Device Terms (24)

A premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed predicate device.

A 510(k) pathway that relies on FDA guidance documents, recognized consensus standards, or special controls to establish substantial equivalence.

The ability of a medical device material to perform its intended function without causing adverse biological response in contact with tissue, blood, or other body fluids.

Low-risk medical devices subject to general controls and, in most cases, exempt from 510(k) premarket notification.

Moderate-risk medical devices subject to general controls plus special controls, typically requiring 510(k) premarket notification.

Highest-risk medical devices requiring Premarket Approval (PMA) based on clinical evidence of safety and effectiveness.

A therapeutic product combining two or more regulated components (drug, device, biologic) with a primary mode of action determining the lead FDA center.

A pathway for novel low-to-moderate risk medical devices that lack a predicate but do not require PMA-level review.

Systematic practices applied during product design and development to ensure devices meet user needs and intended uses.

FDA's interactive PDF template required for all 510(k) submissions and extended to De Novo classification requests.

The application of usability knowledge to medical device design to minimize use-related hazards and support safe, effective operation.

The international standard defining software lifecycle processes for medical device software.

A medical device used to perform tests on samples taken from the human body to detect diseases, conditions, or infections.

FDA authorization allowing an unapproved medical device to be used in a clinical investigation to collect safety and effectiveness data.

The international standard for application of risk management to medical devices across the full product lifecycle.

FDA mandatory reporting requirements for manufacturers and user facilities when medical devices may have caused or contributed to death or serious injury.

The FDA process for approving Class III high-risk medical devices based on clinical evidence of safety and effectiveness.

FDA's formal mechanism for device sponsors to obtain feedback on development plans, submission content, or regulatory strategy before filing.

FDA regulations governing the methods and facilities used in the manufacture of medical devices.

FDA's decision not to accept a 510(k) submission for substantive review due to administrative or completeness deficiencies.

An expedited 510(k) pathway for device modifications made by the original manufacturer of a previously cleared device.

The FDA determination that a new medical device is as safe and effective as a legally marketed predicate device, allowing 510(k) clearance.

The standard 510(k) premarket notification pathway for Class II devices demonstrating substantial equivalence to a predicate.

A system for identifying medical devices through their distribution and use using a unique numeric or alphanumeric code.