This webinar will present an overview of the regulation of in vitro diagnostic (IVD) devices in the United States, European Union and Canada. With a primary focus on IVD regulation by the US FDA, the webinar will cover the classification of IVD devices, an overview of data required for different submission types, and special topics.
The webinar will also cover the changes in regulatory oversight in the European Union, and will briefly touch on the regulation of devices in Canada, including recent changes related to oversight of the quality system in that country.
Why Should You Attend:
Small companies typically are unable to hire the necessary regulatory and quality staff to adequately understand the regulations in the US, EU and Canada and to have productive interactions with regulators.
Typically, these companies hire consultants to educate them on these regulations. For a small fee, the attendee of this webinar can obtain a broad overview of the IVD regulations in these three markets and bring back these concepts to their company.
The regulations governing the marketing of in vitro diagnostic devices (IVD) in the United States, European Union, and Canada are complex and in constant flux. This webinar will provide the attendees with a broad overview of how IVD devices are classified and reviewed by the US FDA.
The user will also understand how devices are classified in the EU and Canada, and understand the impact of changes to EU regulations. This webinar will be especially useful for leaders of emerging firms who are interested in developing and marketing IVD products in these markets.
Areas Covered in the Webinar:
- History of Food and Drug Law in the United States
- Classification of IVD devices in the US
- 510(k) premarket notification (US)
- Premarket approval (US)
- Presubmissions (US)
- Special topics – software as a medical device, CLIA waivers, companion diagnostics
- Device classification under the IVD Directive (EU)
- Transition from the IVD Directive to the IVD Regulation (EU)
- Classification of IVD devices in Canada
- Quality systems, including ISO 13485 and the Medical Device Single Audit Program
Instructor Profile:
Joshua D. Levin, Ph.D., RAC is a regulatory affairs and quality systems expert who has worked for a number of companies in the in vitro diagnostics (IVD) space (ASELL LLC, Personal Genome Diagnostics, and Digene) as well as research products companies (Life Technologies, KPL).
In between his stints in industry, Dr. Levin was a reviewer and postmarket team lead at FDA/CDRH with a primary focus on immunology, hematology, and molecular diagnostic products. Dr. Levin is also involved in freelance regulatory/quality consulting work and in educational projects through AAMI and ComplianceOnline.