Why did ReGen hire a lobbyist to assist with its 510(k) submission process?
ReGen hired a lobbyist after the FDA rejected the company’s second 510 (k) submission, applying an illegal review standard as grounds for its determination. This action took place long after the FDA had agreed that the company was eligible to submit for clearance through the 510(k) process. However, the Agency continued to reject the company’s attempts to obtain clearance multiple times, issuing a moving target of objections. The company had no practical option but to turn to its Congressional representatives to ensure a fair and appropriate review process at the FDA. The company had become the victim of commonly reported and well-documented internal dissension at the FDA between review staff and management. By law, the FDA is required to review 510(k) submissions within 90 days. Prior to retaining a lobbyist, ReGen had already worked for more than two years to try to obtain a fair review of its device.
