Somatic Reference Samples RFI Q&A

April 4, 2019

Overview of the CDRH 510(k) Improvement Project

April 4, 2019

MDICx: Clinical Dx Somatic Reference Samples Landscape Analysis

March 6, 2019

MDICx: Q4 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

December 6, 2018

MDICx: Cybersecurity for Medical Devices – Advancing Coordinated Vulnerability Disclosure

November 20, 2018

MDICx: Somatic Reference Samples Prioritized Variants Public Comment Period – from the MDIC Clinical Diagnostics Somatic Reference Samples Working Group

November 8, 2018

Q3 Quarterly update on the CDRH Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program

September 12, 2018

Designing patient-centered clinical trials: Results of the MDIC project to use patient preference information to design clinical trials

August 15, 2018

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