Hi all

Could anyone explain or quote in order of importance the differance between
a guide a standard and regulation. I think I have the correct answer but never seen acceptable reference or explanation in any document,maybe you could guide me to valid source for this kind of information.

I’ll give it a shot. This is strictly off the cuff and just based on my experience.

Standard - a roadmap. There are many ways and means to reach the desitnation but the standard requires some specific things be done along the way. Think ISO.

Guide - a route (generally on implementation of a standard or regulation). The guide describes ways and / or means which are generally practical or ‘normal.’ You can drive from Florida to California via New York but you will spend extra time and money doing so.

Regulation - laws you have to live by on your journey. Think 21 CFR 820. Think fines or jail time. :slight_smile:

Lovely explanation yodon!


I would adjust Yodon’s definitions for “Guide” and “Standard” per ASQ (American Society of Quality) training on 510(k) and PMA submissions. During that training they put those terms in the same order that you do. A Guidance is an advisory document representing the FDA current thinking on a topic. The thinking is subject to change and so the document does not bind the FDA (
). A Standard (more correctly a “Consensus Standard”) gives acceptance criteria for a specific performance characteristic (
). When making a device submission, a company can use testing against the accepted standard rather than doing V & V testing (clinical studies for instance). This reduces testing and clarifies the results for the FDA auditor. This path is often taken for Abbreviated 510(k) applications.

Yodon’s definition of Regulation is crisp and clear.

Tom B

Why not go to;

and download the free glossary. You will find all three of these words defined there.

Alex Kennedy

Standard: you can apply voluntarily
Regulation: you must obbey it


Good discussion, Terms are very nicely defined. Just to add…

Standard : something considered by an authority or by general consent as a basis of comparison.
Regulation : A rule designed to control the conduct of those to whom it applies.
Guidance : Advice or information aimed at resolving a problem or difficulty.