9/24付で米国FDAから「The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」関係の最終ガイダンス並びに関連通知等が発出されています。
コンビネーション製品を含むむ医療機器における適合性評価のための認定スキームパイロットプログラムに関するものです。
また本件について、9/24付のRAPSが「FDA finalizes ASCA pilot guidance as it gears up for launch」と題して記事に取り上げています。
関係者及び興味のある方は、下記URLsの最終ガイダンス並びにニュース記事をご参照ください。
l最終ガイダンス「The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/130901/download
l最終ガイダンス「Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/142388/download
l最終ガイダンス「Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/142385/download
l最終ガイダンス「Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/142388/download
lウェビナー開催案内「Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances - October 22, 2020」
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-accreditation-scheme-conformity-assessment-asca-pilot-program-final-guidances-10222020
l更新ウェブサイト「Accreditation Scheme for Conformity Assessment (ASCA)」
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-scheme-conformity-assessment-asca#terminology
l9/24付RAPS「FDA finalizes ASCA pilot guidance as it gears up for launch」
https://www.raps.org/news-and-articles/news-articles/2020/9/fda-finalizes-asca-pilot-guidance-as-it-gears-up-f
コンビネーション製品を含むむ医療機器における適合性評価のため
また本件について、9/24付のRAPSが「FDA finalizes ASCA pilot guidance as it gears up for launch」と題して記事に取り上げています。
関係者及び興味のある方は、下記URLsの最終ガイダンス並びに
l最終ガイダンス「The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/
l最終ガイダンス「Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/
l最終ガイダンス「Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/
l最終ガイダンス「Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program」
https://www.fda.gov/media/
lウェビナー開催案内「Webinar - Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidances - October 22, 2020」
https://www.fda.gov/medical-
l更新ウェブサイト「Accreditation Scheme for Conformity Assessment (ASCA)」
https://www.fda.gov/medical-
l9/24付RAPS「FDA finalizes ASCA pilot guidance as it gears up for launch」
https://www.raps.org/news-and-
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