FDA update December 28, 2011

Draft Guidance for Industry and Food and Drug Administration Staff CDRH Appeals Processes

This draft guidance document intends to

  • Describes the processes available to outside stakeholders to request additional review of decisions and actions by Center for Devices and Radiological Health (CDRH or the Center) employees.
  • When finalized, this guidance will supersede “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” dated February 1998 and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA,” dated July 2001.
  • Individuals outside of FDA who disagree with a decision or action taken by CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including: requests for supervisory review of an action; petitions; and hearings.
  • This draft document provides general information about each process, as well as guidance on how to submit related requests to CDRH and FDA.
  • 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 most effective means of resolving a dispute between the Center 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.
  • If this is unsatisfactory, it may be necessary or helpful for the relevant Branch Chief and members of Division management to be brought into the discussion.
  • The general expectation is that the stakeholder will follow an orderly progression of interaction with Center employees followed by outreach to relevant members of Management and then engagement with the CDRH Ombudsman, prior to filing a formal request for review or appeal.
  • Handling an appeal or reconsideration of a matter in dispute is a routine part of the Center’s business processes.
  • The Center is strongly committed to ensuring that an entity doing business with the Center is free from bias or retaliation at every stage of interaction, including the filing of an appeal of a Center action. If the submitter of an appeal or request for review believes that Center staff is engaging in bias or retaliation consequent to the submitter filing an appeal or otherwise formally challenging an agency decision, those concerns should immediately be brought to the attention of the Ombudsman.
  • Evidence of bias or retaliation in the form of email messages, meeting or teleconference minutes, or the like, is very helpful in establishing a basis for requesting relief.
  • Contact with the Ombudsman can be on a confidential basis if so requested, in which case the Center will protect the confidentiality of the information provided and the source of such information to the maximum extent possible under governing disclosure laws. Note that an appeal or review meeting is not intended to be the forum for airing allegations of bias or misconduct. An allegation of bias, misconduct or other wrongdoing should first be discussed with the Ombudsman and then submitted in writing directly to the Ombudsman, accompanied by documentation to support the allegation.
  • The Ombudsman will investigate the allegations and determine what, if any, further actions should be taken. A determination of whether an entity is being subjected to bias and/or retaliation is left to the discretion of the Ombudsman. If after an initial investigation the Ombudsman decides that there is insufficient basis to sustain an allegation of bias or retaliation, the rationale for this determination will be discussed with the complainant, affording an opportunity for further discussion or presentation of additional evidence. If the Ombudsman decides that there is legitimate basis to support an allegation of bias or retaliation, then the Ombudsman will pursue the matter through independent channels to the Commissioner’s Office. At that point a decision will be made whether to refer the matter for internal investigation.

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA  consideration to the Division of Dockets Management, Food and Drug Administration, 5630  Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FR Doc. 2011-33230

Or you can send your comments within 120 Days at info@mdiconsultants.com and REF: CDRH Appeals Processes

For more information on this guidance you can go to the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf