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CDRH

米国FDAは、医療機器適合性評価認定プログラムパイロットの詳細を追加

このニュースのポイント:

  • 米国FDAは、今後の適合性評価のための認定スキーム(ASCA)パイロットプログラムについて、より多くの情報を提供しています。
  • ASCAには、医療機器に関する少なくとも5つのFDA認定の自主的合意基準が含まれます。
  • パイロットプラグラムは2020年9月までに開始予定です。

Obama’s 2012 Budget Includes 4.8% Increase for CDRH

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) would see an appropriation of $329 million—a 4.8% increase over current levels—in the Obama administration’s proposed 2012 budget. Total CDRH funding would total $395 million, with $66 million from industry user fees, if the administration has its druthers, according to The Gray Sheet .

CDRH Rolls Out 2011 Priorities

On the heels of revealing some of its 510(k) reform plans on January 19, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) medical device regulatory unit has published a list of its four strategic priorities for 2011--including taking a more assertive role in promoting development of products the unit deems necessary to combat public health challenges.