FDA Approval Process for Medical Devices 20 (London, United Kingdom - September 16-17, 2020) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "FDA Approval Process for Medical Devices 20" conference has been added to ResearchAndMarkets.com's offering.

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the general controls applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications. Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the pre-submission process, which FDA strongly recommends to help ensure the successful submission of novel devices.

Demonstrations of how to find key information in FDA databases will be presented using participants' products and interests as examples. There will also be updates on recent legislation changes, new regulations and guidance documents.

Please note that while the law, regulations, principles and processes covered in the course apply to both medical devices and in-vitro-diagnostics (IVDs), the trainer's primary experience is with medical devices.

Benefits of attending

Upon completion of this seminar, participants will:

• Understand the overall FDA medical device regulatory process
• Know what is required for 510(k), IDE, PMA, HDE and De Novo applications
• Understand how FDA processes premarket submissions
• Identify key guidance documents to help ensure a successful process
• Determine when pre-submission interaction with FDA is recommended
• Be aware of areas of change

Agenda:

Overview of US Medical Device Regulatory Principles

• FDA mission and organization
• FDA Center for Devices and Radiological Health (CDRH)
• History and law
• Device classification
• General controls
• Special controls
• Product codes
• Registration and listing
• 513(g) process
• e-Copy program
• MDUFA (Medical Device User Fee Act)
• Review performance goals
• Finding information in FDA databases
• 21st Century Cures legislation, FDARA and MDUFA IV

Pre-Submissions

• Types of pre-submissions
• Contents of a pre-submission
• Review timelines
• Preparing for an FDA meeting
• Dos and don'ts

510(k) process (Premarket Notification)

• History and purpose of 510(k) process
• Traditional, Special and Abbreviated 510(k) submissions
• Contents of 510(k) applications
• Substantial equivalence decision-making process
• 510(k) review processes
• Acceptance screening of 510(k)s (Refuse to Accept policy)
• Review timelines
• Interactive review processes
• 510(k) decisions
• When a new 510(k) is needed for a device modification

De Novo Applications for Low-Moderate Risk Devices

• De novo reclassification process
• Potential pros and cons of seeking de novo reclassification
• Contents of De novo applications
• De novo decision-making process
• Review timelines

Investigational Device Exemption (IDE) for Clinical Investigations

• Significant risk, non-significant risk and exempt investigations
• Contents of IDE applications
• IDE review timelines
• IDE decision-making process
• FDA actions on IDE applications
• 5-day notices
• IDE supplements
• Annual reports
• Sponsor responsibilities

Premarket Approval (PMA) for Class III Devices

• Content of PMA applications
• PMA review standard
• Acceptance screening and filing of PMAs
• Phases of PMA review
• Review timelines
• Advisory panel review
• Interactive review processes
• PMA decisions
• PMA supplements
• PMA reports
• Post-approval requirements

Humanitarian Device Exemptions

• Humanitarian Use Designation (HUD)
• HDE review standard
• Contents of HDE applications
• HDE review timelines
• HDE supplements
• HDE reports

Speakers:

Jonathan Hughes

J.Hughes

Jonathan Hughes, Ph.D., FTOPRA, has over 32 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic - device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.

For more information about this conference visit https://www.researchandmarkets.com/r/1oowlp