[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Rules and Regulations]
[Page 36993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-1997-N-0040] (formerly Docket No. 1997N-0484P)


Medical Devices; Neurological Devices; Clarification of 
Classification for Human Dura Mater; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the device 
regulations to clarify the applicability of the device classification 
for human dura mater. This action is being taken to improve the 
accuracy of the regulations.

DATES: This final rule is effective June 24, 2011.

FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA is clarifying the regulatory authority 
for human dura mater in the Agency's codified regulations for part 882 
(21 CFR part 882). In the Federal Register of November 24, 2004 (69 FR 
68612), FDA published a final rule regarding current good tissue 
practice for establishments that manufacture human cell, tissue, and 
cellular and tissue-based products (HCT/Ps). That rule became effective 
on May 25, 2005. Prior to the effective date of the final rule, human 
dura mater was regulated as a medical device under Sec.  882.5975. As 
stated in the final rule, human dura mater is now defined under 21 CFR 
1271.3(d) as a HCT/P. As such, it is regulated under section 361 of the 
Public Health Service Act (42 U.S.C. 264) and the requirements of 21 
CFR part 1271, including requirements related to registration and 
listing, donor eligibility determinations, and current good tissue 
practice. Accordingly, the device classification contained in Sec.  
882.5975 is only applicable for human dura mater recovered prior to the 
effective date of the final rule, May 25, 2005. The final rule omitted 
a corresponding annotation to Sec.  882.5975 to clarify that the device 
classification is only applicable for human dura mater recovered prior 
to the effective date of the final rule. This document clarifies the 
regulatory authority for human dura mater. Publication of this document 
constitutes final action under the Administrative Procedure Act (5 
U.S.C. 553). FDA has determined that notice and public comment are 
unnecessary because this amendment is nonsubstantive.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Section 882.5975 is amended by adding paragraph (c) to read as 
follows:


Sec.  882.5975  Human dura mater.

* * * * *
    (c) Scope. The classification set forth in this section is only 
applicable to human dura mater recovered prior to May 25, 2005.

    Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15817 Filed 6-23-11; 8:45 am]
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