FDA Medical Device Labeling

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What is a medical device, and how is it regulated?

The FDA defines a medical device as any product used to diagnose, treat, cure, or prevent diseases or health conditions or alter the body’s structure or function. Medical devices intended for home or professional use require clear instructions, guidance, and warnings for patients and users to ensure safety and effectiveness. Any device misuse can lead to device failure, injury, or even death. Proper labeling is crucial to prevent adverse outcomes, comply with FDA regulations, and avoid costly legal issues.

As defined by the Food Drug and Cosmetic Act (FDCA), medical device labeling extends beyond the printed label on the device and will cover all the device’s accompanying brochures, manuals (IFU), marketing materials, and website content. The FDA is strict about labeling claims on medical devices. A device is considered misbranded if it makes false or misleading claims about another device, drug, food, or cosmetic.

The information permitted on a medical device label is determined by the device class regulations, including FDA class I, II, or III, approved via 510(k), De Novo, or Pre-Market Approval (PMA). Claims that surpass the clearance, approval, or applicable FDA regulation will cause the medical device to leap into an unapproved category and, therefore, be subject to FDA enforcement.

What are general FDA device labeling requirements?

The general labeling requirements for medical devices, regardless of FDA classification, are listed below:

1. Name and place of business of the manufacturer, assembler, or distributor
2. Intended use for the medical device
3. Clear and adequate direction for safe use

Adequate directions for use refer to instructions that enable an average person to use a device safely and correctly. These directions should include:

● Statements of purposes and conditions for use

● Quantity of dose for each use

● Frequency of use

● Duration of application

● Time of administration

● Route or method of application

● Preparations necessary for use

According to the FDA, a word, statement, or other required information on the device label may lack the necessary prominence and conspicuousness for several reasons:

1) It does not appear on the part or panel displayed under customary purchase conditions.
2) It fails to appear on multiple panels when the package has sufficient space.
3) The labeling does not extend over the available package space.
4) Insufficient label space due to non-required labeling.
5) Issues like small or styled type, low contrast between labeling and background, designs
that obscure labeling, or overcrowded labeling that renders it unreadable.

The FDA mandates that medical device manufacturers use Unique Device Identification (UDI) on the device labels. The UDI enables the tracking of individual devices, and the labels must include printed and machine-readable UDI elements. Furthermore, the FDA requires device manufacturers or labelers to submit device information to the Global Unique Device Identification Database (GUDID).

How can we assist?

Labeling issues often cause delays in FDA approval and import detentions. FDA Listing Inc. has a team of device labeling experts who review labels against U.S. federal regulatory databases and FDA guidelines. We will examine your device label by cross-checking it against pertinent federal regulations to provide a comprehensive, FDA-compliant labeling review, including suggestions, UDI, and claim modifications.

Lastly, we examine your label from the individual regulatory and US customer perspectives. We provide recommendations for proper wordings based on standard American English and design implications and interpretations in the eyes of an average American customer, ensuring your product resonates in the US market.

A free initial labeling assessment is available. Please call or email us if you need assistance.

Service Details & Fees

995 USD

6-8 Days

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Frequently Asked Questions (FAQ)

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

U.S. FDA requires ﬁlling of Prior Notice before food shipments enter the United States. This will include Prior Notice for food samples for trade shows or consumption. After ﬁlling the Prior Notice, you will be assigned with a conﬁrmation number that will be used by your U.S. customs broker for the shipment release. A Prior Notice can also be ﬁled by your own compnay or international transit ﬁrms as well as shipment companies (DHL, FedEx, TNT, etc).

Do I need to keep the FDA Food Facility registration number in all communications and invoice?

Frequently Asked Questions (FAQ)

Service Details & Fees

Device Label Review

995 USD

Time Required

6-8 Days

Current Label Assessment

60 Days Unlimited Revisions

Discount on Multiple Labels

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U.S. FDA Registration

& Labeling Compliance Assistance