As was discussed at the November F04.41 subcommittee meeting, given that eight years have passed since this standard was published, there have been advances in the field and guidance from the FDA that necessitate the revision of this standard. This standard needs to be updated to reflect recent changes to the definitions of current terms as well as the inclusion of new terms for manufacturing techniques that are increasingly being utilized in the field. For example, definitions for terms such as biomaterial and regenerative medicine should be revisited to reflect not only recent guidance from the FDA (i.e., guidance documents on the RMAT designation program, gene therapies, and long-term follow-up), but also recent publications on definitions for these terms (see Definitions of Biomaterials for the Twenty-First Century, 1st Edition). Finally, as previously mentioned, the standard does not include some terms that are now widespread in use in the TERM and TEMP fields. Specifically, terms related to 3D printing of tissues or cells, such as bioprinting and bioink, need to be included in this standard to maintain its relevance.
Date Initiated: 02-18-2020
Technical Contact: Catherine Zander
Ballot: F04.41 (23-01)
Status: Will Reballot Item
Ballot: F04.41 (23-02)
Status: Negative Votes Need Resolution