Inspections, Compliance, Enforcement, and Criminal Investigations
Pulse Health LLC 9/28/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
September 28, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-36
Christopher L. Marsh, CEO
Pulse Health, LLC
1331 NW Lovejoy Street, Suite 765
Portland, Oregon 97209
Dear Mr. Marsh:
During an inspection of your firm located in Portland, Oregon, on May 29, 2012, through June 8, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the REVELAR device. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (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.
Our inspection revealed that the REVELAR device 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 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 REVELAR device is 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 device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). Specifically, your firm’s Support Guide makes the following claims:
- “Revelar can accurately assess free radical damage and improve the health of your patients.”
- “When there is an abundance of free radicals in our bodies, the genetic code material of cells can be changed, and this will result in mutations that can lead to aging and serious conditions such as leukemia, other forms of cancer, and chronic degenerative diseases.”
- “Free radicals, in excess, have been linked to increased risk of many chronic diseases. Revelar measures the amount of internal tissue damage from free radical activity and assigns a number or ‘score’ to the result, a personal Revelar Score or Rev Score. With initial testing you get a snapshot of the level of tissue destruction taking place in the body, as well as establishing a baseline for future testing comparisons.”
Additionally, your firm’s website, available at www.myrevelar.com/science/revelar, makes the following claims about the REVELAR device:
- “Testing for free radical damage is an important indicator of potentially severe health problems. Excess free radicals lead to free radical damage that has been linked to problems such as rapid aging. Revelar is a breakthrough in accurate measurement of free radical damage through a non-invasive, breath testing system that looks for free radical damage in patients. Revelar ultimately helps doctors make effective preventative health care recommendations. Elevated levels of free radical damage can contribute to a host of health problems. Free radical activity can result in tissue damage that potentially leads to chronic conditions such as arthritis, cancer, diabetes, strokes, Alzheimer's disease as well as rapid aging.”
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/DeviceRegulation andGuidance/ 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 registration and listing requirements.
Therefore the REVELAR device is misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(0), in that the device was 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).
We acknowledge receipt of your written response dated June 26, 2012. Your response is inadequate because it fails to specify how your firm will correct the noted violations. In addition, we acknowledge in your response that your firm is not currently selling the REVELAR device or disseminating marketing material, and that your firm intends to submit a 510(k) for version two of the REVELAR device prior to marketing. The adequacy of this response cannot be determined at this time.
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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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.
Your firm’s response should be sent to: Food and Drug Administration, Attention: Brenda L. Reihing, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021. If you have any questions about the content of this letter, please contact Brenda L. Reihing at (425) 302-0429 (telephone) or (425) 302-0402 (fax).
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. The specific violations noted in this letter may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Charles M. Breen