Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
December 6, 2012
Philip E. Muccio
6111 Jackson Road
Ann Arbor, Michigan 48103-9167
Dear Mr. Muccio:
During an inspection of your firm located in Ann Arbor, Michigan on June 18, 2012, through July 25, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrical stimulation garments sold under the trade name Wearable Therapy. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products 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 to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b).
For example, it was noted during the inspection that you and the graphic designer would discuss projects verbally without documenting design plans for the Wearable Therapy garments including the Plexus Arm Sleeve (Upper Extremity BioSleeve) and the Lumbar BioBelt devices.
2. Failure establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, your firm does not have written design change procedures for making changes to Wearable Therapy Garments. Your firm redesigned and replaced the double sided silver lycra fabric with coated flexible wires as the conducting component in the Wearable Therapy Devices (Plexus Arm Sleeve and Lumbar BioBelt) but these activities were not adequately documented before their implementation.
3. Failure to establish and maintain adequate procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).
For example, your firm does not have written design transfer procedures or written documentation to support the design transfer of the Wearable Therapy devices including the Plexus Arm Sleeve (upper Extremity BioSleeve) and Lumbar BioBelt. You and the graphic designer discuss projects verbally, but you did not document design transfers.
4. Failure to adequately develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).
For example, your firm does not have written device manufacturing procedures for its Wearable Therapy garments including the Plexus Arm Sleeve (the Upper Extremity BioSleeve) and Lumbar BioBelt.
5. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
For example, several devices were released from your firm without a release signature and date to show that the release of the device was authorized by a designated individual. The devices that were released include the BioBelt Lumbar device with Serial Number (b)(4) , the Plexus Arm Sleeve device with Serial Number (b)(4), the and the BioBelt Lumbar device with Serial Number (b)(4).
6. Failure to adequately maintain device master records (DMRs) and to ensure that each DMR is prepared in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
For example, your firm’s DMR for Wearable Therapy garment devices lacks the following:
a. The DMR lacks the production process specifications for your current design including the appropriate equipment specifications, production methods, production procedures, and production environment specifications that describe how to assemble the Plexus Arm Sleeve (Upper Extremity BioSleeve) and Lumbar BioBelt devices. Your firm’s DMR for the AxioBionics Upper Extremity BioSleeve states that “work instructions are in the design file, but they are for the previous design.” Your firm’s work instructions for the BioBelt state that the work instructions were “found in the incomplete Waist Belt Ver. 1, 04/04/11, document.”
b. The DMR lacks the labeling specifications, including the methods and processes used for the printing of fabric labeling, for The Plexus Arm Sleeve (Upper Extremity BioSleeve) and Lumbar BioBelt devices.
7. Failure to document the label and labeling used for each production unit, lot, or batch in the DHR, as required by 21 CFR 820.120(d).
For example, an exact copy of your firm’s fabric label containing the device’s serial number, care instructions, and manufacturer information was not maintained or referenced in the DHR.
Our inspection revealed that your device no longer uses double sided silver lycra fabric as the conducting component between the stimulator and the cutaneous electrodes. The device now uses flexible coated wires as the conducting component and new electrodes that were not included in the 510(k).
We also note that your firm is promoting and marketing your Wearable Therapy devices without required marketing clearance or approval, in violation of the Act. When there are significant changes or modifications in the design, components, method of manufacture, or intended use of a cleared device, a new application must be submitted under section 510(k) of the Act, 21 U.S.C. § 360(k) and cleared prior to marketing [21 CFR 807.81(a)(3)].
Your firm (formerly Bioflex, Inc., Electromedicine) obtained clearance for “Bioflex Garments, Assorted Models” (K944543) under section 510(k) with the following medical indications:
“relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion.”
During the inspection, FDA obtained copies of your Upper Extremity NeuroProsthesis Wearable Therapy System instruction manual and brochures for your devices and has determined that your firm is promoting and marketing your Wearable Therapy Systems for uses that have not received required premarket clearance or approval by FDA. For example, your Upper Extremity NeuroProsthesis Instruction Manual and brochures contain the following claims:
“Description of the Upper Extremity Neuroprosthesis
“The Axiobionics UE NeuroProthesis is a customized medical device that manages and treats muscle paralysis affecting the upper extremity in patients with central nervous system disorder or injury.”
As an NMES device:
• Immediately after surgery
As an FES device:
•Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient’s gait.
As a TENS device:
• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain.
“Treatment of the Hemiplegic Patient
“When treated with the Upper Extremity Neuro-Prosthesis, the hemiplegia patient may have less spasticity and a more relaxed arm.”
“Reduces activity-related pain, perhaps allowing return to productive work or physical recreation”
In addition, FDA recently reviewed your firm’s website, www.wearabletherapy.com, and found the following claims for Axiobionic’s devices:
• “Indicated in Patients with:
○Traumatic Brain Injury
○Spinal Cord Injury
• “The NMES signal invokes a powerful inhibition to pain by blocking and preventing the pain signal from reaching the brain.”
• “One aspect of the Axiobionics …is that it can, in many cases, hold the level of pain down and not let it rise with a rise in activity of the body part in pain.”
• “. . .while medications may lower pain, they sometimes don’t keep it low when activity ensues. This alone may be the difference between a poor quality of life and one that is more fulfilling, including a return to gainful employment.”
• “Pain patients often live many years suffering needlessly – and the medical care received is often ineffective and costly. The Wearable Therapy System has resolved these issues for many of the most severe cases.”
During the review of K944543, your firm was advised that only the intended uses that are appropriate for your electrode garments are those acceptable claims for the different stimulators your garments are intended to be used with. You were also advised that we were not aware of data to support the claim for muscle spasticity or treatment of motor disorders. In response, you agreed to remove all claims from the labeling that were not consistent with the allowable claims for the various stimulators.
The claims made in your instruction manual, brochures and on your website represent changes in the intended use of your device. In addition, the significant modifications to the composition and design of the device may affect the safety or effectiveness of the device and change the intended use of the device.
As a result of these significant changes to the design and the intended use, the Wearable Therapy System 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 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). 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.
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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected.
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: Detroit District Office. Refer to the Unique Identification Number CMS Case #353558 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer Vaughn at 313-393-8297.
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 and in the Inspectional Observations, FDA 483, issued at the close of the inspection 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.
Glenn T. Bass
Detroit District Office