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FDA
Regulatory Approval Process workshop
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FDA Regulatory Approval Process Workshop
Available Dates:
No Dates currently available
Cost:
Option 1: $249 / per person
Option 2: $750 / per person
Location: Bose Corporation,Stow, MA |
There are no dates currently available.
Please contact us for more information regarding upcomng events. |
Medical device companies need FDA 510(k) clearance to market products in the United States. Companies need to evaluate the best regulatory path to bring their products to market in the U.S., what is needed to complete the 510(k) process, and when a 510(k) must be submitted.
Understand how to submit a successful Premarket Notification 510(k) Submission for a device or a device change as quickly and efficiently
as possible to avoid regulatory issues and unnecessary expenses. Make sure your 510(k) submission can be quickly reviewed and cleared by the FDA so you can stay ahead of the competition.
The topics covered in this workshop are:
- Overview of FDA’s regulatory classifications and requirements
- Primary routes to market: Premarket Approvals (PMAs), 510(k)s and exemptions
- Strategy and Planning
- Elements of the 510(k) and definitions
- 513(g) requests for designation
- Selecting a predicate – Substantial Equivalence and Scientific Validity
- General 510(k) principles on what to expect
- 510(k) structure—traditional, abbreviated, and special
- Modifications to devices and resubmission
- The FDA Review Process
- Marketing and postmarket responsibilities
- Objectives
- Introduction of the Premarket Notification 510(k) Submission
Process -- Understand the elements of premarket notification 510(k)
submissions for medical devices
- The Regulatory Landscape – PMA vs. 510(k)
- The Process - Learn what is expected and when a 510(k) is needed
Modifications - Understand when a device needs a new 510(k) submission
Labeling, Marketing and Postmarket Responsibilities - Know what your
responsibilities are after your device is on the market
Your instructors:
Kenneth Campanale and Lori Kahler:
Kenneth Campanelli, Director of Regulatory Affairs and Quality
Assurance, Iris International
IRIS International is a leading global in vitro diagnostics company
focused on products that analyze particles and living cell forms and
structures, or morphology of a variety of body fluids. The Company’s
products leverage its strengths in flow imaging technology, particle
recognition and automation to bring efficiency to hospital and
commercial laboratories.
Ken has had held similar positions in the medical device industry for
the past 20 years for such companies as CR Bard, Millipore and
Symmetry Medical. Ken has presented at ASQ Biomedical and MassMedic
workshops.
Ken is an adjunct professor at Northeastern U. where he teaches in the
Master of Science in Regulatory Affairs program.
Lori Kahler, Lori Kahler, President, The RC Insight Group
Lori Kahler joined The RC Insight Group in 2009. She was the Director of Quality and Regulatory
Affairs for Heartlab, LLC (acquired by Agfa-Gevaert) from 2000 to
2005. From 2005 to 2007, she was Global Director of Quality Assurance
and Regulatory Affairs of the Cardiovascular Business Unit for the
Agfa-Gevaert Group. Prior to her appointment at The RC Insight Group,
Kahler was Vice President of Quality Assurance, Regulatory and
Clinical Affairs for Ximedica, LLC from 2005 to 2007.
The RC Insight Group is a provider of regulatory and clinical consulting
services, competitive intelligence and strategic planning for the
medical device and biotechnology industry.
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