Join the FDA Medical Device Industry Coalition at Med2Market!

This educational forum is intended for folks with little to no experience with FDA requirements for medical device manufacturers, specification developers, and initial distributors of imported devices. It is particularly useful to entrepreneurs, very small start-up companies, new hires, students planning a career in the medical device industry or enforcement, and administrative and marketing employees in medical device firms.

The Food and Drug Administration is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

• Establishment registration,

• Medical Device Listing,

• Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),

• Investigational Device Exemption (IDE) for clinical studies

• Quality System (QS) regulation,

• Labeling requirements, and

• Medical Device Reporting (MDR

Medical Devices 101 provides a brief overview of all of the above to folks new to the medical device industry.