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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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LifeNet Health

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

DEC 2, 2010
 

WARNING LETTER

VIA UNITED PARCEL SERVICE & FACSIMILE

Mr. Michael Plew
Vice President of Quality and Regulatory Compliance
LifeNet Health
1864 Concert Drive
Virginia Beach, VA 23453

RE: MatrACELL™ Pulmonary Artery Patch Allograft

Dear Mr. Plew:

Refer to CMS #128430 when replying to this letter

The Office of Compliance (OC), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) has reviewed your July 27, 2010 response to our letter, dated July 14, 2010, regarding promotional claims made for the MatrACELL™ Pulmonary Artery Patch Allograft (MatrACELL™ Allograft). FDA has determined that your response is inadequate and that your firm is marketing the MatrACELL™ Allograft in the United States (U.S.) for a new intended use without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

FDA reviewed your website, http://www.lifenethealth.org, for the MatrACELL™ Allograft on July 14, 2010. The MatrACELL™ Allograft is a device within the meaning of Section 201(h) of the Act, 21 U.S.C. 321(h), 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 are intended to affect the structure or function of the body. 
 
As we noted in our letter dated July 14, 2010, your promotional materials, which appear on your website at http://www.lifenethealth.org, promote the MatrACELL™ Allograft for the claim of “reduced immune response.” FDA cleared your premarket notification (510(k)) for the MatrACELL™ Allograft, K081438, for repair of the right ventricular outflow tract. However, the MatrACELL™ Allograft has not been cleared for the claim of “reduced immune response.”  This claim represents a major change or modification in the intended use of your device that requires a new premarket notification. 21 CFR 807.81(a)(3)(ii).
 
The MatrACELL™ Allograft is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do 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(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for the new intended use discussed above, as required by sections 510(k) of the Act, 21 U.S.C. 360(k) and 21 CFR 807.81(a)(3)(ii).
 
FDA requests that LifeNet immediately cease marketing the MatrACELL™ Allograft for unapproved uses such as those described above.  You should take prompt action to correct these violations.  Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and /or civil money penalties.
 
We suggest LifeNet Health contact the Peripheral Vascular Devices Branch, Office of Device Evaluation at (301) 796-6376 to discuss the submission of a premarket notification (510(k)) for any proposed new intended use of the MatrACELL™ Allograft.
 
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing what steps you have taken to correct the problem and how you plan to prevent this from happening again. Please list all promotional materials for MatrACELL™ Allograft containing claims for unapproved uses such as those described above, and explain your plan for discontinuing use of such claims.  Please direct your response to Daniel G. Walter, Acting Chief, Vascular & Circulatory Support Devices Branch, Division of Enforcement B, WO66, Room 3678, Office of Compliance, at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, facsimile at (301) 847-8139.  We remind you that only written communications are considered official.
 
The violations discussed in this letter do not necessarily constitute an exhaustive list.  It is your responsibility to ensure that your promotional materials for MatrACELL™ Allograft comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiologial Health