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# Comments on Product Jurisdiction Proposed Rule
- URL: https://www.fdaweb.com/comments-on-product-jurisdiction-proposed-rule/
- Published: 2018-07-18T12:00:00.000Z
- Updated: 2026-09-15T00:20:06.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5141909

Washington Legal Foundation (WLF) challenges the FDA position that its proposed product jurisdiction rule is intended to merely clarify existing regulations and update them to reflect agency practices and procedures. “WLF respectfully submits that the proposed rule accomplishes neither objective,” its [comment letter](https://www.regulations.gov/document?D=FDA-2004-N-0191-0012&ref=fdaweb.com) says. “Nor has FDA taken this opportunity to address significant flaws in the product-classification process, including the misalignment between that process and FDA’s statutory mandate.” The advocacy organization calls on the agency to revise the proposed rule along lines that it outlines.

Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/document?D=FDA-2004-N-0191-0015&ref=fdaweb.com) it is generally supportive of the proposed rule and believes a majority of the changes will enhance regulatory clarity and efficiency. However, it says, the trade group believes that the proposed change to eliminate the reconsideration process is not necessary to achieve the clarity and efficiency FDA seeks. PhRMA also offers three additional recommendations not addressed in the proposed rule: retaining the option for reconsideration and revising the appeals process, expanding the page limit for request for determination submissions, and clarifying the definition of combination product for cross-labeled purposes.

Bayer’s comment [letter](https://www.regulations.gov/document?D=FDA-2004-N-0191-0013&ref=fdaweb.com) asks FDA to clarify that sponsors have the right to go directly to an appeal, skipping the request for designation and reconsideration stages, if jurisdictional FDA comments received by a sponsor raise questions, for example, based on an evaluation of jurisdiction for cleared predicate applications. The company also suggests establishing timelines for jurisdictional appeals to add to regulatory certainty and increase timely access for patients to new innovative therapies.

LifeNet Health [says](https://www.regulations.gov/document?D=FDA-2004-N-0191-0016&ref=fdaweb.com) FDA should include in the rule express statements relating to the applicability of the regulation and its definitions to Human Cells, Tissues, and Cellular and Tissue-Based Products.

Finally, Pfizer [cautions](https://www.regulations.gov/document?D=FDA-2004-N-0191-0014&ref=fdaweb.com) that narrowing the scope of the process to sponsors only is too limiting. “We would recommend allowing both sponsors and partners the opportunity to use the request for designation process when the distributor or design partner may have confidential or proprietary information or questions for the agency that could not be shared with the sponsor,” it says. “In addition, FDA should allow non-sponsors, who may be the subject matter experts for a particular product or treatment, the opportunity to use the request for determination as they may provide a better technical explanation of the product or better communicate the issue at hand.”