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

Citation84 FR 9530
Record Number2019-04883
Published date15 March 2019
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 84 Issue 51 (Friday, March 15, 2019)
[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
                [Notices]
                [Pages 9530-9531]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-04883]
                [[Page 9530]]
                -----------------------------------------------------------------------
                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2013-D-1574]
                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
                [[Page 9531]]
                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 [email protected] 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:
                ------------------------------------------------------------------------
                 21 CFR part; guidance; or FDA
                 form Topic OMB control No.
                ------------------------------------------------------------------------
                807, subpart E................ Premarket 0910-0120
                 notification.
                814, subparts A through E..... Premarket approval... 0910-0231
                814, subpart H................ Humanitarian Device 0910-0332
                 Exemption.
                812........................... Investigational 0910-0078
                 Device Exemption.
                ``De Novo Classification De Novo 0910-0844
                 Process (Evaluation of classification
                 Automatic Class III process.
                 Designation)''.
                ``Requests for Feedback on Q-submissions........ 0910-0756
                 Medical Device Submissions:
                 The Pre-Submission Program
                 and Meetings with Food and
                 Drug Administration Staff''.
                820........................... Current Good 0910-0073
                 Manufacturing
                 Practice (CGMP);
                 Quality System (QS)
                 Regulation.
                ------------------------------------------------------------------------
                 Dated: March 11, 2019.
                Lowell J. Schiller,
                Acting Associate Commissioner for Policy.
                [FR Doc. 2019-04883 Filed 3-14-19; 8:45 am]
                BILLING CODE 4164-01-P
                

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT