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National Evaluation System For health Technology Coordinating Center (NESTcc) Releases a R

By Business Wire

Business Wire
Overall Rating

NESTcc’s Active Surveillance Program for Medical Devices takes the next step

ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced today it released a Request for Proposal as part of an ongoing collaboration between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) that focuses on the Central Data Operations Hub as part of its Active Surveillance Program for medical devices:

RFP 23-AS1001: NESTcc Medical Device Active Surveillance – Central Data Operations Hub

NESTcc and the FDA intend to develop and implement an active surveillance system of electronic health data to better understand the safety of medical devices as used within clinical practice. Once realized, such a system will optimize data collection, quality, completeness, and analysis within a comprehensive framework to assess potential and ongoing safety signals in a timely manner. The active surveillance program is focused around achieving better data capture, detection of potential safety signals, and a timely assessment leading to actionable findings. In addition, the data structure developed for the active surveillance system will be viable for generation of real-world evidence fit for purpose for regulatory decisions.

Key Dates for the RFP:

Key Dates

Request for Proposal Released

July 17, 2023

Deadline for Questions

July 21, 2023

Indication of Interest

July 26, 2023

Responses to Questions

July 31, 2023

Deadline for Proposals

August 28, 2023

Projected Notification of Interest in Presentation

September 1, 2023

Presentation of Proposals

September 11-12, 2023

Projected Notification of Selection Date

September 18, 2023

Projected Start Date

September 30, 2023

More details regarding this RFP including how to respond may be found on the NESTcc website under “Open Calls”. Please send questions to NESTcc@mdic.org using the subject line “RFP 23-AS1001”.

About the National Evaluation System for health Technology Coordinating Center

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to break down barriers in the medical technology life cycle to accelerate innovation and adoption of safe, effective, and high-quality medical technologies. The consortium brings together medical technology manufacturers, researchers, regulators, payers, patients, and health care providers as trusted collaborators to solve complex challenges in the scientific and technical disciplines that propel medical technology development, approval, adoption and access. MDIC’s work improves regulatory pathways, advances medical device quality, enhances patient safety and access, and facilitates the development of better evidence for approval, coverage and utilization decisions. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.


Contacts

Todd West
twest@mdic.org

First published on Tue, Jul 18, 2023

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