Streamlining the Regulatory Path to Market for Low-Risk Med Devices | Page 4

WHAT ARE
MEDICAL DEVICES? 5
MEDICAL DEVICES
CAN INCLUDE:
INSTRUMENTS
IMPLANTS

Understanding the Classes and
Corresponding Regulatory Controls
The Class to which a device is assigned determines,
among other things, the type of premarketing submission
or application required for FDA clearance to market.
The FDA has made Class designations for approximately
1,700 device types and groups the devices into 19 medical
specialties, called panels.6 The regulatory controls for the
Classes are as follows:

MACHINES
SOFTWARE

CLASS I: GENERAL CONTROLS

MATERIALS

CLASS II: GENERAL CONTROLS
AND SPECIAL CONTROLS

CALIBRATORS
APPARATUSES
IN VITRO REAGENTS

MEDICAL DEVICES
ARE USED TO:
COPE WITH HUMAN DISEASE
CARE FOR HUMAN INJURIES
MEET ANATOMICAL NEEDS
MAINTAIN PHYSIOLOGICAL
FUNCTIONS
SUPPORT HUMAN LIFE
CONTROL HUMAN
CONTRACEPTION
DISINFECT MEDICAL DEVICES
U