Agency Updates - Regulations (FDA & OSHA) (On-Demand)

Update from FDA

In this presentation, we will discuss updates at the FDA related to the Agency’s goals and the electronic Submission Template And Resource (eSTAR) Program. We will walk through how to use the FDA website to search through the Medical Device Database for cleared medical devices and other FDA regulated medical devices. Device labeling is reviewed for devices which require premarket submission. The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. We will discuss the labeling requirements per the FDA regulations and other labeling information recommended for specific devices based on device-specific guidance documents and consensus standards.

LEARNING OBJECTIVES

1. Learn about updates at the FDA and Division of Dental and ENT Devices.
2. Learn how to navigate the Medical Device Database to search for FDA Regulated Medical Devices (e.g., 510(k) Database, Registration & Listing Database).
3. Understand the application of Medical Device Labeling and the General Labeling Provisions for medical devices found Parts of Title 21 of the Code of Federal Regulations (CFR), 21 CFR Part 801 in the Instructions for Use of Dental Devices.

Steps to Complete Course:

1. Click on On-Demand Recording below and watch the video
2. Complete the Assessment (requires a passing score of 70%)
3. Complete the Evaluation 
   • Once you complete the Evaluation, you can find your CE Certificate under MY ACCOUNT > MY CERTIFICATES