Alveologic LLC 4/11/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
April 11, 2013
VIA UNITED PARCEL SERVICE
President and CEO
120 White Plains Road, 2nd Floor
Tarrytown, New York 10591
Refer to CPT1200608 when replying to this letter.
Dear Mr. Way:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Propel System device in the United States. The product is a device within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. As explained below, this device is being marketed without the required clearance or approval in violation of the Act.
On February 6, 2013, the Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed your firm’s internet web site at: http://www.propelorthodontics.com/doctors/about-us/ for the Propel System and found the following claim: “This procedure, developed by university researchers, called Alveocentesis, stimulates alveolar bone when orthodontic force is applied to teeth. As a result, bone is remodeled more efficiently, which can reduce treatment time by 60% or more.”
The Propel System device, promoted with the intended uses described above, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have for 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices 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 is deemed satisfied when a PMA is pending before the agency, 21 CFR § 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
The Office of Compliance requests that your firm immediately cease marketing the Propel System device for unapproved uses such as those described above. Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps that your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Please direct your response to Ronald L. Swann at the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, Maryland 20993, facsimile at 301-847-8137. We remind you that only written communications are considered official.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the product into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and
233 South Highland Avenue
Ossining, New York 10562