| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
044
|
Date of Entry 07/26/2016
|
|
FR Recognition Number
|
2-241
|
| Standard | |
ISO /TR 37137 First edition 2014-05-15
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants |
|
U.S. Identical AdoptionANSI AAMI ISO /TR 37137:2014
Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants |
|
Scope/Abstract| The objective of this Technical Report is to provide interim Part-by-Part guidance on potential adjustments to various test methods within the 10993 series to account for the intentional release of soluble components or degradation products from absorbable medical devices. The content is intended to add clarity and present potentially acceptable approaches for reducing the possibility of erroneous or misleading results due to the nature of the absorbable material. All suggestions should be considered as preliminary and subject to change, with final dispositions implemented through direct modification to the respective parts of ISO 10993. Thus, interim adoption of any of the described adjustments requires an accompanying written justification. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 6.3a) 1) i) I)
Clause 6.4a) 1) i)
Clause 6.5a) 4) i) I)
Clause 6.6c) 2) i) I)
Clause 6.6e) 1) ii)
Clause 6.8a) 1) i)
Clause 6.10a) 1) i) I)
Clause 6.11 f) 2) and f) 3) |
|
Transition Period
| FDA recognition of ISO/TR 37137 First edition 2014-05-15 [Rec# 2-241] will be superseded by recognition of ISO/TS 37137-1 First edition 2021-03 [Rec# 2-290]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-241] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 2-241] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
|
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood.
ISO 10993-6, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
ISO 10993-12, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued June 2016, Updated September 2020.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
