CDRH Ombudsman

Role

The CDRH Ombudsman, Les Weinstein, investigates complaints from outside FDA, and facilitates the resolution of disputes between CDRH and the industry it regulates. The CDRH Ombudsman is a good starting point if you have a complaint, question, or dispute of a scientific, regulatory, or procedural nature. He can answer questions, follow up on a complaint, discuss appeal and dispute resolution options, or mediate a dispute. While providing this assistance, he maintains his impartiality and neutrality. The Ombudsman advises the Center Director, Dr. Dan Schultz, to whom he reports, on ways to assure that our procedures, policies and decisions are of the highest quality and are fair and equitable.

Relation to FDA Office of the Ombudsman

The function of the CDRH Ombudsman parallels that of the FDA Office of the Ombudsman, located in the Office of the FDA Commissioner, but provides an avenue for resolving complaints involving CDRH programs at a level closer to the source. Because the FDA Office of the Ombudsman has agency-wide jurisdiction, it is appropriate to contact that Office when an issue involves more than one FDA center, or at any time when involvement by someone outside CDRH would be useful. The FDA Office of the Ombudsman also determines the appropriate classification and regulatory path for combination products and for drug, device, and biological products when the jurisdiction over a product is unclear or in dispute.