H.Amdt.662 to H.R.6114th Congress (2015-2016)
Description: H.Amdt. 662 — 114th Congress (2015-2016)All Information (Except Text)
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.***.
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.
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