LEM

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Human Lyophilized Dura Mater

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5975

Medical specialty

Neurology

Flags

Implant

FDA 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

Adverse events (MAUDE)

1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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