| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
WARNING LETTER
Jeffrey R. Binder
CEO
Biomet. Inc.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581
JUL 27 2010
RE: Signature™ Personalized Patient Care system
Refer to GEN 0901195 when replying to this letter.
Dear Mr. Binder:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Signature™ Personalized Patient Care system in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website. www.biomet.com. for the Signature™ Personalized Patient Care system. The product is a device within the meaning of Section 201(h) of the Federal Food, Drug, and Cosmetic Act.
The Signature™ Personalized Patient Care system 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, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).
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 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is available through the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Office of Compliance requests that Biomet, Inc. 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. We remind you that only written communications are considered official.
Your response should be sent to:
Matthew Krueger
Chief, Orthopedic and Physical Medicine Devices Branch
Center for Devices and Radiological Health
WO 66, Room 3676
10903 New Hampshire Avenue
Silver Spring, MD 20903-0002
If you have any questions about the content of this letter please contact: Amy Skrzypchak at phone number (301) 796-5613 or fax number (301) 847-8138.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
No comments:
Post a Comment