Summary
On July 16, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.
If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by June 28, 2024, to be considered for the discussion. Questions will be not be taken during the live webinar.
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
Date: July 16, 2024
Time: 1:00PM ~ 2:00PM ET (한국시간 2024년 07월 17일, 새벽 2시~4시)
Webinar - In Vitro Diagnostic Product (IVD): Classification - 07/16/2024 | FDA
Overview of IVD Device Classification
FDA will host a webinar for industry and other interested stakeholders to discuss how in vitro diagnostic products (IVDs) are classified by the FDA
www.fda.gov
