Course benefit
In order to avoid extremely costly delays, it is essential to understand the laws, regulations, processes and guidance for medical devices in order to be successful in getting medical devices into the US marketplace. There are several recent guidance documents which are key to effectively navigating FDA.

Participants will leave with a clear understanding of the basic laws, regulations, processes and guidance for oversight of medical devices in the US which is essential to successful device development, testing and applications. In particular they will have received a detailed discussion of several of the most recent and important guidance documents which impact how medical devices are regulated and affect a sponsor’s plans for developing medical devices and interacting with FDA.  

Course content
The course provides insight to several recently critical guidance documents relating to regulation of medical devices in the US: 
 

• De Novo 510(k)s
• Evaluating Substantial Equivalence for 510(k)s
• Updated Sterility Guidance
• Balancing Premarket and Postmarket Data for PMAs
• Regulation of Mobile Apps
• Communication During FDA’s Review of Submissions
• Pre-Submissions
• FDA IDE Decisions and Procedures
• Design of Pivotal Clinical Studies
• Emergency Research
• Clinical Trials Outside the US
• Fundamentals of Animal Studies
• Early Feasibility Studies
• Live Case Presentations at Scientific Meetings
• Leveraging Existing Clinical Data for Pediatric Indications

The course will be conducted in English.

Who should attend
Anyone who has an interest in development of medical devices intended for the US market.   

Instructors
H. Semih Oktay, PhD, Founder and President, CardioMed Device Consultants, LLC
Elisa D. Harvey, DVM, PhD, Senior Regulatory Consultant, CardioMed Device Consultants, LLC

"The presenter was very good. Online session worked excellently. Nice to get an understanding of the mindset in FDA - knowledge which is not really possibly to gain by reading articles" 

"Semih Oktay was very knowledgeable and an absolute plus that he was a former FDA employee"

"The presenter was very good. Nice to get an understanding of the mindset in FDA - knowledge which is not really possibly to gain by reading articles"

"Knowledgeable teacher with much experience within the subject" 

"Lots of relevant information was provided" 

Participants, Fall 2020