At The Intersection Of Quality And Metrics: What’s Ahead In FDA’s Effort To More Objectively Measure Quality

Recommendations from the MDIC Case for Quality Working Group on Medical Device Quality Metrics made headline news in the latest FDANews/International Devices & Diagnostics Monitor (Courtesy of International Devices and Diagnostics Monitor, FDAnews) and the Gray Sheet. Read how the CfQ Metrics pilot project landed on three metrics that span the product lifecycle.

July 11 JAMA Editorial

FDA Commissioner Robert Califf and CDRH Center Director Jeff Shuren speak to the need for a National Evaluation System for Health Technology in a July 11 JAMA Editorial. Learn more about this important topic at MDIC’s Annual Public Forum September 21 in Washington, DC.

Contrived / Surrogate Samples (CSS) Use Survey is open

MDIC’s Contrived / Surrogate Samples (CSS) Use Survey is open. Currently, the speed at which innovative and improved diagnostics are developed can be hampered by the difficulty in obtaining clinical specimens. The use of contrived / surrogate samples can foster innovation when clinical specimens are difficult to obtain. This survey will take approximately 15 minutes to […]

Medical Device Innovation Consortium Announces Release of Draft Blueprint for Early Feasibility Study Success

MDIC releases draft Blueprint for Early Feasibility Study Success. As shared in a recent article, MDIC members are already realizing the strategic value of US-based EFS.

Would-Be FDA ‘Maturity Model’ Pilot Might Reward Firms With Delayed Inspections

Gray Sheet article (paid content) on FDA’s potential pilot program to delay inspections based on a manufacturer maturity model. As a part of Case for Quality, FDA may allow device manufacturers to put off inspection for a few years if independent verification of robust quality metrics are in place.

Draft Blueprint for US Early Feasibility Study Success.

MD+DI article highlights MDIC’s release of a draft Blueprint for US Early Feasibility Study Success. Article features an interview with MDIC EFS working group chair Karim Benali.

Incorporating Patient Preferences into Medical Device Benefit-Risk Assessments

A team of authors from the MDIC Patient Centered Benefit Risk Steering Committee had an article published online in the Journal of Biopharmaceutical Research on incorporating patient preferences into medical device benefit risk assessment.

CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality

Gray Sheet article on CDRH’s 2016-17 strategic priorities cites CDRH’s involvement with the MDIC PCBR Framework as part of CDRH’s commitment to integrating patient perspectives into regulatory decision making

CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality

The Gray Sheet published an article titled, “CDRH Prioritizes Leveraging Real-World And Patient-Preference Data, Enhancing Quality,” citing CDRH’s 2016-17 strategic priorities.  These priorities include involvement with the MDIC PCBR Framework as part of CDRH’s commitment to integrating patient perspectives into regulatory decision making