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 »

Articles in

Regulatory Decision

Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)

Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson’s Disease (PCOR Project Aim 1 Paper)

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...

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

MDIC created a “How-To” video series 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...

Video Release of MDIC’s Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials

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

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)

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...

Best Practices for Communicating Benefit, Risk, and Uncertainty for Medical Devices Report

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...

A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology

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...