How does a manufacturer know whether its device is an ASR?
We recommend that ASR manufacturers consult this document for guidance on whether their product is or is not within the scope of the ASR rule. Manufacturers should contact FDA if they are unsure about the classification of their device to discuss any applicable regulatory requirements. Manufacturers who wish to obtain FDA advice on this matter in advance of marketing may consult with OIVD, or, with CBER for questions about HIV ASRs or ASRs for blood or cellular and tissue products.
