Department of Health and Human Services
|Public Health Service|
|Office of the Commissioner|
5600 Fishers Lane
Room 14-105, HF-7
Rockville MD 20857
|Food and Drug Administration|
Rockville, MD 20857
May 28, 1992
Re: Request for Designation for SonoRx
Our Pile RFD: 92-12
We have completed our review of the above-referenced request for a product jurisdiction determination, accepted for filing on April 8, 1992.
SonoRx is an orally administered ultrasound product c containing simethicone and cellulose. The product is intended to [redacted ]. After considering the you have conferring with the two affected centers, I am designating the Center for Drug Evaluation and Research (CDER) as the agency component with primary jurisdiction for the premarket review and regulation of the product. We also have determined that your product will be regulated under the new drug provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355; 21 C.F.R. Part 314). Any clinical trials conducted to support a new drug application for the product must be conducted in accordance with the investigational new drug regulations in 21 C.F.R. Part 312.
The Division of Medical Imaging, Surgical and Dental Drug Products in CDER will be the primary reviewing division. For further information, please contact Ms. Susan Kummerer at (301) 443-3560.
Please note that you may request reconsideration of this designation decision under the provisions of 21 C.F.R.§ 3.8(c). A request for reconsideration must be submitted within 15 days of your receipt of this letter.
If you have any questions concerning this matter, please do not hesitate to telephone me or Acting Deputy, Steve Unger at 301-443-1306.
Amanda B. Pedersen
Product Jurisdiction Officer