FDA Regulation of Medical Devices: Recent FDA Guidance Documents
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.
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.
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
- 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.
H. Semih Oktay, PhD, Founder and President, CardioMed Device Consultants, LLC
Elisa D. Harvey, DVM, PhD, Senior Regulatory Consultant, CardioMed Device Consultants, LLC
"The course speakers were very knowledgeable and quite happy to share their insights and answer questions"
"I liked the stringent logic in how to think regulatory strategy. Something I have missed in other presentations about FDA strategy"
"It was great to gain insight into the mindset of FDA reviewers and the process behind FDA regulations and guidelines from two former FDA employees"
"The instructor was able to tell more than what is in the guidelines; he gave a lot of references and ideas on how to handle interaction with the FDA and highlighted what had motivated the FDA with their different guidelines"
"It was very informative"
"Gave a clear overview of the processes and requirements"
Participants, Fall 2018