CDRH Critical to Quality Initiative
August 1, 2018
Q2 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program
June 5, 2018
Update on CDRH Patient-Centered Initiatives
May 31, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Data Analysis
April 19, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews – Instrument Development
March 15, 2018
Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot program
February 27, 2018
From stories to evidence: Quantitative patient-preference information to inform product-development and regulatory reviews
February 15, 2018
Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
December 12, 2017
A Case Study in How Patient Preference Information Contributes to Regulatory Decisions for Medical Devices
December 4, 2017
Patient values and P-Values: Exploring a new method for developing patient-centered clinical trials
November 17, 2017
Virtual Patient R Code Access and Use
May 18, 2017
Leveraging Existing Information for Future Studies: The Case for Bayesian Methods
April 17, 2017
MDICx – Quality Metrics: Best Practices, Cases Examples and How Metrics Factor into the Case for Quality
April 6, 2017
MDICx: Draft Framework for Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – from the MDIC Clinical Diagnostics Surrogate Samples Working Group
April 5, 2017
Survey of Surrogate Sample Use in Clinical Diagnostic Test Development and Product Submission – Report from the MDIC Clinical Diagnostics Surrogate Samples Working Group
March 23, 2017
