FDA 101: A Primer on IDEs - Clinical and Translational Science Institute - University at Buffalo
The 3 Stages For Medical Device Clinical Investigation Explained
With results of pivotal study, AppliedVR to seek FDA clearance - MedCity News
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA | Trials | Full Text
![Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram](https://www.researchgate.net/publication/350164644/figure/fig1/AS:1021236666703872@1620493203303/Design-of-the-pivotal-Study-311-19-and-Study-312-13-20-phase-3-clinical-trials.png "Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram")
Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram
Study: 10% of FDA approved drugs since 2018 had pivotal trials that missed primary endpoints | RAPS
FDA Approves RECOVER IV Randomized Controlled Trial with Exception from Informed Consent (EFIC) | DAIC
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA | Trials | Full Text
Endotronix Announces FDA Approval for PROACTIVE-HF Pivotal Trial Design Change to Single-Arm Study - Lumira
Metavention's Renal Denervation Pivotal IDE Study now Approved by FDA for the Treatment of Hypertension
Approval Process
Summary of pivotal study designs for evaluating the efficacy of human... | Download Table
Clinical Trial Phases Explained: The Ultimate Guide | Power
Early Feasibility Studies for Cardiovascular Devices in the United States: JACC State-of-the-Art Review - ScienceDirect
Major pivotal study leads to FDA approval of the Vivistim Paired VNS System for treatment of upper limb impairments after chronic ischemic stroke | VJNeurology
Early feasibility studies in the United States: Focus on electrophysiology - Weiss - 2023 - Journal of Cardiovascular Electrophysiology - Wiley Online Library
Attachment E CDRH Final Guidance Cover Sheet
The use of external controls in FDA regulatory decision making - UC Berkeley Public Health
FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Non-Comparative Clinical Outcome Studies | RegDesk
Research Milestones — Tufts CSDD
PQ Bypass Announces Unconditional IDE Approval from U.S. FDA for Pivotal Study. - Seroba Life Sciences
Real-Time Oncology Review | FDA
Early phase clinical trial played a critical role in the Food and Drug Administration–approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021 - ScienceDirect
Ongoing and Upcoming Studies
