Classify Your Medical Device | FDA - U.S. Food and Drug ...
The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as...
Product Code Classification Database | FDA - U.S. Food and ...
This database contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is...
Overview of Medical Device Classification and Reclassification
The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of...
21 CFR Part 860 -- Medical Device Classification Procedures
Such a device will be classified by regulation into either class I (general controls), class II (special controls) or class III (premarket approval), depending upon the level of regulatory control required to provide reasonable assurance of the safety and effectiveness of the device (§ 860.3 (c)).
The 3 FDA medical device classes: differences and examples ...
Sep 17, 2024 · Any medical device approved by the FDA Center for Devices and Radiological Health is classified into one of three classes: either Class I, II or III, depending on its risk, invasiveness and potential impact on patient health.
Product Classification - Food and Drug Administration
Product Classification. This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory...
Understanding FDA Medical Device Classes & Their Distinctions
Jun 10, 2024 · We will delve into the nuances of medical device classification, exploring the key differences between the FDA medical device classes (Class I, II, and III) and how this classification impacts the regulatory controls and pathways to market.