Regulatory Open Forum

Hi Martina,

Your understanding of the first column in Table A.1 is correct.

The expectations of regulators for chemical characterization of legacy devices has not yet been worked out, to my knowledge.  Part 18 makes clear that testing is not always needed, and chemical characterization may be based on knowledge of the materials (i.e., a compositionally based approach).  This would require reasonably detailed information from suppliers about formulations, as well as analysis of the manufacturing processes (e.g., all contacting materials and possible residues).  If the material is manufactured to an existing standard, that factor can be useful as well. 

As you note, the scientific literature on the material(s) can also be helpful in building a chemical characterization.  Consider also bringing in whatever information you may have on history of safe use (please refer back to my response on 20May2021 to your prior question about this point).

A final consideration is that in revising 10993-1 the TC considered it important to address legacy devices, so Clause 4.11 has this to say:

This document shall not be used to mandate re-testing of historical products assessed previously using the appropriate edition of this document at the time of the assessment. Nevertheless, compliance to this new edition shall be shown, by providing a justification for omission of further testing. Where recommendations for endpoint assessment per Annex A are different from prior published versions of this document, a history of safe clinical use can be used to document why additional testing on a commercially-marketed medical device is not needed. However, if any of the changes described in Clause 4.9 occur, an evaluation of the biologic risks related to the change shall be performed using the current version of this standard.