2011-15817. Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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 § 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 § 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 § 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

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.

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

§ 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.