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Ex-CDRH Compliance Leaders And Regulatory Experts Offer Tips For Surviving Face-To-Face Meeting With FDA

This article was originally published in The Gray Sheet

Executive Summary

From our digital archives: When device manufacturers fail to prepare for FDA meetings, they miss a golden opportunity to exchange ideas, have their viewpoints heard and gain advice from agency staffers, former CDRH compliance officials maintain. If a firm didn’t come to a meeting prepared, “then it felt like we wasted our time because now we had to have another meeting or communication round to try to get to the issues,” says Larry Spears, a one-time deputy director of regulatory affairs in the device center’s compliance office. While FDA can call for its own “regulatory meetings” with manufacturers, most face-to-face meetings are requested by firms looking for advice or feedback from the agency after landing in hot water. Experts also discuss the importance of companies taking the right people to meetings.

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