<searchTitle>Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period; Federal Register Vol. 89, Issue </searchTitle>
<granuleClass>NOTICE</granuleClass>
<accessId>2024-24447</accessId>
<agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
<agency order="2">Food and Drug Administration</agency>
<commentDate>2024-12-19</commentDate>
<departmentDoc>Docket No. FDA-2024-D-4165</departmentDoc>
<billingCode>4164-01-P</billingCode>
<frDocNumber>2024-24447</frDocNumber>
<action>Notice of availability; extension of comment period.</action>
<summary>The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of September 20, 2024. In the notice, FDA requested comments on the draft guidance for industry and FDA staff entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.</summary>
<dates>FDA is extending the comment period on the notice published September 20, 2024 (89 FR 77162). Submit either electronic or written comments on the draft guidance by December 19, 2024, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.</dates>
<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.</contact>
<tocSubject1>Guidance</tocSubject1>
<tocDoc>Chemical Analysis for Biocompatibility Assessment of Medical Devices, </tocDoc>
<emailRef>CDRH-Guidance@fda.hhs.gov</emailRef>
<emailRef>erica.takai@fda.hhs.gov</emailRef>
<emailRef>OSEL_CDRH@fda.hhs.gov</emailRef>
<urlRef>https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</urlRef>
<urlRef>https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</urlRef>
<urlRef>https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</urlRef>
<urlRef>https://www.regulations.gov</urlRef>
<urlRef>www.fda.gov/regulatory-information/search-fda-guidance-documents</urlRef>