Office of Device Evaluation (HFZ 400)
The purpose of this document is to provide the procedures for FDA staff to follow when requesting, receiving, handling, processing, and tracking formal consultative and collaborative reviews of combination products, devices, drugs and biologics between Centers.
Last fall the Commissioner's Office requested that CDRH, CBER and CDER develop an intercenter standard operating procedure to increase the efficiency of the intercenter review process. Representatives from each Center, headed by the Office of FDA's Ombudman, participated in developing this procedure. Additionally, several people from ODE also participated in the review of the draft SOP. The SOP on Intercenter Consultation and Collaboration was approved by all three Center Directors and went into effect as of July 31, 2002.
On July 31, 2002, FDA issued the SOP as an internal document to provide the policies and procedures for FDA staff to follow when requesting, receiving, handling, processing, and tracking formal consultative and collaborative reviews of combination products, devices, drugs and biologics. Attached is a signed PDF copy. The objectives are to improve intercenter communication on combination products, as well as the timeliness and consistency of intercenter consultative and collaborative reviews. The document describes key policies regarding the consultative/collaborative review process, as well as responsibilities and procedures to be followed by those requesting and conducting intercenter reviews. It is anticipated that the document will continue to be refined and updated as the program, headed by FDA's Office of Combination Products, evolves. In particular, this SOP does not address all possible details of the intercenter review process and collaborative reviews at this time, but the development process will be a continuing effort.
It’s important that we ensure that individuals involved in intercenter review work are aware of the document and understand its requirements. The SOP can also be accessed on the Web at: Intercenter Consultative/Collaborative Review Process; or, by clicking on the following link: Intercenter Consultative/Collaborative Review Process (PDF Version)
Effective Date: These procedures are effective as of July 31, 2002.
Daniel G. Schultz, M.D