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Suggested Format for Developing and Responding to the FDA concerning Deficiencies in 510(k) and PMAs

November 2, the FDA issued a 7 page guidance document which was in two parts. The first part was for assisting the FDA Office of Device Evaluation (ODE) reviewer to develop direct, concise and complete deficiencies when requesting additional information from industry regarding an application that was under review. In the second part, the industry is provided with suggested format for responding to these requests for additional information.

Examples of well-constructed deficiencies as well as responses to these requests are provided.

Please be aware that the beginning of this document, the FDA has a boldly marked disclaimer, stating, "This document is intended to provide guidance. It represents the Agency’s current thinking on the above (subject). It does not create or confer any rights or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations or both."

With such a disclaimer it is curious why the agency spent the time and money to prepare such a document in the first place.

The guidance document goes on to state that it is the FDA’s contention that conscientious use of this document by both FDA staff and industry should help to save time, effort and resources by both parties. Though, as is stated in the disclaimer, there is no real need for the Agency to follow this guidance.

Unfortunately, there is no way to measure the real cost of preparing this document to the potential cost savings as a result of using or not using this guidance document.

But, if you are interested in seeing what the FDA’s current thinking on this subject is please email us a request for a copy of this document using our code Guidance Doc. Nov. 2,2000 , or go directly to the FDA’s website at www.FDA.gov/cdrh/modact/guidance/1195.html and you will be able to down load it yourself.

Our opinion of the document is that there is nothing new or interesting in the document to discuss. The document does not require any explanation. If you would like some assistance in understanding what you should do concerning an ODE deficiency please feel free to contact our office.

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