Description and Learning Objectives:
In the presentation we will learn about two important FDA permissions: 1) Investigational Device Exemptions (IDEs) for clinical trial approval, and 2) 510(k) and PMA market applications for product commercialization.

FDA brings a risk-based assessment to approval for clinical trials. By viewing clinical trials as exempt, non-significant risk, and significant risk, FDA applies an increasing level of regulation as the medical risk to the subjects increase. Understanding how risk is assessed and how it can be lessened or increased by a selective choice of words, claims, and intended use may enable you, as a sponsor, to position the investigational device in the IDE category that best suits your business needs.

The pathway for commercialization is more situational based. The choice between a 510(k) premarket notification and a PMA premarket application was originally based on the newness of the technology or whether or not the investigational device was substantially equivalent to a pre-amendment (pre May 1976) device. Today, the extent to which an existing device is changed from the original with regard to safety, efficacy, or intended use effects which kind of 510(k) will be required. Only for totally new technologies does risk become the deciding factor, dictating either a de novo 510(k) or a PMA will be required.

Understanding how incremental changes in devices effect the regulatory options available may enable you to manipulate the type of application required.

The learning objective is to understand the differences between the three major types of FDA permissions—IDEs, 510k, and PMAs—as a basis for understanding medical device regulations.

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:
1) One computer connection for one learner
2) Printable PowerPoint slides with notes
3) IDE Outline
4) An FDA Approved IDE.
5) GHTF Clinical Evaluation Guide
5) Three FDA GUidances on 510(k)
6) A searchable pdf file of 2007 warning letters
7) A graded quiz with immediate test results
8) Certificate of Attendance and 0.4 CEUs.

Who should attend:
[x] Clinical research professionals who work with regulations.
[x] Regulatory professionals.
[x] Managers and decision-makers.
[x] Executives for start-up companies.
[x] DSMB and CEC members.
[x] Investigators for medical device trials.
[x] Marketing professionals wha want to understand the effect of their claims.