| ASTM F2529-13 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 15-44 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 3.1.10.1 Clause 4.1 last sentence Clause 5.4.1 Clause 5.4.2 first sentence Clause 6.4 Clause 6.5 Annex X1.2.5.6 last sentence |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Tissue Engineering |
| FDA Tech | David Kaplan FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2519 david.kaplan@fda.hhs.gov |
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1.1 This guide covers general guidelines to evaluate the effectiveness of DBM-containing products intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents) to make the demineralized bone easier to manipulate. It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of unique bone-forming products in in vivo heterotopic models of osteoinductivity. The purpose of this guide is not to exclude other established methods.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3045 | Filler, Bone Void, Calcium Compound | Class 2 | MQV |
| §888.3045 | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | Class 2 | MBP |
| 2003 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device |