Authored and Edited by Clara N. Jiménez; Mark J. Feldstein, Ph.D.
The regulatory classification of a new human medical product is often one of the first and most important considerations for sponsors seeking to get their products into the market. Whether a product is classified as a drug, device, biological product, or combination product determines which FDA center has jurisdiction (or in the case of combination products, primary jurisdiction) for the premarket review and regulation of the product. A new process for obtaining a preliminary, non-binding designation of regulatory classification is now formally available at the various FDA medical product centers. One of these centers, the Office of Combination Products (OCP) has made Draft Guidelines for Industry available. The Guidelines shed light on how the new process will be implemented.
OCP has served as a resource for sponsors seeking to determine their products regulatory classifications, and provides feedback on product classifications. First, OCP provides formal, binding determinations of the product’s classification in response to a Request for Designation (RFD). Second, OCP can provide preliminary, non-binding assessments of product classification. The latter option is attractive to sponsors interested in determining the regulatory scheme that will apply to their products before completing a formal market submission. Recognizing the value of these preliminary assessments to sponsors, in 2016 FDA announced that it would standardize and formalize the preliminary assessment process. Under its new title, the Pre-RFD process aims to provide sponsors a written preliminary classification (or jurisdictional assessment) within 60 calendar days of submitting a pre-RFD request.
As the Guidance explains, the pre-RFD process, like the more formal RFD process, requires sponsors to submit a clear and concise written request that includes, at a minimum, a description of a product, its proposed use or indications and a description of a how the product achieves its intended therapeutic/diagnostic effect. Sponsors also have the option to provide supportive data and studies. Unlike RFD requests, pre-RFD requests currently do not have page limit restrictions. Nevertheless, the Guidance explicitly advises against submitting extraneous information that is likely to slow down the review process. While most pre-RFDs will be decided on the contents of the written request, sponsors may request a meeting with OCP if helpful to advance the review.
Pre-RFD may be sought at any point during medical product development. It may be especially beneficial when a medical product is at an early stage in its development, or when a sponsor is contemplating whether to develop a specific product, or what configuration of that product to pursue. Sponsors may withdraw a pre-RFD submission before the preliminary assessment is made. If a sponsor disagrees with the preliminary assessment it may file a new pre-RFD with additional information, or submit a formal RFD (which can be reconsidered 15 calendar days after the designation letter issues).
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