Title:  Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data

Technology of Interest:  Craniomaxillofacial Distractors

Disease Area:  Dental

Duration:  9 months

Network Collaborator(s): PEDSnet

This test-case will assess the feasibility of using Real-World Data (RWD) captured through the NESTcc Data Network to conduct proactive post-market surveillance for safety with devices used in pediatric populations.
The European Union (EU) issued new Medical Device Regulations (MDR) in May 2017 that includes requirements for “proactive surveillance” for recertification of medical devices to remain on the market in the EU by May 2020. Companies that develop and manufacture medical devices will therefore need to develop methodology and approaches for proactive surveillance of medical devices that meets the EU’s MDR standards in order to keep medical devices accessible to patients in the EU.
The use of implantable devices is generally rare in pediatrics, and therefore the study of devices such as craniomaxillofacial (CMF) distractors requires multi-site collaboration. The low patient density, combined with significant per-site start-up costs, have made pediatric device studies difficult to execute.
This test-case seeks to determine the feasibility of using RWD captured through PEDSnet, a NESTcc Data Network Collaborator, to conduct proactive post-market surveillance for safety and effectiveness for CMF distractors.

Follow us @NESTccMedTech

The NESTcc call for Governing Committee member nominations, open to all stakeholders, has been extended. The deadline for nominations is now Tues, March 31. Read more about this opportunity: bit.ly/2VgygM3 pic.twitter.com/O13KVIQXl7 3 weeks ago

Data Network Director @robbert_z shares key learnings and value opportunities from our Test-Case projects in the latest NESTcc blog post. Read here: bit.ly/2QndKG4 pic.twitter.com/ztM2kBx1pV 3 weeks ago

National Evaluation System for health Technology Coordinating Center (NESTcc)
1501 Wilson Blvd., Suite 910, Arlington, VA 22209

© Copyright 2020 | Privacy Policy

An Initiative of:

MDIC logo

Follow MDIC:

Twitter logo
LinkedIn Logo