Tuesday, January 11 2011
FDA WARNING : Zodiac DynaMo Semi-Rigid Spinal System, ISOBAR Semi-Rigid Spinal System, ISOBAR Semi-Rigid Dual Dampener,
JAN 11 2011
Paula Morgan, RAC
The Food and Drug Administration (FDA) cleared under premarket notification your Zodiac DynaMo Semi-Rigid Spinal System (K072081), ISOBAR Semi-Rigid Spinal System (K991326), and ISOBAR Semi-Rigid Dual Dampener (K071261). On October 5, 2009, FDA ordered your firm to conduct postmarket surveillance of your Zodiac DynaMo Semi-Rigid Spinal System, your ISOBAR Semi-Rigid Spinal System, and your ISOBAR Semi-Rigid Dual Dampener, in accordance with section 522 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC § 360l, and 21 CFR Part 822.
On July 30, 2010, FDA notified you that after evaluating your section 522 postmarket surveillance study protocol, FDA concluded that your submission lacked information needed to complete the review. FDA listed the deficiencies with your protocol and required a complete response within 30 days. On September 10, 2010, FDA issued a follow-up letter stating that FDA had not received your section 522 postmarket surveillance study protocol and required the overdue postmarket surveillance study plan within 14 days.
After FDA issued the approvable letter identifying the specific revisions or information that must be submitted before your plan can be approved, you failed to revise your postmarket surveillance submission to address the concerns in the approvable letter and submit it to FDA within the specified timeframe, under 21 CFR 822.19(b). Under section 502(t)(3) of the Act, 21 USC § 352(t)(3), your devices are misbranded because you failed or refused to comply with any requirement under section 522 of the Act, 21 USC 360l.
You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct this violation 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 note that Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Within fifteen (15) working days from the date you receive this letter, please submit your section 522 postmarket surveillance study plan that addresses the deficiencies identified in the July 30, 2010, letter, and notify this office in writing of the specific steps you have taken to correct the noted violation. 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.
Your study plan and response to this letter should be sent to:
Attention: Mary Beth Ritchey, RN, MSPH, PhD
If you have any questions about the content of this letter please contact: Mary Beth Ritchey at 301-796-6638 (telephone) or 301-847-8140 (fax).
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of postmarket surveillance requirements for your devices and does not necessarily address other obligations you have under the law.
Steven D. Silverman