance document represents a final document, comments and suggestions may besubmitted at any time for Agency consideration by contacting the Premarket Notification (510(k)) Section at 301-796-5640. For questions regarding the use or interpretation of thisguidance, contact the Premarket Notification (510(k)) Section at 301-796-5640. Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Convenience Kits Interim Regulatory Guidance As part of the Center for Devices and Radiological Health’s organizational transformation initiative, the 510(k) Process Reengineering Team has been carefully examining the Premarket Notification (510(k)) Program to insure that it is operating at peak efficiency and that the optimum public health benefit is achieved given the allotted resources. During the preliminary examination of the requirements and execution of the 510(k) Program, the Team identified a change to the Program that may reduce the regulatory burden for assemblers of convenience kits. Outlined below is a new regulatory approach to be applied to convenience kits which could result in a decrease in the number of 510(k) submissions for these devices and, in so doing, will save ODE review resources. It is estimated that the Office of Device Evaluation (ODE) receives approximately 300 510(k) submissions per year that could be impacted by this regulatory approach. Background Under the current regulations, first time marketers of devices must submit a premarket notification and obtain clearance for a device before it can be lawfully introduced into interstate commerce. Assemblers/manufacturers of convenience kits who intend to market these devices for the first time are subject to these requirements. Many of the kits that have been the subject of 510(k) review are comprised of legally marketed devices that are simply being assembled in kit form strictly for the “convenience” of the purchaser or user, thus the term “convenience kit.” During the review of convenience kit 510(k)s, ODE has traditionally focused its efforts on the intended use(s) of the particular type of kit, the device components that are included in the kit, and the impact that any further processing may have on the kit and/or its components. The labeling for these kits tends to be rather basic, identifying the assembler or manufacturer of the particular kit and the intended use(s). Additional processing typically involves affixing the label to the outside packaging of the kit and terminal sterilization of the kit and its components. New Regulatory Approach Based on this experience, FDA believes that under certain circumstances premarket clearance for convenience kits may not be necessary to ensure protection of the public health. Accordingly, FDA intends to propose rulemaking to exempt certain, specifically identified convenience kits from the requirement of premarket notification. Until such a rule is in effect, FDA intends to exercise enforcement discretion regarding the requirement for premarket clearance for convenience kits that conform with the specific limitations regarding intended use, components, and processing described below. • Intended Use Using the 510(k) database, ODE has developed the attached list of generic types of kits that the Agency believes represents established intended use(s) for convenience kits and that does not modify the intended use(s) of the individual kit components. FDA recognizes that additional types of kits may currently exist that should be subject to this guidance. Likewise, FDA anticipates that other types of kits may become eligible for consideration in time. Thus, the list may be periodically updated based on the Agency’s experience with this new regulatory approach as well as on comments received from interested parties. • Components Convenience kits subject to this guidance should only include components that are either: (1) legally marketed preamendments devices, (2) exempt from premarket notification, or (3) have been found to be substantially equivalent through the premarket notification process. The components should be purchased in finished form, i.e., they should be packaged, labeled, etc., consistent with their legal marketing authorization. • Processing This guidance only applies in instances where the kit assembler/manufacturer concludes that further processing, if any, of the kit does not significantly affect the safety or effectiveness of any of the kit’s components. In making this determination, FDA recommends that kit manufacturers follow the procedures described in FDA’s guidance document entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It is the responsibility of each kit assembler/manufacturer to carefully consider the impact that any processing may have on the kit’s components. In the past, sterilization has been a focus of the 510(k) review for convenience kits; therefore, kit assemblers should carefully consider the impact of the sterilization process on individual kit components. If the kit’s components may be sensitive to further processing, e.g., surgical sutures, the assemblers/manufacturers should take measures necessary to ensure that the components are not adversely affected by the reprocessing procedures. In summary, FDA intends to exercise its enforcement discretion, i.e. not require 510(k) clearance, for convenience kits of a type matching one of those included on the attached list, consisting of components that have been cleared through the 510(k) process, and where the assembler/manufacturer is able to reasonably conclude that any further processing of the kit and its components does not significantly affect the safety or effectiveness of any of its components. Documentation to support each of these determinations should be maintained in the assembler’s/manufacturer’s files in accordance with the Quality System regulation (21 CFR 820) and should be available for FDA review if needed. It should be noted that while FDA intends to exercise enforcement discretion with respect to premarket notification requirements, assemblers/manufacturers of convenience kits are still required to comply with other general controls including registration, listing, prohibition against misbranding, and good manufacturing practices. In the future, FDA intends to propose rulemaking to formally exempt these types of kits from the requirement of premarket notification. Limitations FDA does not intend to propose regulatory changes relating to drug requirements for convenience kits. For convenience kits that contain components subject to regulation as drugs, the assembler/manufacturer should contact Kevin Budich, Center for Drug Evaluation and Research, Division of New Drugs and Labeling Compliance, (301) 827-8979 regarding premarket requirements for the drug components in the kit. This guidance is not intended to apply to kit 510(k)s that are under the jurisdiction of the Center for Biologics Evaluation and Research (CBER). For information regarding kits reviewed by CBER, the assembler/manufacturer should contact Sheryl A. Kochman, Office of Blood Research and Review, Division of Blood Applications, Biologics Devices Branch at (301) 827-3524. Effective Date Types of Convenience Kits The attached list of convenience kits was developed based on FDA’s database and is organized by medical speciality. For purposes of this document, the terms “kit,” “set,” and “tray” are considered synonymous. This list may be periodically updated based on the Agency’s experience with this guidance as well as on comments received from interested parties.
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