※追記更新（2017.10.04）
※追記更新（2017.10.04）
10/2付で米国FDAから 、医療機器の申請と手数料に関わるガイダンス等が多数発出されています。
関係者にあっては、発出ガイダンス等をご確認ください。
●「User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM345633.pdf
●「User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM345931.pdf
●「User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff」のURLhttps://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM209858.pdf
●「User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff」のURLhttps://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM576306.pdf
●「FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff」のURL https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM576305.pdf
●「Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf
●「FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089738.pdf
●「FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089734.pdf
●「New CDRH Learn Module - Medical Device User Fee Amendments of 2017 (MDUFA IV): An Introduction」ウェブサイトのURL（サイト内のNew module 10/2/17を参照のこと）
https://www.fda.gov/Training/CDRHLearn/ucm126230.htm
【10/4付追記更新】
10/3付のRAPSが「FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions」と題して記事に取り上げています。
興味のある方は、下記URLのニュース記事をご参照ください。
http://www.raps.org/Regulatory-Focus/News/2017/10/03/28593/FDA-Issues-8-Guidances-on-Device-User-Fees-MDUFA-IV-Goals--Pre-Submissions/
【10/4付追記更新】
10/2付のMED DEVICE ONLINEが「7 Common Mistakes That Sink FDA 510(k) Clearance」と題して、関連の内容記事を掲載しています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.meddeviceonline.com/doc/common-mistakes-that-sink-fda-k-clearance-0001
※追記更新（2017.10.04）
10/2付で米国FDAから 、
関係者にあっては、発出ガイダンス等をご確認ください。
●「User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/
●「User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/
●「User Fees for 513(g) Requests for Information - Guidance for Industry and Food and Drug Administration Staff」のURLhttps://www.fda.gov/downloads/
●「User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff」のURLhttps://www.fda.gov/downloads/
●「FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff」のURL https://www.fda.gov/downloads/
●「Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/
●「FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/
●「FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff」のURL
https://www.fda.gov/downloads/
●「New CDRH Learn Module - Medical Device User Fee Amendments of 2017 (MDUFA IV): An Introduction」ウェブサイトのURL（サイト内のN
https://www.fda.gov/Training/
【10/4付追記更新】
10/3付のRAPSが「FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions」と題して記事に取り上げていま
興味のある方は、下記URLのニュース記事をご参照ください。
http://www.raps.org/Regulatory
【10/4付追記更新】
10/2付のMED DEVICE ONLINEが「7 Common Mistakes That Sink FDA 510(k) Clearance」と題して、
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.meddeviceonline.
執筆者について
経歴 ※このプロフィールは掲載記事執筆時点での内容となります
コメント
/
/
/
コメント