(1) The following documents are incorporated into these rules by reference and can each be obtained by visiting the applicable web address shown below, where available, or by contacting the address shown in subsection (4): (a) The form entitled "Manufacturer's Answer, " DLA/LL-006 (rev. 2/06), effective 2-1-06. (b) The forms entitled "Consumer's Prehearing Information Sheet DLA/LL-007, (rev. 02/2023), effective 2-1-2023, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-14995 and Manufacturer's
(a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42 . FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously reviewed by a panel. If FDA refers an application to a panel, FDA will forward the PMA, or relevant portions thereof, to each member of the appropriate FDA panel for review. During the review process, FDA may