FDA's CDRH Adds New Online Tools to Help Industry Learn the Ropes
Posted 17 September 2015 | By
The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released seven new modules of online information this week designed to help industry understand the various parts of medical device laws, regulations and policies.
The multimedia catalog of online educational modules, known as CDRH Learn, has now grown to over 80 educational modules, which include presentations, printable slides and transcripts. FDA began releasing the modules in 2012.
All of the latest modules are related to information on registration and listing, clinical studies/investigational device exemption, pre-submissions and standards.
One specifically includes various instructions on how to register establishments inside and outside the US. The other six include information on:
CDRH Learn Module Title
Key Learning Objective(s)
Standards Program Overview
- understand the different types of standards
- learn how CDRH uses standards during product reviews
- learn about the FDA-Recognized Standards Database
- learn how FDA interprets a standard
Standards Recognition Process
- understand how CDRH recognizes standards
- identify different types of recognition
- find recognized standards
- describe the process to request recognition of a standard
Requests for Feedback: The Pre-Submission Program and Meetings with CDRH Staff
- understand how to obtain feedback from CDRH on regulatory issues
- describe the different types of requests for feedback and when they should be used
Early Feasibility Study (EFS) Program (two modules)
(1) EFS Overview(2) EFS Process
- understand the overall concepts of the Early Feasibility Study Program
- understand the process involved with the review of Early Feasibility Studies
Presentations in the new modules are given by Scott Colburn, the director of Standards Management staff at CDRH, and Kimberly Piermatteo, a consumer safety officer in CDRH.
In addition to the modules under CDRH Learn, FDA also offers the National Medical Device Curriculum, which is a series of fictional case studies designed to help academic institutions and science and technology innovators understand FDA’s medical device regulatory processes. FDA also hosts webinars and conference calls to educate stakeholders on guidance documents and other topics related to the regulation of devices and radiation-emitting products.