Two Day Seminar: FDA Approval Process for Medical Devices (London, United Kingdom - April 27-28, 2017) - Research and Markets

DUBLIN--()--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.

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 prior to the initial submission of novel devices to help ensure a successful submission process. Finally, some hot topics will be presented. Depending on the interest of the participants, these may include new FDA requirements and policies involving Unique Device Identifier, regulation of device software, and how to distinguish device enhancements from being considered a recall, and device reprocessing guidance.

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/8tlswj/fda_approval

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices