Device Terms (21)

A 510(k) premarket notification is the FDA submission that clears a medical device for US marketing by proving substantial equivalence to a legally marketed predicate device, not by proving safety and effectiveness from scratch.

Abbreviated 510(k) is a premarket notification format in which conformance to an FDA-recognized consensus standard, special control, or guidance document substitutes for the device-by-device test summaries a Traditional 510(k) requires.

Biocompatibility is the property of a finished medical device to contact tissue, blood, or bone without provoking an unacceptable adverse biological response, evaluated for a defined contact category and duration rather than material by material.

Class I is FDA's lowest-risk medical device class, covering devices for which general controls alone provide reasonable assurance of safety and effectiveness, without the special controls or premarket approval higher classes require.

Class II medical devices are the FDA device class subject to special controls, the additional device-type-specific requirements necessary to reasonably assure safety and effectiveness for a generic device type, beyond the general controls every device must meet.

Class III medical devices are the FDA's highest-risk device class, covering devices that are life-supporting, life-sustaining, or present a potential unreasonable risk of illness or injury, and require premarket approval rather than 510(k) clearance.

A combination product is a medical product composed of two or more regulated constituent parts - drug, device, or biological - that FDA regulates through one lead center, assigned by the constituent part providing the product's primary mode of action.

De Novo Classification Request is an FDA premarket submission that asks the agency to classify a novel device into class I or class II when no legally marketed device exists to support a 510(k) substantial equivalence review.

Design controls are the FDA-mandated design and development requirements for medical devices, governing how a device is planned, specified, verified, validated, and transferred to production, unlike production controls that govern manufacture of an already-approved design.

eSTAR is FDA's interactive PDF submission template, mandatory for 510(k) and De Novo submissions, that the CDRH Portal rejects until every applicable field and attachment is complete. eSTAR use stays voluntary for PMA, IDE, 513(g), and Q-Submissions.

Human Factors Engineering is the device design discipline that shapes the user interface so use errors capable of causing harm are eliminated or reduced, then proves it by testing critical tasks with representative users under simulated use.

IEC 62304 is the international standard defining the life cycle processes for medical device software, covering development and maintenance of software that is itself a device or embedded in one, but stopping short of final device validation and release.

Investigational Device Exemption is FDA authorization to ship and use an uncleared or unapproved device in a clinical investigation, exempting it from premarket approval and performance-standard requirements while safety and effectiveness data is collected.

ISO 14971 is the international consensus standard for applying risk management to medical devices, covering the identification, evaluation, and control of risk to patients and users across the product lifecycle rather than at a single design stage.

IVDs are reagents, instruments, and systems intended for use in diagnosing disease or other conditions, including determining a state of health. They are regulated as medical devices but act on specimens taken from the body, not the patient.

MDR (Medical Device Reporting) is the FDA post-market surveillance regime requiring manufacturers, importers, and device user facilities to report device-related deaths, serious injuries, and specified malfunctions to FDA on fixed deadlines.

PMA is the FDA's most stringent device marketing application, the pathway by which a Class III device wins approval on its own clinical and nonclinical evidence rather than by demonstrating equivalence to a marketed predicate.

Q-Submission is FDA's umbrella mechanism for a device sponsor to request feedback or a meeting rather than a marketing decision, covering Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings.

Quality System Regulation (QSR) was FDA's device current good manufacturing practice framework at 21 CFR Part 820, governing design and manufacture of finished devices until the Quality Management System Regulation superseded it on February 2, 2026.

Refuse to Accept is FDA's administrative decision that a device premarket submission is too incomplete to enter substantive review, a completeness gate applied before any scientific assessment of the device begins.

UDI is the unique numeric or alphanumeric code FDA requires on medical device labels to identify a device through its distribution and use, built from a fixed device identifier plus a conditional production identifier.