US FDA labeling guidelines for Medical Devices

  07 April, 2021

Is your medical device compliant
with US FDA labeling requirements?

In a post Covid-19 world, the medical device and IVD industry is here to witness growth like never before. With cutting-edge technological innovations and healthcare companies striving to achieve quicker go-to-market momentum, regulatory compliance often takes a backseat putting patient safety at risk. Let us quickly take you through few crucial medical device labeling requirements enforced by the US FDA (Food & Drug Administration) to ensure optimal quality and compliance of your device.

What does ‘Medical Device Labeling entail as per the US FDA?

Section 201(k) defines 'label' as a:
‘display of written, printed, or graphic matter upon the immediate container of any article…’
The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper if any there be, or the retail package of such article, or is easily legible through the outside container of the wrapper.

Section 201(m) defines 'labeling' as:
'all labels and other written, printed, or graphic matter

  1. 1.upon any article or any of its containers or wrappers or
  2. 2.accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

Key points to ensure your Medical Device labeling is FDA compliant

  • The labeling must clearly state the name and place of business of the device manufacturer. In case the device is manufactured for or distributed by another company, label must mention “manufactured for”/ “distributed by”.
  • In case of use of symbols in medical device labeling, manufacturers must include a glossary of symbols, either in paper or electronic format. Also, the device labeling must clearly notify users where to find the glossary.
  • An investigational device exemption (IDE) allows the given device to be used in a clinical study in order to collect safety and efficacy data. Medical device labels with IDE must clearly state "CAUTION - Investigational device. Limited by Federal (or the United States) law to investigational use."
  • The US FDA’s Unique Device Identification (UDI) rule requires a device manufacturer to include a unique device identifier on the device label and package. The UDI must be placed directly on the device in case it is meant to be used more than once.
  • In case of general electronic products, a medical device label must clearly indicate the place, month, and year of manufacture.
  • ‘Patient labeling’ must inform your end users, either patients or their lay caregivers of the proper use, risks, and benefits of the medical device in properly formatted, clear, lucid, jargon-free text.

Clear and informative medical device labeling is a crucial element to ensure compliance, high quality, and safety standards of your manufactured device in the FDA regulated US market. Improper or insufficient labeling can lead to product recalls or export bans, resulting in huge financial losses and potential reputational damage for a medical device manufacturing company. Athreva’s specialized team of medical device experts can help you navigate through the complex and time-consuming regulatory compliance requirements and ensure a smooth entry in the stringently regulated US medical device market.