Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices); Guidance for Industry and Food and Drug Administration Staff; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” FDA is issuing this guidance to update the policy regarding the use of animal-derived material in medical device manufacturing. These animal-derived materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured. The guidance describes the information manufacturers should document at the manufacturing facility and include in any premarket submissions.

DATES:

The announcement of the guidance is published in the Federal Register on March 15, 2019.

ADDRESSES:

You may submit either electronic or written comments on Agency guidances at any time as follows:

Electronic Submissions

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”).

Written/Paper Submissions

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-2013-D-1574 for “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” 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 a.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 “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)” to the Office of the Center Director, 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. Send one self-addressed adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT:

Anjana Jain, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G450, Silver Spring, MD 20993-0002, 301-796-6363; or Scott McNamee, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-5523.

SUPPLEMENTARY INFORMATION:

I. Background

This guidance entitled “Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices)” updates the November 6, 1998, guidance of the same name regarding the use of animal-derived material in medical device manufacturing. The 1998 guidance addressed ways to reduce the potential for exposure to bovine spongiform encephalopathy. The revised guidance continues to focus on the control of transmissible disease and contains recommendations for documenting the source of animal tissue, conducting viral inactivation validation studies, as well as recommendations about the role of careful animal husbandry in ensuring safe tissue sources. The revised guidance also includes recommendations related to viral pathogens and all transmissible spongiform encephalopathies.

The information in this guidance is applicable to all medical devices that contain or are exposed to animal-derived materials (e.g., bovine, ovine, porcine, avian materials) with the exception of in vitro diagnostic devices and materials generally recognized to be safe based on their method of manufacture. This guidance provides: (1) Information that FDA believes is important to document the safe and consistent manufacture of medical devices containing animal tissue; (2) information that should be included in a premarket submission for products within the scope of this guidance; (3) recommendations regarding how specific aspects of the Quality System (QS) Regulation should be applied to control and document the safe and consistent manufacture of medical devices containing animal tissue; and (4) additional information on specific approaches for determining the ability of manufacturing methods to eliminate viral contamination in the final product. Consideration of these items should aid in reducing the risk of infectious disease transmission by medical devices. FDA considered comments received on the draft guidance that appeared in the Federal Register of January 23, 2014 (79 FR 3826). FDA revised the guidance as appropriate in response to the comments.

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 current thinking of FDA on medical devices containing materials derived from animal sources (except for in vitro diagnostic devices). It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices)” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 2206 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information. 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table: