Does your medical device qualify for an investigational device exemption (IDE)? What does this process involve and what does FDA expect of these manufacturers? There is plenty to consider when it comes to the IDE timeline and process.

In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill “Mr. Regulatory” who sheds valuable light on the topic of IDE, which allows an investigational device to be used in a clinical study to collect safety and effectiveness data, and how to navigate this process in an efficient and compliant manner.

• FDA has a few programs to consider when it comes to safety and significant risk or not for products. High-risk devices could fall into a non-significant risk study.
• Exempt or not? Make sure to provide sufficient information to identify significant or not risks based on objective evidence. 
• COVID-19 issues prompted FDA to post guidance on statistical considerations, confounding factors, and remote monitoring for IDE and clinical studies.
• When does FDA require an IDE? If it’s a new device category or significant departure from the existing technology, FDA will probably need clinical data.
• All PMA devices do not require an IDE. Also, a device that follows the 510(k) path does not require clinical data, but an IDE may be requested with a clinical study for marketing submissions and reimbursement. 
• The contents of an IDE application must include 12 items, such as the name and address of the sponsor; a complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan; and a description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and installation of the device.
• Within 30 days, the FDA is expected to give a decision on the submission. The study will be approved, approved with conditions, or disapproved.

“Everybody wants to be breakthrough, but not everybody is breakthrough.” 

“There are a lot of clinical studies that are just exempt from IDE regulations.”

“Even high-risk devices could fall into a not significant risk kind of a study.”

“There’s always a chance that the FDA is going to disagree with you, if you think it’s non-significant risk. FDA is going to lean, in general, towards a slightly more conservative judgement on gray area issues.” 

“Specifically, if it’s a new sort of category of device or a significant departure from the existing technology, you’re probably going to need clinical information.”

David Pudwill (Mr. Regulatory) on LinkedIn

Mr. Regulatory Website

Mr. Regulatory on YouTube

FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Investigational Device Exemption (IDE)

FDA - IDE  Basics

Podcast - An Introduction to FDA’s Regulation of Medical Devices

Premarket Approval (PMA)

Premarket Notification 510(k)

De Novo Classification

Humanitarian Device Exemption (HDE)

Breakthrough Devices Program (BDP)

Early Feasibility Studies (EFS) Program

EFS Breakthrough Device Designation 

Safer Technologies Program (STeP)

Center for Devices and Radiological Health (CDRH) Learn

Institutional Review Boards (IRB)

Significant Risk vs. Non-Significant Risk for Medical Devices

21 CFR Part 812

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru