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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CHG Hospital Beds Inc - Close Out Letter 11/2/11

  

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

 

NOV 2 2011


Mr. Don Roussy
Chairman and CEO
CHG Hospital Beds, Inc.
153 Towerline Place
London, Ontario
Canada N6E 2T3


Dear Mr. Roussy:

Thank you for submitting your letter dated September 8, 2011, to the Food and Drug Administration (FDA) in response to the Warning Letter dated August 29, 2011.

The Warning Letter dated August 29, 2011, included a citation for failure of your firm to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR Part 803.17. Your firm's response dated September 8, 2011, included a revised MDR procedure. We have reviewed your revised MDR procedure entitled 2-30-007, Class A Complaints for FDA Medical Device Reporting,
approved September 8, 2011, and it appears to be adequate.

The intent of our review is to facilitate the appropriate and timely submission of complete Medical Device Reports (MDRs). Ultimately, the responsibility rests with CHG Hospital
Beds, Inc. to use its MDR procedure effectively to comply with the requirements of 21 CFR Part 803.

If you have any questions regarding this letter, please contact the MDR Policy Branch by email at MDRPolicy@fda.hhs.gov or by phone at 301-796-6670.

 

Sincerely yours,

/S/

Anastacia M. Bilek, Ph.D.
Director
Division of Enforcement A
Office of Compliance
Center for Devices and
         Radiological Health