; and (2) the developer of the test— (A) maintains documentation demonstrating that such test meets and continues to meet the applicable criteria described in paragraph (1); (B) makes such documentation, such as a prescription order requesting the custom test for an individual patient, available to the Secretary upon request; and (C) informs the Secretary, on an annual basis, in a manner prescribed by the Secretary by guidance, that such test was introduced into interstate commerce. (i) Public health surveillance activities (1) In general The provisions of this subchapter shall not apply to a test intended by the developer to be used solely for public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. (2) Limitation Such activities— (A) are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, risk factors, patterns in diseases, or increases in injuries from using consumer products)