MEDICAL DEVICES

Device Classification
Medical devices are categorized into three classes (Class I, II, or III) based on their level of risk to patients and the regulatory controls necessary to provide reasonable assurance of safety and effectiveness. Class I devices pose the lowest risk, while Class III devices pose the highest risk.

Premarket Notification (510(k))
Most Class I and some Class II devices require premarket notification, also known as a 510(k) submission, to demonstrate that the device is substantially equivalent to a legally marketed predicate device and does not require premarket approval (PMA).

Premarket Approval (PMA)
Class III devices, which are typically high-risk devices such as implantable devices and life-sustaining equipment, require premarket approval (PMA) from the FDA to demonstrate their safety and effectiveness through clinical data and scientific evidence.

Quality System Regulation (QSR)
Medical device manufacturers are required to adhere to the FDA’s Quality System Regulation (QSR), also known as 21 CFR Part 820. The QSR establishes requirements for the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices.

Labeling and Labeling Requirements
Medical device labeling must provide essential information to users, including instructions for use, warnings, precautions, contraindications, and any applicable warnings or precautions. Labeling must comply with FDA regulations regarding device classification and intended use.

Unique Device Identification (UDI)
The FDA requires most medical devices distributed in the U.S. to bear a unique device identifier (UDI), a series of numeric or alphanumeric characters that provide information about the device’s identity and traceability throughout its distribution and use.

Postmarket Surveillance
Manufacturers are required to monitor the performance of their devices once they are on the market and report any adverse events, malfunctions, or defects to the FDA through the Medical Device Reporting (MDR) system.

Regulatory Controls for Specific Types of Devices
Certain types of medical devices, such as diagnostic tests, radiation-emitting devices, and in vitro diagnostic devices, may be subject to additional regulatory controls and requirements tailored to their specific characteristics and risks.