Page 235, insert after line 2 the following new subtitle: Subtitle R--Other Provisions SEC. 2321. STUDY ON TWO-TIERED APPROVAL PROCESS FOR DEVICES BY FDA.***.

Purpose:

An amendment numbered 7 printed in House Report 114-193 to direct the Food and Drug Administration to issue a report on the risks and benefits associated with a two-tiered approval process that would permit certain medical devices to provisionally come to market if they have demonstrated safety but not efficacy.

House Amendment Code:

(A007)

House Tally Clerks use this code to manage amendment information.