FDA Medical Device Label Review
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 we can help you
Labeling issues often cause delays in FDA approval and import detentions. FDA Agent Pro 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.
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.
Medical Device Label Review Process Cost: $894
Step 1
Complete the initial form below, and tell us about your company
Step 2
We will issue you a short and simple questionnaire to collect additional company and medical device label details
Step 3
Current Label Assessment: Device Label Main Panel, Intended Use, Direction & Warnings Review
Step 4
Formatting & Symbols and UDI# Review
Step 5
Manufacturing Name & Contact Final Review and Analysis