What is the difference in GMP requirements for manufacturers of an ASR versus an RUO reagent?
Manufacturers establish and follow cGMPs, as established in the quality system regulation, to help ensure that their products are manufactured under controlled conditions that assure the devices meet consistent specifications across lots and over time. ASRs must be manufactured following cGMPs. 21 CFR 809.20. FDA does not expect RUO reagents to be manufactured in compliance with cGMPs because products labeled as RUO reagents cannot be used as clinical diagnostic products. 21 CFR 809.10(c)(2)(i).
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