APEC Regulatory Harmonization Steering Committee (RHSC)
Results
Consultation
RPS Table of Contents Pilot, Regulated Product Submission Working Group, Coordinator Patrick Axtell
US Food and Drug Administration (FDA), Closed Tuesday, 20 March 2018.
Consultation
RPS - Common Data Elements for Medical Device Identification, Regulated Product Submission Working Group, Coordinator Nancy Shadeed, Closed 15 September 2015.
Consultation
Request for expressions of Interest to participate in the IMDRF TOC pilot plan, Regulated Product Submission Working Group, Coordinator Patrick Axtell - US Food and Drug Administration (FDA), Closed Friday, 21 August 2015.
Consultation
Regulated Product Submission - Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions, Regulated Product Submission Working Group, Coordinator Nancy Shadeed, Closed 1 June 2015.
Consultation
In-Vitro Diagnostics Market Authorization Table of Contents, Regulated Product Submission Working Group, Coordinator Patrick Axtell - US Food and Drug Administration (FDA), Closed Friday, 17 January 2014.
Consultation
Regulated product submission (RPS) Table of contents, Regulated Product Submission Working Group, Coordinator Patrick Axtell - US Food and Drug Administration (FDA), Closed Friday, 21 June 2013.
Consultation
Software as a Medical Device (SaMD): Clinical Evaluation, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 13 December 2016.
Consultation
Software as a Medical Device (SaMD): online survey now open, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Monday, 3 August 2015.
Consultation
Software as a Medical Device (SaMD): Application of Quality Management System, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel, Closed 01 June 2015.
Consultation
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls, Software as a Medical Device (SaMD) Working Group, Coordinator Bakul Patel - US Food and Drug Administration (FDA), Closed Saturday, 31 May 2014.