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When a Premarket Approval (PMA) is Required

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

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When a Premarket Approval (PMA) is Required

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  1. When a Premarket Approval (PMA) is Required www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  2. Instructor Profile: Ronald Schoengoldis 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 pdfformate 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 pdfformate 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 Our links www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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