DUBLIN, October 4, 2016 /PRNewswire/ --

Research and Markets has announced the addition of the "FDA Approval Process for Medical Devices" conference to their 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.

Benefits of Attending

- Know how the FDA is organized

- Learn how to determine the classification of your device

- Demystify the 510(k) clearance process

- Understand the de novo and other options when there is no predicate device

- Determine when FDA approval is needed for a clinical study

- Learn how to obtain an IDE for an investigational device

- Navigate the PMA approval process

- Plan for a pre-submission meeting with the FDA

- Understand the FDA's review performance goals and time frames

Agenda

Programme Day One

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)

Pre-Submissions

- Types of pre-submissions

- Contents of a pre-submission

- Review timelines

- Preparing for an FDA meeting

- Do's and don'ts

510(k) Process (Pre-market 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

- Appeal mechanisms

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

Programme Day Two

Investigational Device Exemption (IDE) for Clinical Investigations

- Early feasibility, pilot and pivotal studies

- Significant risk versus non-significant risk 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

- Contents 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

Potential Hot Topics

- Unique Device Identifier (UDI)

- Medical Device Data Systems

- Medical Device Applications (Software Apps)

- Device Recalls vs. Product Enhancements

- Device Cleaning and Reprocessing

For more information about this conference visit http://www.researchandmarkets.com/research/bgsb68/fda_approval

Media Contact:

Research and Markets

Laura Wood, Senior Manager

press@researchandmarkets.com

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SOURCE Research and Markets