5 Common FDA Medical Device Labeling Requirements

General medical device labelling requirements are outlined in the FDA’s 21 CFR Part 801. This documentation outlines the minimum requirements for all medical devices. Here is an abbreviated rundown on the 5 most common medical device labeling requirements.

  • Name and Place of Business (21 CFR 801.1): Each device’s label must contain the name and address of the business of the device manufacturer, packer, or distribution service. The company’s street address may be omitted only if they are listed in the local telephone directory. If the address listed on the label is not that of the manufacturer, it must clearly state who the address belongs to e.g. the distributor.
  • Intended Use 21 CFR 801.4: If the packer or distribution service or retailer indents a device to be used for purposes other than those intended by the manufacturer of the device, this party must adequately label the device according to the new use.
  • Adequate Directions 21 CFR 801.5: Each device must contain adequate direction in terms which laypersons can understand, enabling them to use the device properly and safely. This information should include:
  • purposes and conditions for use of the device
  • dosage for each use, age group and physical condition
  • frequency of use
  • duration of use
  • method of application
  • preparation needed prior to use
  • any exemptions form directions

Medical Labeling


  • False or Misleading Statements 21 CFR 801.6: The FDA considers that a device is misbranded if it’s label contains false or misleading statements regarding another device, food, medication or cosmetic.


  • Prominence of Statements 21 CFR 801.15: Required information may be considered insufficient or inconspicuous if:
  • it is not adequately displayed on a visible part of the label
  • it fails to appear on the appropriate display panels
  • there is insufficient labeling space on the package
  • the type is too small to be easily read

Contact Innovatum today to find out how we can help you with your medical device labeling requirements. Our team of experts is dedicated to meeting the compliance challenges of highly regulated industries and we specialize in the fields of biotech, pharmaceuticals, medical devices and combination products. We understand the demands of the FDA final rule and we here to utilize our leadership role in AIM North America UDI Committee and our GS1 certified label design and print technology to help you meet FDA requirements.