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# FDA Denies Nitric Oxide Petition
- URL: https://www.fdaweb.com/fda-denies-nitric-oxide-petition/
- Published: 2020-09-02T12:00:00.000Z
- Updated: 2026-09-14T16:27:24.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147569

FDA has denied two of three issues raised in a 1/14/2013 petition filed by the law firm of Kleinfeld, Kaplan and Becker. The petition asked that the agency **(1)** reconsider and rescind the 5/16/2012 510(k) clearance for the GeNOsyl MV-1000; **(2)** require NDA approval before marketing any GeNO LLC nitric oxide delivery system that manufactures any portion of the finished pharmaceutical at the bedside by chemically converting nitrogen dioxide into nitric oxide for patient administration; and **(3)** refuse to approve any NDA for a GeNO nitric oxide delivery system that chemically converts nitrogen dioxide into the finished pharmaceutical nitric oxide at the patient’s bedside unless it incorporates appropriate current good manufacturing practices that assure that the nitric oxide meets NDA specifications. The FDA [response](https://www.regulations.gov/contentStreamer?documentId=FDA-2013-P-0070-0013&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) denied the first two requests and said the third request and issues raised in a 9/11/2014 petition supplement had already been answered by CDER.

In its response, the agency said its decision not to rescind the 510(k) clearance of the MV-1000 was consistent with a 9/26/2014 DC Court of Appeals decision that FDA could not rely on inherent reconsideration authority to rescind its initial substantial equivalence determination of a surgical mesh device.

FDA also said that a decision regarding the appropriate premarket pathway for the products as a group is not warranted at this time. “FDA will determine the appropriate premarket regulatory pathway for the GeNO products you describe based on the statutory definitions and requirements set forth in the Federal Food, Drug, and Cosmetic Act, as applied to the scientific data and other relevant facts concerning a particular product that are available to FDA when it receives an application for a particular product,” the letter says.