The National Medical Device Curriculum is a set of four fictitious case studies intended to help academic institutions and medtech companies understand FDA’s medical device regulatory processes. The FDA believes that better understanding of regulatory processes will accelerate the delivery of innovative medical devices to patients.
The first, entitled “Regulatory Pathways for Medical Devices: Choosing the Right One” is intended to set the scene by describing the steps a new company may follow to bring its first product, an insulin pump, to market.
The aim of this study is:
- To review the fundamental concepts of premarket regulatory activities of medical devices in the United States.
- To apply the regulatory concepts to an infusion device.
- To identify the available regulatory pathways for medical devices.
The second study, “Freedom From Unacceptable Risk: Making a Case for Safety Assurance and Risk Management” , deals with an infusion pump company considering risk assessment and mitigation.
The learning objectives are:
- To review the regulatory background of the safety assurance case.
- To identify fundamental concepts of safety assurance for medical devices.
- To explore how a risk management framework may support a safety assurance case.
- To apply the framework to risk assessment and risk control for an infusion device.
The third study is called, “Bringing an Innovative Device to Market: Premarket Approval (PMA) of Medical Devices”, and covers regulatory issues raised when bringing a bare metal coronary stent device to market through the Premarket Approval (PMA) regulatory pathway.
This study’s learning objectives are:
- To introduce the medical device First in Human (FIH) Investigational Device Exemption (IDE) Application.
- To introduce the medical device PMA.
- To understand the steps to obtain a PMA application and its data requirements.
- To examine the general principles of nonclinical and clinical investigations.
The final study, “An innovative “Me-Too” Idea: Premarket Notification - 510(k) Medical Device Submissions” describes a hip implant company seeking to market a medical device that it believes is substantially equivalent to a Class II medical device and thus eligible for the Premarket Notification (510(k)) regulatory pathway.
Learning Objective(s):
- To understand the “substantial equivalence” decision-making process for a 510(k) submission.
- To examine the 510(k) submission processes as a whole.
- To prepare a traditional 510(k) (a write-up of key sections of a submission) in a team project.
To me, the 80s soap opera style jars but there is no doubt that the information is clear and well laid out – if you have the recommended three hours to spend going each one. The following excerpt from case study one gives you a flavour…
“…And we’ll need to make sure the postmarket surveillance controls are in place, like Medical Device Reporting, which includes tracking of adverse events. Then we go to market with your device!”
Neyhard held up one hand. “Stop right there.”
Mooney and Laws shifted nervously in their seats. What had they missed?
To be continued…
Whitehall Trainings' course, Device Safety & Vigilance, was written by Steve Jolley - a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signalling).
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