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2	Ombudsman Person appointed to receive and investigate complaints about a government agency and to mediate or otherwise resolve disputes between that agency and the public Resolve disagreements at an early stage before they escalate Alternative Dispute Resolution (ADR) Conciliation, mediation, arbitration, and negotiation
3	Ombudsman (continued) Provide focus to existing appeal & dispute resolution mechanisms some informal and others more formal Get involved in any stage of CDRH’s decision making processes Accessible to industry, easing the way to be heard Look into complaints Listen to company issues and concerns
4	Ombudsman (continued) Strategize options available to challenge or appeal Shuttle diplomacy Informally mediate disputes Attend meetings of companies and CDRH Facilitate equitable resolution Promote and support fairness, accountability and equity
5	Ombudsman (continued) Catalyst to get CDRH staff to take a second look Are laws and regulations being applied consistently? Are policies and procedures in conformance with the law? Neutral and impartial Pledge of confidentiality
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7	Complaints and Disputes-2005 Source of contacts:
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10	Complaints and Disputes - 2005
11	Complaints and Disputes - 2005
12	Complaints and Disputes - 2005
13	Medical Devices Dispute Resolution Panel FDAMA – Section 404 Additional, more focused procedure for timely review of scientific disputes between FDA and sponsor, applicant or manufacturer Independent expertise of outside clinicians/scientists Congressional intent: fair, impartial and timely hearing
14	Dispute Resolution Panel FDA amended 21 CFR 10.75 Guidance on Resolving Scientific Disputes: A Guide to Use of Dispute Resolution Panel Issued 7/2/01
15	Dispute Resolution Panel Eight members: Five standing members 3 voting members with broad scientific/medical backgrounds 1 non-voting industry representative 1 non-voting consumer representative Three voting temporary members chosen to hear a particular dispute Makes recommendation to Center Director Who can concur, concur with exception(s), or not concur
16	Dispute Resolution Panel Has met only once to resolve a dispute September 2001 Much more common to appeal up the supervisory chain using 21 CFR 10.75
17	How to Contact the Ombudsman Les Weinstein Center for Devices and Radiological Health U.S. Food and Drug Administration 9200 Corporate Blvd. (HFZ-5) Rockville MD 20850 Phone: 301-827-7991 Fax: 301-827-2565 email: ombudsman@cdrh.fda.gov website: www.fda.gov/cdrh