Solicitation #: FDA-19-223-SOL-00025
“As an Agency, the Food and Drug Administration has a rich history in its use and support of standards for regulatory purposes. Several Centers in the Agency rely on standards to facilitate areas across the total product life cycles of the areas under its regulatory jurisdictions. Since, 1997 and in accordance with FDAMA of 1997, the Food and Drug Administration (FDA) established a consensus standards program recognizing all relevant medical devices standards and acquiring an annual license agreement to have full electronic access to published medical device standards. This access includes the full versions of all relevant related standards (as listed below), download capability, and continual updating of the database to provide the most current versions of standards to FDA scientists and regulatory staff for the purpose of executing FDA’s regulatory responsibilities.
The objective of this contract is to acquire an online information retrieval system that provides instantaneous access to industry specifications and standards to serve the regulatory needs of the Agency where standards are utilized.”
Due date: 27 August 2019, 12:00 p.m. EDT