New FDA guidelines for CDRH complainants

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The FDA has issued draft guidance describing the processes available to anyone wishing to dispute decisions and actions by the Center for Devices and Radiological Health (CDRH).

Released Dec. 27, 2011, the new guidance will, when finalized, supplant guidance dating to 1998 and 2001, according to the draft’s introduction. The draft document provided general information about each process available to stakeholders seeking redress, along with guidelines on how to submit related requests to CDRH and the FDA.

“Keep in mind as you read over this material that for any situation, multiple processes for resolution may be available,” the FDA stated. “It is up to the party seeking review of an adverse decision or resolution of a difference of opinion to determine the appropriate process for a given circumstance or issue.”

The draft introduction noted that the most effective means of resolving a dispute between CDRH and an external stakeholder is through “discussion and agreement. The Center Ombudsman is available to assist in clarifying issues, mediating meetings and teleconferences, and conducting discussions with the parties in an effort to resolve disagreements short of a formal review or appeal. Before contacting the ombudsman, a stakeholder should have made reasonable efforts to discuss the decision or action in dispute with the individual charged with managing the matter at issue,” such as the lead reviewer in the Office of Compliance for a warning letter or the epidemiologist in the Office of Surveillance and Biometrics for a post-approval study issue.

To read the draft guidance and consider submitting comments, click here.