Can an ASR manufacturer supply quality control materials/reagents that can be used with an ASR?
Yes, but these materials should be promoted independently of specific ASRs. Marketing such materials for use with an ASR would indicate that the ASR manufacturer is actually marketing a product which could trigger premarket review requirements. Quality control materials should be promoted and sold using existing FDA classifications for quality control material (e.g., 21 CFR 862.1660, 862.3280, 864.8625).
