A growing body of literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC’s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson’s...
Total Product Life Cycle : Regulatory Decision Phase
If the clinical studies yield sufficient information on a device’s safety and effectiveness, the sponsor can submit an application to FDA to market the device to the public. There are several types of applications, depending on which class of device is being developed.
If appropriate, FDA can consult an Advisory Committee at a public meeting. FDA Advisory Committees consist of groups of experts who provide FDA with independent advice on whether a product should be approved or not. After the Advisory Committee meets, FDA decides about the approvability of the device or request additional information. By law, FDA must publish its decision with all supporting evidence in the Federal Register.
Read about the Total Product Life Cycle here »
Regulatory Decision
MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials
MDIC created a “How-To” video to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations from the...
Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials
In conjunction with its release of the Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials, MDIC issued a short video in which several experts involved in writing the report, including a patient who uses a medical device patient,...
MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials Report
This report provides a series of resources to help sponsors maximize patient input in their design and development of clinical trials. In particular, the report offers a series of best practices for device sponsors to identify and engage the “patient voice.” By...
Parkinson’s Patients’ Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study (PCOR Project Aim 2 paper)
A growing literature has developed identifying outcomes that matter to patients. The study that these published articles (Aims 1, 2 & 3 of MDIC’s PCOR project) are based on demonstrates an approach to identifying outcomes of medical devices for Parkinson’s disease...
Literature Review: Patient Engagement in Clinical Trials
As the field of patient engagement in medical product development continues to expand, it can be difficult to find useful resources and materials in this area. MDIC undertook a comprehensive literature review in 2019 and 2020 to compile the most relevant information...
Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report
MDIC designed this report to be a practical resource to help professionals across the medical device community discuss medical device benefits, risks, and uncertainty in easy-to-understand language. While investigators, physicians, regulators, and others involved in...
Case Study: Using the MDIC Patient Centered Benefit-Risk Framework to Support an Expanded Indication
Some patients may require dialysis if their own bodies are unable to filter toxins from their blood. Hemodialysis is a type of dialysis in which blood is pumped from the body through a filter and then back into the body. Typically, in-clinic treatment requires...
Patient Centered Outcomes Research (PCOR) Project Workshop
In May 2018, MDIC convened a public workshop to review and discuss the outcomes from MDIC’s Patient Centered Outcomes Research (PCOR) project. The workshop featured presentations and panel discussions involving experts from across the medical device ecosystem,...
A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology
The Patient Centered Benefit-Risk (PCBR) Framework introduces the concept of the total product development lifecycle and discusses how patient preference information might be useful at each stage of this lifecycle. The report provides background on the concepts of...