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U.S. Department of Health and Human Services

Product Classification

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Device human lyophilized dura mater
Regulation Description Human dura mater.
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).".
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeLEM
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type 510(k)
Regulation Number 882.5975
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA Staff
Third Party Review Not Third Party Eligible
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