When a Premarket Approval (PMA) is Required

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When a Premarket Approval (PMA) is Required
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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 bachelors degree in biology and
  chemistry, did his masters training in
  microbiology and biochemistry, and completed
  additional graduate studies in microbiology,
  genetics, molecular biology and immunology.

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• 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. 

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• 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

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Who can BenefitRegulatory 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
  QA 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.

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www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com