FDA Regulatory Pathways for Medical Devices

Flashcards covering key vocabulary related to FDA regulatory pathways for medical devices.

FDA (Food and Drug Administration)

The US agency responsible for regulating food, drugs, medical devices, and other health-related products.

Medical Device

An instrument, apparatus, machine, implant, or similar article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease.

PMA (Pre-market Approval)

A regulatory pathway for high-risk devices ensuring that sufficient evidence supports the device's safety and effectiveness.

510(k) Submission

A pre-market notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

HDE (Humanitarian Device Exemption)

A regulatory provision that allows manufacturers to develop devices intended for diseases affecting fewer than 4,000 individuals annually without meeting typical efficacy requirements.

Class I Devices

Medical devices classified as low risk; generally, they have the least regulatory requirements.

Class II Devices

Moderate-risk medical devices that require pre-market notifications, and may be marketed once the FDA clears their 510(k) submission.

Class III Devices

High-risk medical devices that must undergo rigorous safety and effectiveness testing through a PMA before marketing.

Substantial Equivalence

A standard by which a device is compared to a predicate device to demonstrate its safety and effectiveness.

Pre-market Notification (PMN)

The process by which manufacturers notify the FDA of their intent to market a device.

Quality System (QS) Regulation

Regulations ensuring that manufacturers consistently produce devices that meet quality standards.

Regulatory Pathway

The specific route a medical device manufacturer must follow to obtain approval from the FDA to market their product.

Post-market Surveillance

Activities undertaken to monitor the safety and effectiveness of a medical device after it has been approved and is available in the market.

Medical Device Reporting (MDR)

A system for FDA to receive reports of device-related injuries, malfunctions, and deaths.

De Novo Classification

A process for classifying new devices that do not have a predicate and are automatically assigned to Class III unless they can be reclassified to Class I or II.

Risk-based Classification System

The system established by the FD&C Act to categorize medical devices into classes based on the level of risk they pose to patients.