ResoluteAI's Foundation now offers the FDA's Classifications, Registrations and Listings, Premarket Approval, and Unique Device Identifier datasets.
The FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:
- Class I General Controls
- Class II General Controls and Special Controls
- Class III General Controls and Premarket Approval
The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.
Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as"for making incisions in the cornea." Indications for use can be found in the device's labeling, but may also be conveyed verbally during the sale of the product.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, the FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of these devices. These devices therefore require a PMA application under Section 515 of the FD&C Act in order to obtain marketing approval. Please note that some Class III preamendment devices may require a Class III 510(k).
Registrations and listings
Registration and listings provide the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the ability to prepare for and respond to public health emergencies.
Unique device identifier
Unique device identifiers (UDIs) are unique numeric or alphanumeric codes that consist of two parts—a device identifier (DI) and a production identifier (PI). UDIs are intended to increase electronic tracking abilities for devices involved in adverse events. Submission to the Global Unique Device Identification Database (GUDID) database is required for manufacturers of medical devices. The FDA is establishing a unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use.
Why search FDA datasets within ResoluteAI's research platform?
- Search all integrated datasets simultaneously
- This includes the FDA's 510(k) premarket notification
- Target research through specific search categories and tags
- Apply analytics to dataset data
- Easily share research with advanced export features
- Export searches and data visualizations
- Set up alerts directly to your inbox
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