Regulatory Terms Starting With S

Serious Adverse Event (SAE)

An adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is a congenital anomaly.

Signal Detection

The process of identifying new or changing safety information from pharmacovigilance data that may require further investigation.

Signal Management (Signal Management)

The set of activities performed to detect, validate, confirm, analyze, prioritize, assess, and manage safety signals for a medicinal product.

Special 510(k) (Special 510(k))

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

Stability Testing (Stability)

Testing to determine how a drug product's quality changes over time under the influence of environmental factors.

Substantial Equivalence (SE)

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

Supplier Qualification (Supplier Qualification)

The formal process of evaluating and approving suppliers of materials, components, and services used in GMP-regulated manufacturing.

Suspected Unexpected Serious Adverse Reaction (SUSAR)

A serious adverse event suspected to be related to the investigational product that is not expected based on the current Investigator's Brochure.

Swissmedic (Swissmedic)

Switzerland's regulatory authority for therapeutic products including medicines and medical devices.