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This guidance represents the current thinking of the US Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if the approach meets the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA Office responsible for this guidance.



FDA frequently receives questions about medical product sponsors regarding the classification of their products.NUMX We believe that efficient, effective regulation is facilitated by providing guidance in the field of Requests for Designation (RFDs) and other classification activities. In addition, providing as much clarity and predictability as possible with respect to product classifications. Accordingly, we have prepared this guidance to make the Agency's current thinking about certain product classification issues.


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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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