FDA's Guidance to Selecting a Regulatory ConsultantFDA's Guidance to Selecting a Regulatory Consultant

Originally Published MDDI March 2005Guide to OutsourcingFDA’s Guidance to Selecting a Regulatory ConsultantRon Johnson

March 1, 2005

3 Min Read
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Originally Published MDDI March 2005

Guide to Outsourcing

FDA's Guidance to Selecting a Regulatory Consultant

Ron Johnson

The following is based on a guidance originally published July 6, 1993, in the CDRH Office of Compliance Industry Letter No. 2.

As the number of consultants has increased in the past few years, so too has our concern about their qualifications and the quality of their work. While most consultants accurately and honestly promote their capabilities, we believe the device industry should exercise diligence in the selection of a consultant. It is very disappointing to see a company which is experiencing serious problems go to the expense of hiring a consultant who fails to constructively contribute to the restoration of the company's regulatory health.

Of course, FDA cannot recommend or endorse a particular consultant, but we can offer some criteria that should be considered when selecting one. You should first determine what type of consultant you need. There are basically three types of consultants: regulatory, quality, and technical. A regulatory consultant is one that will specialize in 510(k) and PMA issues, quality systems and GMPs, and/or device labeling. A quality consultant is adept at quality system/GMP auditing and writing and revising procedures. A technical consultant knows how to find problems and fix them. In some cases, a company may need the services of one or more of these consultants. The ideal consultant would be highly qualified in all three of these areas. Since we in compliance deal most with quality system and GMP issues, we have identified some factors that we recommend you consider when selecting a quality consultant. However, the following factors may apply to other types of consultants as well:

• How long has the consultant worked with the device (not drug) quality system and GMP regulation?
• Is his or her knowledge current?
• Does he or she know CDRH's current policies and interpretations for device quality systems and GMPs?
• Does the consultant sponsor or participate in training courses?
• Is he or she frequently asked to give presentations at FDA or
industry-sponsored seminars? What have been the reactions
to these presentations?
• One of the primary attributes of a good consultant is to be a good communicator. He or she must be able to communicate problems and provide solutions in a clear, concise manner and in such a way that the company knows how to perform corrections the right way, the first time.
• Has he or she testified and/or been deposed as an expert witness, either for FDA or for industry?
• Can the consultant provide a listing of its clients over the last several years? Check those references.
• What types of certification does a consultant have (e.g., is the certification recognized by professional societies, etc.)?

We believe that a little homework in identifying and selecting a consultant will have long-term payoffs for any company.

Ron Johnson is executive vice president of Quintiles Consulting (Research Triangle Park, NC). At the time he wrote this guidance, he was director of CDRH's Office of Compliance. He worked at FDA for 30 years.

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