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21 CFR Part 801 - FDA Labeling Requirements for Medical Devices

October 19, 20220

Medical device labeling is one of the core components of placing any medical device on the market. In this regard, 21 CFR Part 801 thoroughly covers the general FDA medical device labeling guidelines and the use of symbols. It is important to mention that the labeling guidelines in 21 CFR Part 801 requirements are not just limited to a sticker or an engraving present on the medical device. Instead, this guideline covers various forms of labeling that can be associated with a medical device i.e.

  • The instructions, and
  • The box in which the medical device is packed

The US FDA and 21 CFR 801

Three laws regulate medical device labeling in the US. They are

  • The Food, Drug, and Cosmetic Act
  • The Radiation Control of Health and Safety Act, and
  • The Fair Packaging and Labeling Act

These three laws are implemented as regulations, and among these, 21 CFR Part 801 regulates general device labeling. The primary concern in this scenario is that the medical device user must understand the medical device label to operate it safely, according to its intended purposes. Also, 21 CFR Part 801 regulations ensure that none of the medical device labelings should come as false or misleading.

Also, medical device manufacturers need to understand how the term ‘label’ is defined in FFDCA section 201(k). According to this section, a label is

‘display of written, printed, or graphic matter upon the immediate container of any article…’

Apart from section 201(k), the section 201(m) defines labeling as

all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or

(2) accompanying such article at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

Simply put, the FDA requires medical device manufacturers to put label their devices such that they are

  • Easy to understand,
  • Display all the required information, and
  • Do not display any misleading or false information

The Sub-Parts of 21 CFR 801

21 CFR 801 has the following sub-parts

  1. Subpart A- General Labeling Provisions

These provisions include the meaning of intended uses for labeling and guidelines on directions of use. The section also contains discussions on misleading statements and statements required for the Spanish language. Manufacturers can also find a list containing relevant definitions for terms used in 21 CFR 801.

Labeling provisions also include requirements for

  • Date format
  • Labeling specific to the name and place of the manufacturer’s, packer, or distributor’s business
  1. Subpart B – Labeling Requirements for UDI

Subpart B puts forward the requirements for medical devices to have a UDI (Unique Device Identifier). Manufacturers whose devices are not required to have a UDI can voluntarily opt to have one. Other requirements in Subpart B are regarding:

  • The UDI form
  • SaMD (Software as Medical Device) labeling, and
  • Requests for exception
  1. Subpart C – Labeling Requirements for OTC Devices

Subpart C contains guidelines for OTC (Over-the-Counter) devices. Examples of these guidelines include an explanation of how the statement of identity and principal display panel will be displayed. A set of requirements is also dedicated to manufacturers to tell them how they will declare the contents’ quantity per their devices’ type.

  1. Subpart D – Exemptions Regarding Adequate Directions for Use

This section contains conditions regarding exemptions for adequate directions for use. Examples can include:

  • Prescription devices
  • In-vitro diagnostic products, and
  • Devices whose adequate directions for use are usually known, etc.
  1. Subpart E – Further Exemptions

Subpart E contains some extra exemptions issued by the FDA regarding labeling. For example, some of these requirements present guidelines for a situation where a product is processed, repacked and labeled in one place, and its packaging and shipment take place in a different location.

  1. Subpart H – Special Requirements Regarding Specific Devices

It covers the requirement for particular devices, such as

  • Eyeglasses
  • Dentures
  • Hearing aids
  • Devices having ozone and CFCs

Applying 21 CFR 801 During Device Labeling

For medical device manufacturers, it is essential to consider the labeling of their devices from the very early stages. They must consider what their labeling will say and how it will be advertised. The manufacturer must also consider the regulatory pathway they want to take for the device labeling.

It is important to know that device labeling design can vary according to the regulatory plan. For example, labeling of a medical device manufacturer obliging to the 510(k)-submission route will be limited to what’s found on their predicate device. Moreover, labeling limitations may also vary according to the route taken by the manufacturer.

Another important consideration for manufacturers willing to comply with 21 CF 801 is that any written, graphic or printed material on the packaging or accompanying device also comes under labeling regulations. Therefore, they should consider labeling early in their planning so that it can be ready whenever required.

Alysidia can help with Compliant Labeling

Compliance with 21 CFR 801 can help you as a medical device manufacturer in many ways. You can expand your customer base and reach markets far and wide. This is because Alysidia’s QMS is designed to stay relevant to all the current regulatory requirements and industry standards. By taking Alysidia’s services, regarding e-labeling you can easily keep your medical devices compliant with 21 CFR 801.


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