Last synced on 27 January 2023 at 11:04 pm

Human Lyophilized Dura Mater

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5975
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code LEM is linked to regulation 21CFR882.5975, which does not seem to exist yet. It may be pending at the moment.

Human Lyophilized Dura Mater

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5975
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code LEM is linked to regulation 21CFR882.5975, which does not seem to exist yet. It may be pending at the moment.