Medical device training under FDA

Being the regulatory body for medical devices, the FDA does not restrict itself to regulating devices that come to it. It has actively initiated a couple of programs aimed at offering medical device training. These programs, participation for which is voluntary, are called CDRH Learn and Device Advice.

CDRH Learn

The Center for Devices and Radiological Health (CDRH), under this innovative medical device training under the FDA, offers guidance and simple steps needed for medical device manufacturers to help understand the process and methods of making and marketing medical devices.

Innovative learning tool

CDRH Learn is an FDA-led training tool. It consists of modules which describe the various aspects of FDA regulations of medical device and radiation emitting products. In it, important topics for medical device manufacturers, such as premarket and postmarket are covered. CDRH Learn seeks to offer interesting, interactive and full information about medical devices that can be accessed easily.

Covers all topics relating to medical devices

The medical device training under FDA offered as part of CDRH Learn offers trainings in a number of mediums such as audio recordings, videos, and PowerPoint slides. Some of the important topics covered under CDRH Learn as part of the medical device training under FDA include:

  • Premarket Notification (510k)
  • Bioresearch Monitoring (BIMO)
  • In Vitro Diagnostics (IVD)
  • Exporting Devices
  • De Novo
  • Cross-Cutting Premarket Policy
  • Clinical Studies/Investigational Device Exemption (IDE)
  • Classification
  • Inspections – Global Harmonization
  • Medical Device Recalls
  • Medical Device Reporting (MDR)
  • Postmarket Activities
  • Quality System
  • Specialty Technical Topics
  • Radiation-Emitting Products
  • Unique Device Identification (UDI) System

Device Advice

Along with CDRH Learn, FDA training for medical devices is offered under another program called Device Advice. The FDA’s Device Advice is a comprehensive regulatory assistance program that helps those in the regulated industries understand ways of complying with the federal laws and regulations regarding medical devices.

FDA training on medical devices under Device Advice covers the following topics:

  • Recalls and alerts:
  • List of Device Recalls
  • Safety Communications
  • Recalls Database
  • Medical Device Reporting (MDR)
  • Approvals & Clearances:
  • Recently-Approved Devices
  • 510(k) Clearances
  • PMA Approvals

http://www.compliance4all.com/

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