Inspections, Compliance, Enforcement, and Criminal Investigations
American Bio Medica Corp 7/30/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|10903 New Hampshire Avenue
Silver Spring, MD 20993
VIA FEDERAL EXPRESS
JUL 30, 2009
American Bio Medica Corporation
c/o Mr. Stan Cipowski
122 Smith Road
Kinderhook, New York 12106
Dear Mr. Cipowski:
Based on a recent review of your website, www.abmc.com. the United States Food and Drug Administration (FDA) has determined that your firm is marketing an over-the-counter (OTC) test system, OralStat, for drugs-of-abuse testing in oral fluid. FDA has determined that you are marketing this OTC test system without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Your website states:
• "OralStat combines the convenience of oral fluid collection with the sensitivity, accuracy and precision of a laboratory based test providing results in about 16 minutes."
• ABMC's website states that OralStat is "For Forensic Use Only." However, ABMC issued a press release on July 30, 2008, announcing that ABMC had shipped an order of OralStat to Save Mart to improve the food store chain's drug testing program. "We are confident that the OralStat will enhance Save Mart's existing drug testing program and allow them to continue to see the practical and economic advantages of point of collection drug testing."
• ABMC also issued another press release on October 11, 2005, announcing that the San Francisco Fire Department "selected ABMC to be their sole provider of drug testing devices and support services" and would use the OralStat test for "post-accident and random drug testing of their 1,600 firefighters."
In our September 20, 2008, letter to you, we included the OralStat test as one of the tests that you were marketing for which we could not identify any FDA clearance number or approval number. Subsequently, in a telephone call with you regarding the letter, you stated that the OralStat test was "For Forensic Use Only." However, the above statements indicate that you are marketing this test to the public for use in workplace settings.
Under section 201(h) 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt to obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records reveals that you have not obtained marketing clearance before you began offering this product for sale, which is a violation of the law. Specifically, the above referenced device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) 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, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the Agency, 21 C.F.R.807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Mr. James Woods, Deputy Director, Patient Safety and Product Quality, Office of In Vitro Diagnostic Devices, Evaluation and Safety, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. If you have any questions about the content of this letter please contact Mr. Robert Fish, Consumer Safety Officer, at (301)796-6144.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Alberto Gutierrez, Ph.D
Office of InVitro Diagnostic Device
Evaluation and Safety
Center for Devices and Radiological Health