| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
054
|
Date of Entry 07/06/2020
|
|
FR Recognition Number
|
15-59
|
| Standard | |
ASTM F2450-18
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products |
|
Scope/Abstract| 1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue-engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and providing reliable quality control data. |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| This standard is relevant for medical devices/combination products where tissue engineering is a component of the development and manufacture of the product |
|
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Biodegradable Polymer Implant Devices, Issued 1996.
Guidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, Issued September 1998.
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. |
