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# FDA Product Jurisdiction Reforms Needed: Attorney
- URL: https://www.fdaweb.com/fda-product-jurisdiction-reforms-needed-attorney/
- Published: 2016-03-02T12:00:00.000Z
- Updated: 2026-09-15T02:40:12.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5134942

> Attorney **Jeffrey Gibbs** (Hyman, Phelps & McNamara) says that how a therapeutic product is classified profoundly affects how it is regulated, and it is time to reform the FDA mechanism for classifying products. [Writing](http://www.fdalawblog.net/Gibbs%5FFDA%20and%20Product%20Jurisdiction.pdf?ref=fdaweb.com) in an online *FDLI Update*, Gibbs says that the two primary problems with the current system are **(1)** the substantive criteria used by FDA to classify products have evolved in ways that push more products into the pharmaceutical realm and **(2)** the process by which the agency makes its decisions has become less transparent and less predictable.  
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> The change in classification criteria in a way that favors drug classifications is seen in 2011 draft guidance documents and in litigation over the French company Prevor’s product used to treat skin exposed to chemicals, Gibbs writes.  
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> The article also cites a number of procedural issues that can affect both the outcome of the designation process and the manner in which applicants view the process. Covered are the page limit for a request for designation (RFD) and the Office of Combination Products’ (OCP) refusal to file requests for designation. “OCP started this program without public notification,” Gibbs writes. “OCP has provided no criteria for when it will refuse to file an RFD, leaving applicants in the dark.”  
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> “Although the RFD process can be efficient, it needs to be improved further,” Gibbs concludes. “Transparency and consistency need to be improved. A more formalized and predictable pre-submission process similar to CDRH’s pre-submission meeting program should be established. Beyond procedural reforms, FDA’s criteria for making jurisdictional decisions should be reexamined by FDA and Congress. Improving the product jurisdictional process is an area that warrants further review by Congress and FDA.”