Human Lyophilized Dura Mater
Human lyophilized dura mater is a freeze-dried preparation of donor human dura mater tissue historically used as a surgical graft to repair defects in the meninges covering the brain or spinal cord. It is classified as FDA Class 2 under 21 CFR 882.5975 in the Neurology specialty; however, regulatory oversight has transitioned to CBER under 21 CFR Part 1271, where it is regulated as banked human tissue subject to donor eligibility, good tissue practice, registration, and listing requirements effective May 25, 2005. The product code is LEM. This device is flagged as an implant.
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Basic Information
- Product Code
- LEM
- Device Class
- FDA class 2
- Regulation Number
- 882.5975
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Cber review required - previously regulated as a device under 21 cfr 882.5975, now regulated in cber under section 361 as banked human tissue. See definition at §1271.3(d). Subject to donor eligibility, good tissue practice, registration and listing requirements under part 1271" the good tissue practice regulation http://www.Fda.Gov/cber/rules/gtp.Pdf became final effective may 25, 2005. It states that "on january 27, 2004, fda issued an interim final rule excepting human dura mater and human heart valve allografts from the definition of hct/p in § 1271.3(d) (69 fr 3823). Fda stated that, when the comprehensive framework is in place, fda intends that human dura mater and human heart valves will be subject to it, and that fda intends to revoke the interim rule at that time (69 fr 3823 and 3824). With the effective date of this final rule, fda is revoking the interim rule and revising the language in § 1271.3(d)."
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.