BioElectronics Corporation 1/31/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
January 31, 2012
VIA UPS EXPRESS AND FACSIMILE
Mr. Andrew Whelan
President and CEO
4539 Metropolitan Court
Frederick, Maryland 21701
Re: ActiPatch, RecoveryRx, and Allay
Dear Mr. Whelan:
The Food and Drug Administration (FDA) has learned that your firm is marketing the ActiPatch, RecoveryRx, and Allay products in the United States (U.S.) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance, in the Center for Devices and Radiological Health (CDRH), reviewed your firm’s websites at www.actipatchstore.com, www.allaystore.com, www.actipatch.ca, and www.bielcorp.com. Under section 201(h) of the Act, 21 U.S.C. § 321(h), the products noted above, which are sold on these sites, are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Your firm currently has an FDA-cleared premarket notification (510(k)) for the ActiBand device, K022404, which was cleared on August 8, 2002. The indication for use (IFU) statement for your ActiBand device is, “for the treatment of edema following Blepharoplasty.”
Your websites and device labeling for the ActiPatch, RecoveryRx, and Allay products include the following claims that FDA considers to be outside of the IFU for your 510(k)-cleared ActiBand device. These claims represent major changes or modifications in the cleared intended use of the ActiBand device, under 21 CFR 807.81(a)(3)(ii).
- “ActiPatch . . . BACK PAIN THERAPY” (www.bielcorp.com, www.actipatchstore.com, www.actipatch.ca, device package, and device package insert)
- “ActiPatch . . . WRIST PAIN THERAPY” (www.bielcorp.com, www.actipatchstore.com, www.actipatch.ca)
- “ActiPatch . . . KNEE PAIN THERAPY” (www.bielcorp.com, www.actipatchstore.com, www.actipatch.ca)
- “ActiPatch works to relieve your heel pain . . . .” (www.actipatch.ca)
- “ActiPatch . . . Pain in your elbow? Gone.” (www.bielcorp.com)
- “ActiPatch . . . increases blood flow and re-establishes normal cell interaction.” (www.bielcorp.com, www.actipatch.ca, device package, and device package insert)
- “ActiPatch is a revolutionary . . . treatment for overnight relief of:
• chronic pain
• inflammation” (www.bielcorp.com and device package)
• chronic wounds” (www.bielcorp.com)
- “ActiPatch quickly relieves inflammation, edema, and pain.” (www.bielcorp.com, www.actipatchstore.com, www.actipatch.ca, and device package insert)
- “By placing the ActiPatch directly onto the injured tissue the microchip can deliver an equivalent dosage of a full size pulsed diathermy device. . . . Cumulative absorbed energy at the skin level is equivalent to traditional high power devices. Effect of continuous delivery provides greater therapeutic benefit.” (www.bielcorp.com)
- “Indications for Use . . . .
■ Breast Plastic Surgery
■ Rhinoplasty” (www.bielcorp.com)
- “RecoveryRx is directed towards . . . suppressing the vasodilatory response.” (www.bielcorp.com)
- “RecoveryRx . . . Reduces Swelling, Bruising, & Pain.” (www.bielcorp.com)
- “RecoveryRx . . . Accelerates The Natural Healing Process.” (www.bielcorp.com)
- “RecoveryRx Surgical Recovery Kit” (www.bielcorp.com)
- “Allay . . . Menstrual Pain Therapy” (www.bielcorp.com, www.allaystore.com, and device package insert)
- “Allay Reduces Pain & Swelling” (www.bielcorp.com)
- “Allay . . . quickly relieve edema, inflammation, and pain…” (www.bielcorp.com)
- “Allay . . . to lessen contractions and alleviate the pain and discomfort resulting from menstruation.” (www.bielcorp.com)
- “Allay is a . . . solution to eliminate your menstrual pain and discomfort . . . .” (www.bielcorp.com)
- “The Allay . . . is a revolutionary . . . treatment for pain and discomfort associated with menstruation.” (www.bielcorp.com)
- “Allay is a pulsed electromagnetic field therapy device. . . . When the wire loop is placed near your skin, an undetectable magnetic field pulses into your tissue and activates the cells in the swollen tissue. Once activated, the cells re-establish cell to cell communication and begin to pump fluid out of the spaces in your tissue. This fluid removal reduces your bloating, water weight, pain, and swelling associated with menstruation.” (www.bielcorp.com)
- “BioElectronics . . . has developed an innovative delivery mechanism . . . optimized for treatment of pain and edema at the source.” (www.bielcorp.com)
- “Allay . . . [to] alleviate your . . . discomfort resulting from menstruation.” (device package insert)
- “Benefits of Allay • Treats Pain and Swelling [Edema] at the Source” (device package insert)
A review of our records reveals that you have not obtained marketing authorization before you began offering the above-noted devices for sale. You submitted premarket notifications for the Allay device on April 30, 2010, for the ActiPatch device on July 22, 2010, and for the RecoveryRx device on April 6, 2011. CDRH determined that the ActiPatch, (b)(4) are “not substantially equivalent” (NSE) to any legally-marketed devices. In (b)(4) CDRH’s NSE decision letters, CDRH stated that, “Any commercial distribution of this device prior to approval of a PMA, or the effective date of any order by the Food and Drug Administration re-classifying this device into class I or II, would be a violation of the Act.”
These devices 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 approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The kind of information that your firm needs to submit in order to obtain marketing authorization for the devices 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 products may be legally marketed.
Furthermore, the ActiPatch and Allay devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for these devices fails to bear adequate directions for use for the purpose for which they are intended. Your cleared ActiBand device, K022404, is a prescription device, as described in 21 CFR 801.109. As a prescription device, the ActiBand “is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.” 21 CFR 801.109(a)(2). In addition, as a prescription device, the label of the ActiBand must bear the statement: "Caution: Federal law restricts this device to sale by or on the order of a ____" – the blank to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the state in which he practices to use or order the use of the device. 21 CFR 801.109(b)(1). The ActiPatch and Allay devices, were they cleared, would likewise be required to be sold as prescription devices with required cautionary statements. However, these products are being sold on your firm’s websites, www.actipatchstore.com and www.allaystore.com, without requiring a prescription or other order of a practitioner. CDRH was able to order the ActiPatch BACK PAIN THERAPY device from www.actipatchstore.com and the Allay device from www.allaystore.com, without your firm requiring a prescription or other order from a licensed practitioner. Moreover, the labels of these devices fail to bear the above-quoted cautionary statement.
The Office of Compliance requests that BioElectronics immediately cease the dissemination of labels, labeling, and promotional materials for ActiPatch, RecoveryRx, and Allay devices bearing claims the same or similar to those described above. Importantly, you may not market your devices for any intended use that is outside your 510(k) clearance, "For the treatment of edema following Blepharoplasty," K022404, unless you have first obtained appropriate marketing authorization.
You should take prompt action to correct these violations. 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/or 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 submit a written response to this letter within 15 working days from the date your firm receives this letter, describing your intent to comply with this request, listing all labels, labeling, and promotional materials for the ActiPatch, RecoveryRx, and Allay devices, the same or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, at 10903 New Hampshire Avenue, WO66 Rm # 2609, Silver Spring, MD 20993. If your firm has any questions about the content of this letter please contact: Matthew Krueger at 301-796-5585, facsimile at 301-847-8139. We remind your firm that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your firm’s responsibility to ensure that the ActiPatch, RecoveryRx, and Allay devices comply with each applicable requirement of the Act and FDA implementing regulations.
Steven D. Silverman
Office of Compliance
Center for Devices and