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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-D-4165]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice of availability.
 SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Chemical Analysis for Biocompatibility Assessment of Medical Devices.” FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The biocompatibility of medical devices is evaluated based on the duration of exposure and nature of contact with the body. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. This draft guidance is not final nor is it for implementation at this time.
 DATES: Submit either electronic or written comments on the draft guidance by November 19, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
 ADDRESSES: You may submit comments on any guidance 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.*( print page 77163)
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-2024-D-4165 for “Chemical Analysis for Biocompatibility Assessment of Medical 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, 240-402-7500. 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.govinfo.gov/​content/​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, 240-402-7500. 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 draft guidance document entitled “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to the Office of Policy, 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: The Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Silver Spring, MD 20993-0002, 301-796-2530, or by email 
                        *OSEL_CDRH@fda.hhs.gov,*
                         Erica Takai at 301-796-6353, or by email at 
                        *erica.takai@fda.hhs.gov,*
                         or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.


SUPPLEMENTARY INFORMATION: I. Background FDA is issuing this draft guidance to describe recommended methodological approaches for chemical analysis for biocompatibility assessment of medical devices. The biocompatibility of medical devices is evaluated based on the duration of exposure and nature of contact with the body. Chemical characterization is one approach that manufacturers can consider when developing a strategy for the overall biocompatibility assessment of a device. Chemical characterization can be an alternative to biological testing for evaluating some biocompatibility endpoints. Use of chemical characterization can reduce the time needed to complete biocompatibility testing, reduce animal testing, generate data on the chemical constituents of a device, and be used to evaluate multiple biocompatibility endpoints at once. FDA and other stakeholders have observed variability in the approaches of individual laboratories performing analytical chemistry testing that has resulted in inconsistent analytical chemistry reports. The recommendations in this guidance are intended to improve the consistency and reliability of analytical chemistry studies. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Chemical Analysis for Biocompatibility Assessment of Medical 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. II. Electronic Access Persons interested in obtaining a copy of the draft 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/​medical-devices/​device-advice-comprehensive-regulatory-assistance/​guidance-documents-medical-devices-and-radiation-emitting-products.*
                     This guidance document is also available at 
                    *https://www.regulations.gov,**https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents*, or 
                    *https://www.fda.gov/​vaccines-blood-biologics/​guidance-compliance-regulatory-information-biologics.*
                     Persons unable to download an electronic copy of “Chemical Analysis for Biocompatibility Assessment of Medical 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 GUI00020037 and complete title to identify the guidance you are requesting. III. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of 
                    ( print page 77164)
                    information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations, guidance, and forms 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 notification
0910-0120814, subparts A through E
Premarket approval
0910-0231814, subpart H
Humanitarian Device Exemption
0910-0332812
Investigational Device Exemption
0910-0078860, subpart D
De Novo classification process
0910-0844“Requests for Feedback on Medical Device Submissions: The Q-Submission Program and Meetings with Food and Drug Administration Staff”
Q-Submissions and Early Payor Feedback Request Programs for Medical Devices
0910-0756
 Dated: September 17, 2024. Lauren K. Roth, Associate Commissioner for Policy.


[FR Doc. 2024-21575 Filed 9-19-24; 8:45 am] BILLING CODE 4164-01-P