U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Devices News and Events
  4. Webinar - In Vitro Diagnostic Product (IVD): Classification - 07/16/2024
  1. Medical Devices News and Events

Webcast | Virtual

Event Title
Webinar - In Vitro Diagnostic Product (IVD): Classification
July 16, 2024

Date:
July 16, 2024
Time:
1:00 PM - 2:00 PM ET

Summary

On July 16, 2024, the U.S. Food and Drug Administration (FDA) held a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.

Background

In vitro diagnostic products (IVDs) are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. [21 CFR 809.3]

IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are generally also subject to categorization under the Clinical Laboratory Improvement Amendments (CLIA '88) of 1988.

The FDA classifies medical devices, including IVDs, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process.

Webinar Materials

The presentation, printable slides, and transcript are available at CDRH Learn under "In Vitro Diagnostics."

If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

 
Back to Top