Investigational Device Exemption Workshop

19 August 2009

Learning Objective
The learning objective of this workshop is to understand the differences between exempt, significant risk, and non-significant risk devices; exempt, significant risk, and non-significant risk studies; and no-IDE, abbreviated-IDE, and full-IDE approvals to implement the studies.

Study Permissions
In the United States, the regulation of medical device clinical trials is risk-based, and permission to implement a trial is obtained in one of three ways: 1) through a full IDE process for significant risk devices in which FDA reviews the protocol and approves the IDE application, 2) through an abbrviated IDE process for non-significant risk devices in which the IRB acts as FDA's surrogate and reviews and approves the protocol, or 3) by nature of the device's status of already being commercial no prior approval is required by FDA for study implementation.

Significant Risk Devices or Significant Risk Studies--Full IDEs
Devices are defined as significant risk in 21 CFR 812.3(m) where, among other things, we read that implants, life-supporting or life-sustaining devices, or devices substantially important for diagnosing, curing, mitigating, treating, or preventing impairment of humans are considered significant risk. FDA's "Information Sheet Guidance for IRBs..." tells us that risk determination is based on the proposed use of a device in an investigation, and not on the device alone. This means that the investigation of a device that is non-significant in risk, in and of itself, may be regulated as significant risk if there are features of a study that expose human subjects to significant risk.

Exempt Studies--No IDE Required
Certain clinical trials are exempt from regulation as described in 812.2(c). Part 812 does not apply to to devices in commercial distribution before 28 May 1976 or devices in commercial distribution after 28 May 1975 under an approved 510(k), if used according to approved labeling, for example. And Part 812 does not apply to diagnostic devices if the device or sampling is non-invasive. So some clinical studies escape regulation by FDA; a prudent device manufacturer does most of their clinical studies under this category, if possible.

Non-significant Risk Devices--Abbreviated IDEs
All other devices are non-significant risk and clinical investigations may be conducted under an abbreviated IDE. With an abbreviated IDE, only IRB approval is necessary to conduct the study--in fact, FDA has no knowledge of the conduct, number, or nature of non-significant risk device investigations but CDG estimates that ~500 are conducted every year.

What We Will Learn
In this workshop we will review the characteristics of devices (and studies) that qualify them as significant risk. We'll look at who makes the regulatory determination about significant or non-significant risk and how you can expedite the process by anticipating the decision.

Next we'll look at the characteristics of devices (and studies) that qualify them for exempt status. We'll also discuss what other regulations do apply to these studies and under what circumstances.

Then we'll examine the differences in reporting requirements for significant and non-significant risk studies and whether or not it is advisable to limit yourself to these 30-year-old regulations.

In the final and major part of the workshop we'll discuss obtaining approval for the IDE application. Should you meet with FDA for a pre-IDE meeting and, if so, how do you prepare? Then we'll look at the contents of an IDE and review a format that meets FDA needs yet islogical to work with. Finally we'll look at why FDA returns with questions on 70% of IDE submissions and how you can be proactive to get first-round approval. If this is your first-time submitting an IDE, you'll appreciate the handout of a real, FDA approved, IDE.

A quiz, of course
The four-hour workshop is following by a half-hour online quiz, taken on your own time within the following two weeks. The quiz is designed to test your learning of the concepts discussed in the lecture and your ability to apply those concepts to real-life issues.

Course level
This is an intermediate level course. Participants are expected to have a basic knowledge of clinical research and device regulations.

You will receive
[x] One computer connection for one learner (each learner must log-in individually).
[x] Printable PowerPoint slides with notes.
[x] IDE Outline.
[x] An FDA approved IDE.
[x] Chart comparing the requirements of abbreviated and full IDEs.
[x] A graded quiz with immediate test results.
[x] Certificate of Attendance and 0.5 CEUs.

Who should attend
[x] Regulatory professionals who submit IDEs to FDA.
[x] Regulatory professionals who decide on the approval-level required for clinical studies.
[x] Clinical research professionals implement clinical studies.
[x] IRB members who are assigned to become device experts.
[x] Managers and decision-makers.
[x] Executives for start-up companies.
[x] Investigator-sponsors for medical device trials.

Instructor
The workshop will be taught by Nancy J Stark, PhD. Dr. Stark has over 25 years experience in device trials, serves as the US co-chair to ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects, was identified as one of 100 Notable People in Medical Devices by Medical Device & Diagnostics Industry magazine, and serves on the Editorial Advisory Board of MD&DI. You can learn more about her at Nancy J Stark.  

System requirements, date, time, registration
All you need is a personal computer, internet connection, and a telephone. The workshop will be presented on Wednesday, 19 August 2009, at 11:00 am Central Daylight Time. Event materials will be distributed the day before the workshop. Sign up at registration.

Tuition:
$500 per first learner.
$195 per additional learner.
$75 for late quiz!
See registration and cancellation policies.