What does the ASR rule require?
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. The general controls require ASR manufacturers to register and list their devices, 21 CFR 807.20(a), submit medical device reports (21 CFR Part 803), follow labeling requirements, 21 CFR 809.10(e), and follow cGMPs, 21 CFR 809.20(b). The rule also restricts the sale, use, distribution, labeling, advertising and promotion of ASRs. 21 CFR 809.30. One of these restrictions allows only physicians and other persons authorized by applicable State law to order LDTs that are developed using ASRs. 21 CFR 809.30(f). Another restriction requires the laboratory that develops an LDT using an ASR to add a statement disclosing that the laboratory developed the test and it has not been cleared or approved by FDA when reporting the test result to the practitioner. 21 CFR 809.30(e). The restrictions also prohibit advertising and promotional materials
