FDA warned spinal implant and surgical instrument developer Alphatec Spine that failing to meet mandatory post-market study requirements for three 510(k)-cleared spine devices makes the products misbranded under the law.

The agency cites Alphatec in a Jan. 11 warning letter for post-market study violations involving the firm's Zodiac DynaMo semi-rigid spinal system, Isobar semi-rigid spinal system and Isobar semi-rigid dual dampener.

Zodiac DynaMo was cleared for marketing in 2007, the Isobar dual dampener was cleared in 2008, and the Isobar spinal system was cleared in 1999. In October 2009, FDA used its authority under section 522 of the Food, Drug and Cosmetic Act to order Alphatec to conduct post-market surveillance on all three products.

FDA alerted Alphatec last July that its section 522 study protocol lacked information needed for FDA to complete its review. The agency later identified revisions or information the company needed to submit before its post-market surveillance plan could be approved.

According to the warning letter, the three Alphatec devices are misbranded because the firm failed to revise the post-market surveillance plan and address FDA's concerns within the specified timeframe. The firm now has 15 working days from Jan. 11 to submit a revised 522 study plan.

522 post-market surveillance studies are less common than traditional post-approval studies, which FDA can require as a condition of approval for any class III device. But FDA has said it is considering making greater use of 522 studies, where appropriate, because they carry a greater enforcement hammer, as failure to comply with the statute constitutes device misbranding. (See " Also see "FDA May Impose More "522" Studies As Post-Approval Enforcement Tool" - Medtech Insight, 31 August, 2009. " – "The Gray Sheet" Aug. 31, 2009.)

Letter Sends A Signal

According to Mary Beth Ritchey, an epidemiologist in the device center's Office of Surveillance and Biometrics and the 522 program lead, FDA has issued warning letters for failure to comply with 522 study obligations in the past. But "it is a fairly rare circumstance," she said.

"For a long time, FDA didn't spend a lot of resources enforcing this requirement," said Michael Gaba, a health care and regulatory attorney with Holland & Knight who focuses on devices. "They are now."

"They're sending a signal to the entire community that they need to pay attention and do what they're supposed to be doing," he said.

Section 522 studies can be imposed on class II and III devices that are life-sustaining or life-supporting; are implanted in the body for more than a year; have significant use in pediatric populations; or whose failure would likely lead to serious health consequences.

According to FDA's website, there are currently 35 ongoing 522 post-market surveillance studies and 114 ongoing device post-approval studies.

By Jessica Bylander

Rare Warning Letter Cites Alphatec For Post-Market Study Non-Compliance

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