US FDA labelling requirements for medical devices

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If you need to sell your medical devices in the US, you need to comply with labelling requirements as set by the US FDA. Let’s understand the US FDA Labelling requirements for medical devices through this article.

Name and Place of Business Labelling Requirement

In the world of regulatory compliance, precision in labelling is important. The first major US FDA Labelling requirement for you is regarding name and place of business.

  • Labels must include name and business details (street address, city, state, zip code) of manufacturer, packer, or distributor.
  • Skip street address on label if it’s already in the local telephone directory.
  • If the listed firm isn’t the manufacturer, use qualifiers like “Manufactured for…” or “Distributed by….”

Intended Use

  • For packers, distributors, or sellers with different device uses, update labelling according to the new intended use.
  • Manufacturers must update labelling if they know the device is being used for conditions or purposes other than intended.
  • Example: Dental X-ray equipment maker selling to podiatrists – update labelling accordingly.


Adequate Directions for Use

“Adequate directions for use” signifies instructions enabling non-experts to safely use a device for its intended purposes.

Key Elements:

  • Comprehensive statements about approved purposes and usage conditions.
  • Dosage information, accounting for various ages and physical conditions.
  • Guidance on frequency and duration of administration.
  • Timing considerations in relation to other factors.
  • Specification of application route or method.
  • Any necessary preparations for use.
  • Insights into exemptions from the “adequate directions for use” requirement.

False or Misleading Statements

  • Misbranding Criteria: A device is deemed misbranded if it contains inaccurate or deceptive statements regarding another device, drug, food, or cosmetic.

Lack of Required Prominence

The regulation 21 CFR 801.15 focuses on ensuring that essential information on labels is prominently and conspicuously displayed for consumers.

Visibility Under Customary Conditions

  • Required information should be on the part or panel visible under typical purchase conditions.
  • Ensures consumers can easily access and comprehend crucial details during the buying process.

Multiple Panel Consideration

  • If the package has sufficient space, the necessary information must appear on two or more panels designed for display under customary conditions of purchase.
  • Aims to prevent information from being overlooked when consumers examine different sides of the packaging.

Labeling Extension

  • Labeling should cover the designated package space to provide comprehensive information.
  • Ensures that the required details are not fragmented or incomplete.

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Space Allocation Challenges

  • Lack of sufficient label space for required information due to the placement of non-required labeling.
  • Highlights the importance of prioritizing essential information over non-essential details on the package.

Readability Factors

  • Issues such as small type size, inadequate contrast with the package background, designs obscuring labeling, or overcrowding that renders the labeling unreadable.
  • Emphasizes the need for clear and legible information to enhance consumer understanding.

Other Important tips for US FDA Labelling Requirements

  • If feasible and in accordance with FDA guidelines, consider incorporating the FDA Certification logo or  identifier. This visual cue reinforces the product’s adherence to FDA regulations.
  • Frame the FDA Certification  information in user-friendly language to ensure that even non-experts can easily understand its significance. Also Read: How to Get US FDA Certificate in India?
  • Direct consumers to your website for detailed information, offering comprehensive details beyond packaging limitations.
  • Conduct regular internal audits of labelling and packing to ensure ongoing compliance with FDA regulations.

If you need any more assistance regarding the US FDA Certification or have any other doubts regarding US FDA Labelling Requirements, you can call our experts at: 8881-069-069 and get quick assistance.

You should also know:

FDA Compliances for Exporting Food Products in USA

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