Attend this webinar to learn about when you require a premarket approval for a medical device and FDA approval process for medical devices.

1. When a Premarket Approval (PMA)
is Required
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2. Instructor Profile:
Ronald Schoengold is a consultant to the biotechnology, pharmaceutical and
medical device industry. He is a certified regulatory affairs professional and Fellow
of the Regulatory Affairs Professional Society. Ron provides advice on quality,
regulatory and product development issues, helping businesses effectively
commercialize and maintain their products and services. He has been an active
contributor to the industry for over 45 years and has developed commercially
successful pharmaceutical, screening and diagnostic products for GI medicine,
infectious disease and point-of-care testing. Ron is also an advisor to the Larta
Institute, an NIH supported group that assists young companies who receive SBIR
grants. He has published scientific journal articles and presented seminars and
webinars on scientific and current regulatory compliance topics. Ron also co-authored
a book chapter on point-of-care testing and holds 8 patents related to
point-of-care diagnostics. He earned his bachelor’s degree in biology and
chemistry, did his master’s training in microbiology and biochemistry, and
completed additional graduate studies in microbiology, genetics, molecular biology
and immunology.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

3. Description:
The decision to submit a PMA should be taken only after a comprehensive
review of existing technologies and similar marketed medical devices, previously
classified by the FDA. The starting point in deciding if a PMA is appropriate is a
comprehensive risk assessment of the device based on the intended uses and
indications for use. The PMA application and review is a multistep interactive
process that imposes substantial administrative requirements, protracted time
elements, and financial burdens on the submitter.
FDA utilizes the premarket approval (PMA) process to determine if Class III
devices are safe and effective based on objective scientific evidences. FDA defines
Class III devices as those that support or sustain human life, are of substantial
importance in preventing impairment of human health, or which have the
potential of unreasonable risk of illness or injury to an individual.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. Why Should you Attend:
Attend this webinar to learn about when you require a premarket approval for a
medical device. A PMA approval from FDA grants the submitter a private license to legally
market the device. The decision to submit a PMA should be taken only after an in depth
assessment of the potential business risks and rewards.
Objectives of the Presentation:
The objectives of the presentation are to discuss about:
• Historical PMA overview
• Classification of new or novel technologies and medical devices
• De novo route
• PMA timeline
• Pre-submission meetings with FDA
• Non-clinical studies
• Clinical investigations
• Foreign studies
• User fees
• Quality System requirements
• Value assessment
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Who can Benefit:
Regulatory & Quality Assurance Managers, Product Managers, Program Managers,
Research and Development
Live Session - How it
works
• Username and Password will be sent
to you 24 hours prior to the webinar
• Presentation handouts in pdf formate
will be mailed to you
• Login to the session using the
username and password provided to
you
• Get answer to your queries through
interactive Q&A sessions via chat
• Please let us know your thoughts and
views at the end of webinar, your
valuable feedback will help us
improve
• Get certification of attendance.
Recorded Session - How it
works
• A link will be provided to you upon
purchase of the recorded session
• Please click on the link to access the
session
• Presentation handouts in pdf formate
will be mailed to you
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. Reach us on :
www.onlinecompliancepanel.com
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links
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com