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Dispute Resolution Guidance |
Persons who wish to have a CDRH decision or action reviewed and reconsidered have a broad array of processes from which to choose, ranging from quick, informal approaches to more formal proceedings. CDRH has developed three guidance documents that focus on dispute resolution processes and procedures:
CDRH Guidance Documents on Dispute Resolution
Among the dispute resolution processes described are --
See the guidance document for a full list and further details on these and other processes.
FDA has established this new Dispute Resolution Panel within the Medical Devices Advisory Committee. The CDRH Ombudsman may grant request for review of a scientific dispute by this Panel.
In addition to serving as a useful forum in which scientific disputes in general can be aired, the Dispute Resolution Panel implements four requirements of the Federal Food, Drug, and Cosmetic Act:
Section 514(b)(5) requires the establishment of an advisory committee to take referrals of any matter concerning the establishment, amendment, or revocation of a performance standard which requires the exercise of scientific judgment.
Section 515(g)(2)(B) requires the establishment of an advisory committee to take referrals of petitions for review of -
the approval, denial, or withdrawal of approval of a premarket approval application, or
the revocation of an approved product development protocol (PDP), a declaration that an approved PDP has not been completed, or a revocation of an approved Notice of Completion that permitted marketing of a device developed under a PDP.
Section 522(b) requires a process to resolve any disputes concerning the need for FDA to order a manufacturer to conduct postmarket surveillance for more than 36 months.
Section 562 requires FDA to provide a procedure for review of all scientific disputes regarding the regulation of medical devices, including review by an appropriate scientific advisory panel, but only to the extent that other provisions of the act or FDA regulations do not already provide a right of review. FDA believes its current procedures already provide methods to obtain review of most, if not all, scientific disputes. The establishment of the Dispute Resolution Panel provides an additional, more focused, procedure for the timely review of scientific disputes.
This Guidance includes suggested ways to resolve certain "least burdensome" issues including contacting the CDRH Ombudsman to facilitate the resolution of these issues.
Updated February 5, 2007
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