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FDA Terminates the Medical Device Warning Letter Pilot Program

The March 1999 pilot program of providing the medical device industry with an incentive to promptly correct violations of deficiencies found during inspection has been terminated.

The FDA gave the following reasons for the termination of the program:

After evaluating its effectiveness, FDA has decided to discontinue the pilot. The pilot was intended to optimize resource utilization, enhance communication between the medical device industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. However, FDA has determined that the pilot has not provided incentives to promptly correct violations because firms that would have received warning letters if not for the pilot, did not have measurably better rates of compliance in follow up inspections than did firms that received warning letters. Also, FDA found that the pilot did not optimize resource utilization in that while the quantity of timely responses to inspectional observations increased, the quality of those responses generally decreased. Thus, FDA determined that the additional burdens placed on field staff by the pilot failed to optimize resources and reduced overall field inspectional effectiveness.

Additionally, on November 29, 2001, the Department of Health and Human Services directed FDA to submit all warning letters and untitled letters to FDA's Office of the Chief Counsel prior to their issuance for review of legal sufficiency and consistency with agency policy. FDA's new procedures for review of warning and untitled letters address some of the concerns that the medical device industry originally expressed to FDA during the grassroots meetings. The procedures have the added benefit of applicability to all FDA programs. They are expected to enhance consistency with agency policy among FDA district offices and centers, improve the legal sufficiency and quality of enforcement correspondence, and provide for timely feedback to regulated entities.

What does this mean for the medical device industry – more Warning Letters issued as a result of future inspection for sure.

For a copy of the final rule please visit the following address at the FDA website:

http://www.fda.gov/OHRMS/DOCKETS/98fr/021203c.htm

For more information on what this change in FDA policy means to the medical device industry contact mdi or watch for future Insight Reports.

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