As per 21 CFR 864. 4020(a), ASRs are defined as antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASRs are medical devices that are regulated by FDA. They are subject to general controls, including current Good Manufacturing Practices (cGMPs), 21 CFR Part 820, as well as the specific provisions of the ASR regulations (21 CFR 809.10(e), 809.30, 864.4020). The guidelines set by FDA for marketing the ASRs are known as “The ASR Rules”. The rule classifies most ASRs as Class I devices subject to general controls under section 513(a)(1)(A) of the Act, but exempt from premarket notification. To read more about the ASR Rule, follow the link .
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