Inspections, Compliance, Enforcement, and Criminal Investigations
The Reynolds Office of Health and Nutrition 8/8/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
AUG 8, 2013
VIA UNITED PARCEL SERVICE
Sue and Michael Reynolds
The Reynolds Office of Health and Nutrition
P.O. Box 591,
Goleta, California 93116
Re: Hyperbaric Chamber Accessories
Refer to Case # 406279 when replying to this letter.
Dear Mr. and Mrs. Reynolds:
The United States Food and Drug Administration (FDA) has learned that your firm is marketing hyperbaric chamber accessories in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 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 to affect the structure or any function of the body.
The Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed the website “http://www.reynoldsoffice.com/” and found that your firm markets the following hyperbaric chamber accessories:
- Oxygen Concentrator - 5 psi
- Oxygen Concentrator - 8 psi
- Oxygen Concentrator - 15 psi
The information on your firm’s website indicates that the listed products are used with or for hyperbaric chambers. Hyperbaric chambers are Class 2 devices under Title 21, Code of Federal Regulations, Part 868.5470, which require submission of an application for clearance under section 510(k) of the Act, 21 U.S.C. § 360(k). Because the products are accessories to a Class 2 device, they also require submission of an application for clearance under section 510(k) of the Act.
The listed products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The products are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the products 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) 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/MedicalDevices/ DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to annually register with the FDA. In September, 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act, 21 U.S.C. § 360(p)] during the period beginning October 1st, and ending December 31st, of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2013. Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
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 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 Carl Fischer at the Food and Drug Administration, White Oak Building 66, Rm 3526, 10903 New Hampshire Ave., Silver Spring, MD 20993, facsimile at 301-847-8138. 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 your firm’s violations. 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 your firm’s products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and