Inspections, Compliance, Enforcement, and Criminal Investigations
Airway Clearing Tools 15-Jul-04
Department of Health and Human Services
Public Health Service
Center for Devices and
Edward Manougian, M.D.
Airway Clearing Tools
1517 Summit Road
Berkeley, CA 94708
Dear Dr. Manougian:
The Food and Drug Administration (FDA) has learned from your firm's website, www.airwayclearingtools.com, that your firm is marketing the Airway Clearing Tool in the United States (U.S.) without marketing approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under the Act, the Airway Clearing Tool is considered to be a medical device because it is intended for use in the cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body. Airway clearing tools are Class III devices which may be marketed only after submission and approval of a premarket approval action. 21 CFR 874.5350.
A review of our records reveals that you have not obtained premarket approval for the Airway Clearing Tool. Consequently, the device is adulterated under section 501(f)(1)(A)(i) of the Act 21 U.S.C. 351 (f)(I)(A)(i) in that it is a Class III device which is required by regulation to have an approved application for premarket approval and which does not have such approval.
The device is also misbranded under section 502(o) of the Act [21 U.S.C. 352(o)] because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b).
You should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket approval for your device and does not necessarily address other obligations you have under the law.
Please let this office know in writing within fifteen (15) working days from the date you receive this letter what steps you are taking to correct the problem.
If you have more specific questions about how FDA marketing requirements affect your particular device or about the content of this letter, please feel free to contact Keisha Thomas at 301-594-4613.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and