Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff.” The unique device identification system regulations require that the label and device package of a device must bear a unique device identifier (UDI), unless an exception or alternative applies. An exception is provided for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI. This guidance document describes FDA's interpretation of the definition of “convenience kit.” This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to IVD labeling requirements nor does it apply to combination products.
The announcement of the guidance is published in the Federal Register on April 26, 2019.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
- If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
- For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
Instructions: All submissions received must include the Docket No. FDA-2015-D-4048 for “Unique Device Identification: Convenience Kits: Guidance for Industry and Food and Drug Administration Staff; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 Start Printed Page 17836a.m. and 4 p.m., Monday through Friday.
- Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Unique Device Identification: Convenience Kits: Guidance for Industry and Food and Drug Administration Staff; Availability” to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.
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FOR FURTHER INFORMATION CONTACT:
For Center for Devices and Radiological Health-regulated devices: Christina Savisaar, Unique Device Identifier Regulatory Policy Support, 301-796-5995, email: GUDIDSupport@fda.hhs.gov. For Center for Biologics Evaluation and Research-regulated devices: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
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Start Supplemental Information
FDA is announcing the availability of a guidance entitled “Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff.” In the September 24, 2013, Federal Register (78 FR 58786), FDA published a final rule establishing the unique device identification system, which is designed to adequately identify medical devices during their distribution and use (the UDI Rule). Under 21 CFR 801.20, a device is required to bear a UDI on its label and packages unless an exception or alternative applies. Individual devices packaged within the immediate container of a convenience kit are excepted from the UDI labeling requirements of 21 CFR 801.20, provided that a UDI is on the label of the immediate container of the convenience kit (21 CFR 801.30(a)(11)). Convenience kits are themselves devices.
A convenience kit is “two or more different medical devices packaged together for the convenience of the user” (21 CFR 801.3). FDA interprets this to mean a device that contains two or more different medical devices packaged together and intended to remain packaged together and not to be replaced, substituted, or repackaged.
Although FDA previously expressed thinking that medical procedure kits containing only devices are convenience kits,
FDA believes that this policy requires clarification for consistency with the objective of the unique device identification system. For purposes of the UDI regulations, FDA does not consider every medical procedure kit, nor every collection of two or more medical devices, to be a “convenience kit.”
FDA recognizes that the interpretation of terms provided in this guidance may mean that fewer medical procedure kits are “convenience kits” for purposes of the UDI regulations, which may impact the assembly and packaging of medical procedure kits that are not “convenience kits.” Nevertheless, FDA believes that the interpretation of the term “convenience kit” in this guidance document is appropriate. As for all devices, a labeler may request an exception from or alternative to a UDI requirement under 21 CFR 801.55.
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 “Unique Device Identification—Convenience Kits; Guidance for Industry and Food and Drug Administration Staff”. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statute and regulations. This guidance is not subject to Executive Order 12866.
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. This guidance documents are also available at http://www.regulations.gov or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm]. Persons unable to download an electronic copy of “Unique Device Identification: Convenience Kits—Guidance for Industry and Food and Drug Administration Staff” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500010 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 Start Printed Page 17837Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the following FDA regulations have been approved by OMB as listed in the following table.
|21 CFR part||Topic||OMB control No.|
|801, subpart B, and 830||Unique Device Identification||0910-0720|
End Supplemental Information
Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08472 Filed 4-25-19; 8:45 am]
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