GCP Device Refresher

Identifies investigator responsibilities in clinical investigations and discusses federal regulatory requirements and international guidelines for investigational trials of devices. It also identifies what documents and reports are due to the U.S. and international regulatory authorities, and describes the role of a sponsor-investigator in a clinical investigation of a medical device.

Recommended Use: Required
ID (Language): 17205 (English), 19838 (Finnish), 19844 (French), 19856 (German), 19850 (Chinese), 17362 (Spanish)
Author(s): Daniel Redline, BA - Align Technology, Inc.

Describes the U.S. regulatory requirements for various classes and categories of medical devices and explains the differences between significant risk (SR), non-significant risk (NSR), humanitarian, and exempt medical devices.

Recommended Use: Required
ID (Language): 17206 (English), 19839 (Finnish), 19845 (French), 19857 (German), 19851 (Chinese), 17363 (Spanish)
Author(s): Daniel Redline, BA - Align Technology, Inc.

Discusses the international standards that address GCP for the design, conduct, recording, and reporting of clinical investigations of devices involving human subjects to assess their safety and/or performance. Further, it describes the ISO 14155:2011 GCP standard and compares the ISO 14155:2011 GCP standard to the FDA regulations.

Recommended Use: Required
ID (Language): 17207 (English), 19840 (Finnish), 19846 (French), 19858 (German), 19852 (Chinese), 17364 (Spanish)
Author(s): Daniel Redline, BA - Align Technology, Inc.

Describes the general requirements for obtaining and documenting informed consent, including orally without obtaining a signature on the consent form. It also describes the exception to the requirements for emergency use and emergency research and to the requirements for investigations of in vitro diagnostic assays.

Recommended Use: Required
ID (Language): 17208 (English), 19841 (Finnish), 19847 (French), 19859 (German), 19853 (Chinese), 17365 (Spanish)
Author(s): Daniel Redline, BA - Align Technology, Inc.

Covers the oversight of clinical investigations of medical devices in the U.S. and internationally.

Recommended Use: Required
ID (Language): 17209 (English), 19842 (Finnish), 19848 (French), 19860 (German), 19854 (Chinese), 17366 (Spanish)
Author(s): Daniel Redline, BA - Align Technology, Inc.

Explains the reporting requirements of 21 CFR 812 (the FDA regulations for the conduct of clinical investigations of devices) and International Organization for Standardization (ISO) 14155:2011 - Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice (the international standard for the conduct of investigations of devices).

Recommended Use: Required
ID (Language): 17210 (English), 19843 (Finnish), 19849 (French), 19861 (German), 19855 (Chinese), 17367 (Spanish)
Author(s): Daniel Redline, BA - Align Technology, Inc.