21 C.F.R. § 516.131

Current through May 31, 2024
Section 516.131 - Refuse to file a request for determination of eligibility for indexing
(a) If a request for determination of eligibility for indexing contains all of the information required by § 516.129 , FDA shall file it, and the filing date shall be the date FDA receives the request.
(b) If a request for a determination of eligibility lacks any of the information required by § 516.129 , FDA will not file it, but will inform the requestor in writing within 30 days of receiving the request as to what information is lacking.

21 C.F.R. §516.131