What does this LOINC code represent?

This LOINC code identifies a lab observation, measurement, question, or clinical concept in a standardized format.

Is this enough to understand my test result?

No. The code identifies the test or observation, but the interpretation depends on the actual result, reference range, and clinical context.

LOINCActive

LOINC Code 60563-4: FDA package insert Summary of safety and effectiveness

Name: LOINC Code 60563-4: FDA package insert Summary of safety and effectiveness
Creator: HealthAssure Clinical Team
Published: 2026-05-21T08:59:40.316Z

60563-4 is a LOINC code used to identify FDA package insert Summary of safety and effectiveness in laboratory and clinical observation data. You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges. LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component Summary of safety and effectiveness. It is commonly used with the system or sample type ^FDA package insert.

Reviewed by HealthAssure Clinical TeamUpdated 21 May 2026

What is this code?

LOINC codes identify tests, measurements, observations, survey items, and clinical questions in a standardized way. It is associated with the component Summary of safety and effectiveness. It is commonly used with the system or sample type ^FDA package insert.

When is it used?

Used in lab systems, EHRs, and clinical data exchange.
May identify a test, observation, survey item, or clinical document request rather than a diagnosis.
Status: ACTIVE

What it does not mean

The code identifies the observation or test, not the actual result.

Key facts

FDA package insert Summary of safety and effectiveness
Summary of safety and effectiveness
DOCUMENT.REGULATORY; FDA insert; Narrative; Report; SPL; Structured Product Labelling; Summ of safety/effect

Where you may see this code

You may see this code in lab systems, lab reports, EHR exports, interoperability feeds, or other structured clinical data exchanges.

Common synonyms

FDA package insert Summary of safety and effectivenessFDA insert Summ of safety/effectSummary of safety and effectivenessDOCUMENT.REGULATORY-^FDA package insertNar

Frequently asked questions

Code details

Code60563-4

SystemLOINC

Display nameFDA package insert Summary of safety and effectiveness

DescriptionSummary of safety and effectiveness

Short nameFDA insert Summ of safety/effect

ComponentSummary of safety and effectiveness

Property-

Timing-

System (specimen)^FDA package insert

ScaleNar

ClassDOCUMENT.REGULATORY

StatusACTIVE

Flags

BillableNo

Valid clinical useNo

Source

SourceLOINC

Version2.82

Releasemain

First released2.34

Last changed2.34

Part names

Summary of safety and effectiveness-^FDA package insertNar

About this content

This page is prepared by HealthAssure's clinical team using official coding standards from LOINC. AI tools assist with drafting explanations, which are then reviewed and verified by healthcare professionals for accuracy. This content is for informational purposes and does not replace professional medical advice. Meet our team.