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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

FDA Response Letter to Pyng Medical Corporation Warning Letter

DEC 21, 2004

Kevin J . O'Neill
Pyng Medical Corporation
#7 - 13511 Crestwood Place
Richmond, BC V6V 2E9, Canada

Dear Mr. O'Neill,

We are acknowledging your response, dated December 1, 2004, to our November 24, 2004 response letter. Included in your current response is an updated Medical Device Reporting (MDR) procedure. We have completed our review of your response and have listed our comments below in the order addressed in your letter of December 1, 2004. The specific language from our November 24, 2004 letter has been included for clarity.

1. Section 6.6 of your MDR procedure states that "MDR event files shall be maintained for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device ". This statement should conclude with the statement "whichever is greater".

Your firm's response appears to be adequate. Specifically, your firm responded by submitting a revised MDR procedure, which now includes the statement "whichever is greater" in section 6.6.

Your firm's response to the April 9, 2004 warning letter now appears to be adequate; however, the corrective actions implemented by your firm will need to be verified by our investigator during the next inspection. If you have any further questions regarding this correspondence, please contact me by phone at (240) 276-0115, by facsimile at (240) 276-0114, or write to the letterhead address.

Sincerely yours,

/s/
Carolyn Niebauer
Chief
General Hospital Devices Branch
Division of Enforcement A
Office of Compliance
Center for Devices and Radiological Health