Premarket Notification (510k)
Premarket Notification 510(k) Overview
Video 
   Printable Slides
510(k) Format Guidance, Including Standards Form, and Extensions/Clinical Trial Form and 510(k)
Video    Printable Slides
510(k) Third Party Review
Video    Printable Slides
510(k) Electronic Submission Pilot Program – New! 5/5/14
Printable Slides   Transcript
Post Test for all 510(k) Modules
Clinical Studies/Investigational Device Exemption (IDE)
What is an Investigational Device Exemption (IDE)?
Video    Printable Slides   Transcript
Idea to IDE: A Medical Device in the Making
Video
FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations [DRAFT Guidance]
Audio Recording (MP3)   Printable Slides   Transcript
IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies
Audio Recording (MP3)   Printable Slides   Transcript
FDA Guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices
Audio Recording (MP3)   Printable Slides   Transcript
Biorearch Monitoring (BIMO)
BIMO Part 1a – Good Clinical Practice 101: An Introduction
Video    Printable Slides   Post Test
BIMO Part 1b – Introduction to the Bioresearch Monitoring Program
Video    Printable Slides   Post Test
BIMO Part 2a – The Sponsor: Responsibilities in Medical Device Clinical Trials
Video    Printable Slides   Post Test
BIMO Part 2b – The Clinical Investigator: Responsibilities in Medical Device Trials
Video    Printable Slides   Post Test
BIMO Part 2c – Computerized Systems Used in Medical Device Clinical Investigations
Video    Printable Slides   Post Test
BIMO Part 3a – Institutional Review Board: Responsibilities in Making the Significant Risk and Non-significant Risk Device Determination
Video    Printable Slides   Post Test
BIMO Part 3b – Institutional Review Board: Humanitarian Use Devices (HUDs)
Video    Printable Slides   Post Test
BIMO Part 3c – Institutional Review Board: Compassionate and Emergency Use
Video    Printable Slides   Post Test
BIMO Part 4a – Preparing for an FDA Medical Device Sponsor Inspection
Video    Printable Slides   Post Test
BIMO Part 4b – Preparing for an FDA Clinical Investigator Inspection
Video    Printable Slides   Post Test
BIMO Part 4c – Preparing for an FDA Institutional Review Board Inspection
Video    Printable Slides   Post Test
BIMO Part 5a – Strategies for Sponsors to Build Quality into Device Research
Video    Printable Slides   Post Test
BIMO Part 5b – Strategies For Clinical Investigators to Build Quality into Device Research
Video    Printable Slides   Post Test
Preparing for a Clinical Investigator Inspection
Video    Transcript
CDER Small Business Webinar on Building Quality into Clinical Trials – an FDA Perspective
Classification
“513(g)s” Including 513(g) User Fees
Video    Printable Slides
Product Codes Making the Connection
Video    Printable Slides
Medical Device Classification and Reclassification Procedures – Proposed Rule
Recorded Webinar (3/24/14)    Printable Slides   Transcript
Cross-Cutting Premarket Policy
How to Create and Submit an eCopy
Video
510(k) User Fees
Video    Printable Slides
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
Video    Printable Slides   Transcript
Pre-Submissions and Meetings with FDA Staff
Recorded Webinar (2/28/14)    Printable Slides   Transcript