Source: https://www.casewatch.net/fdawarning/prod/2010/bioveda.shtml
Timestamp: 2019-04-23 14:22:42+00:00

Document:
During an inspection of your firm located in Boca Raton, Florida on December 30, 2009 through January 8, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the BAX3000. 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 is intended to affect the structure or function of the body.
Our inspection revealed that the BAX3000 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(0) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of your firm's intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
"Are you tired of suffering needlessly from red runny noses, fatigue, headaches, migraines, sinus pressure, wheezing, coughing, sneezing, indigestion, unsightly rashes such as eczema, Rosacea, and psoriasis?"
"I did not get my usual reaction to poison ivy after this treatment."
"Bax 3000 successful in treating pet dander allergy.[sic]"
" ...patient who has struggled with life-long allergies - which are no longer an issue after BAX 3000 Neurological Stress Reduction Therapy."
"Find news and press releases on NSRT [(Neurological Stress Reduction Therapy)] and how it can help normalize behavior among children with ADD, ADHD, Autism and Asperger's Syndrome."
"Find news and press releases about substance specific stressors that trigger digestive problems including IBS and how the symptoms can be alleviated through NSRT."
All of the above claims are new and significantly different from the intended use, relaxation training of the Digital Conductance Meter device cleared as a biofeedback device in submission (b)(4).
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 your firm needs 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.
The BAX3000 is also misbranded under Section 502(o), 21 U.S.C. § 352(o), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510, 21 U.S.C. § 360; was not included in a list required by section 510(j), 21 U.S.C. § 360(j); or a notice or other information respecting the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k).
Our inspection also revealed that your firm's BAX3000 devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, your firm's failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
A follow up inspection will be required to assure that corrections are adequate.
Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407)475-4731.
1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm failed to establish complaint handling procedures to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting.
2. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm failed to demonstrate that the device's instruction manual was approved prior to distribution to the end users.
This page was posted on November 17, 2010.

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