Inspections, Compliance, Enforcement, and Criminal Investigations

Collagen Matrix Inc 1/8/15

  

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 

 

WARNING LETTER
 JAN 8, 2015
 
Shu-Tung Li, Ph.D.
President & CEO
Collagen Matrix, Inc.
15 Thornton Road
Oakland, New Jersey 07436
 
Re: Collagen Dental Wound Dressings
Refer to CMS #437174 
 
Dear Dr. Li:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Collagen Dental Wound Dressings in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Under section 201(h) of 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.
 
The FDA has reviewed your firm’s current website (http://www.collagenmatrix.com/products-woundcare.htm) and determined that the Collagen Dental Wound Dressings 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 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), for the devices as described and marketed.  The Collagen Dental Wound Dressings are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
 
Specifically, the Collagen Dental Wound Dressings were cleared under K122115 with the following indications for use: Collagen Dental Wound Dressings are intended for the management of oral wounds and sores, including:
  • Denture sores
  • Oral ulcers (non-infected or viral)
  • Periodontal surgical wounds
  • Suture sites
  • Burns
  • Extraction sites
  • Surgical wounds
  • Traumatic wounds
 
However, your firm’s promotion of the devices provides evidence that the devicescan be use to control minor bleeding, which would constitute a major change or modification to their intended use, for which your firm lacks clearance or approval. Examples include: 
  • “is an excellent hemostatic agent, which can be used to control minor bleeding.” 
During the review of K122115, your firm was specifically advised to remove any hemostatic claims and did so in order to obtain clearance. Please be advised that a hemostatic claim requires a premarket application that has been approved as a Class III device under 21 CFR 878.4490, which describes Absorbable Hemostatic Devices. 
 
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 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.
 
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 (which must address systemic problems) 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
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Avenue
Silver Spring, MD 20993
 
Refer to the identification number CMS #437174when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact:  Debra E. Demeritt, Chief, Surveillance and Enforcement Branch II, at telephone (301) 796-5770 or fax (301) 847-8128.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
 
 
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
    Radiological Health

 

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