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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 8-633
Standard
ASTM  F2902-24
Standard Guide for Assessment of Absorbable Polymeric Implants
Scope/Abstract
1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components.

1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular, sutures, and dermal fillers), which may require additional and potentially essential application-specific evaluations.

1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semicrystalline absorbable polymer systems.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ASTM F2902-16 [Rec# 8-455] will be superseded by recognition of ASTM F2902-24 [Rec# 8-633]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-455] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-455] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4493 Suture, Absorbable, Synthetic, Polyglycolic Acid Class 2 GAM
Relevant FDA Guidance and/or Supportive Publications*
Dental Bone Grafting Material Devices - Class II Special Controls Guidance for Industry and FDA Staff, issued April 2005.

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions, issued August 2025.

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 Contact
 Jinrong (Jinny) Liu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-3160
  jinrong.liu@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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