Infographic: Finding FDA Recognized Standards

Mastering the FDA Standards Database

A visual guide to finding recognized consensus standards for a streamlined medical device submission.

Why Use Recognized Standards?

Leveraging FDA-recognized standards is a cornerstone of an efficient regulatory strategy. By submitting a "Declaration of Conformity" to a recognized standard, manufacturers can demonstrate device safety and effectiveness without providing exhaustive raw test data, significantly accelerating the path to market clearance.

This approach reduces regulatory burden and can shorten review timelines.

Impact on Regulatory Efficiency

The 5-Step Process to Find Your Standard

1

Access the Database

Begin by navigating to the FDA's "Recognized Consensus Standards" online database.

2

Search Strategically

Use the search function by device name, standard designation (e.g., ISO 13485), or medical panel.

3

Filter & Refine

Narrow your results by Standard Development Organization (ISO, ASTM), recognition date, or category.

4

Interpret the Results

Analyze key columns like Standard Designation, Title, and Recognition Number to identify relevant standards.

5

View Full Details

Click into the standard to understand its full scope, recognized sections, and any FDA-specific limitations.

Common Standard Categories

The database covers a wide range of categories. The chart below shows a representative distribution of available standards across key areas, highlighting the most common types you will encounter.

A thorough search of the FDA standards database is not just a preliminary step—it's a critical component of your regulatory strategy that demonstrates due diligence and builds a strong foundation for a successful submission.