Classification panel

Panels hold public meetings and their recommendations inform FDA decisions. For a new or controversial device type, a panel's discussion is often a useful early signal of how FDA may view it.

Classification panel means one of the several advisory committees established by the Commissioner under section 513 of the Federal Food, Drug, and Cosmetic Act and part 14 of this chapter for the purpose of making recommendations to the Commissioner on the classification and reclassification of devices and for other purposes prescribed by the Federal Food, Drug, and Cosmetic Act or by the Commissioner.

21 CFR, 860.3