Recognized standard

F2027-16

FDA recognition 15-49 · ASTM · Tissue Engineering

Key facts

Recognition number 15-49
Designation F2027-16
Title Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Standards developer ASTM International
Specialty area Tissue Engineering
Date of entry Aug 21, 2017
Scope (excerpt) 1.1 This document provides guidance on writing a materials specification for raw or starting materials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to materials that are already in a scaffold form or are…

At a glance

  • None Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards