Medical Device Labeling Compliance Under 21 CFR Part 801

Labeling is defined as the “display of written, printed, or graphic matter upon the immediate container of any article.” Any medication that is intended to be distributed must be labeled as per the Parts of Title 21 of the Code of Federal Regulations (CFR).

General Labeling Provisions Under 21 CFR Part 801

The US Food and Drug Administration (FDA) Medical Device labeling requirements demand all risk classes to include mandatory information on the device labeling:

• Name of business of the manufacturer, packer, or distributor
• If the name of the person who did not manufacture the device is on the label - Use Abbreviations such as “Manufactured for___” or “Distributed by___”
• Abbreviations for “company “can be used
• Place of business - Business unit Address, City, State, Zip code
• Adequate directions for the use
• Frequency, duration, time, route of administration, and Preparation for use.
• Accepted format for date (YYYY-MM-DD) Eg; 2014-01-04 for January 4, 2014
• Every medical device label and package should bear FDA Unique Device Identifier (UDI) labeling requirements

Language Requirements Using Symbols

The required label statements must be in the English language. In territories where the predominant language is not English, the language may be substituted, such as Spanish in Puerto Rico.

An FDA-recognised or standards development organization (SDO) established symbol can be used without an explanatory text. Otherwise, the symbols must be accompanied by English explanatory text. For regions where  English is not predominant, the respective regional language can be used.

Labeling Requirements for Over-the-Counter (OTC) Devices

The Principal Display Panel must include all the mandatory label information without causing any crowding, conspicuousness, and obscuring design. The labeling must include the following:

• Statement of Identity, including the common name of the device and accurate principal intended action(s) of the device
• The declaration of accurate net quantity of contents
• Reasonable variations caused by loss or gain of moisture during distribution should not be large and should be stated
• The declaration is in letters and numerals such that it fits well in the display panel. It should be uniform for all packages

The OTC devices containing or manufactured with chlorofluorocarbons (CFC), halons, carbon, ozone tetrachloride, methyl chloride, or any other Environmental Protection Agency (EPA) class I substances shall carry one of the warnings either on the immediate container, outer packaging, or labeling component. The use of CFCs in devices as propellants in self-pressurized containers is generally prohibited. The below warning statement is a must

EPA warning statement- “Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and environment by destroying ozone in the upper atmosphere.”

In addition to the EPA warning statement, the Federal government's Clean Air Act for all products requires the underneath statement for devices containing or manufactured with CFCs.

“Consult with your physician, health professional, or supplier if you have any questions about the use of this product.”

Device-Specific Labeling Requirements

Repairing or Refitting dentures

Wearing improperly repaired or refitted dentures continuously causes increased bone resorption and other irreparable damage to the oral cavity. The FDA medical device labeling guidelines regard labeling claims exaggerating the usefulness or the safety or failing to disclose all facts of the material as false and misleading. Such products are considered unsafe and misbranded unless the labeling:

• Limits directions for the use of denture repair kits for emergency repairing, denture recliners, pads, and cushions to temporary refitting
• Contains the word that precedes “emergency” for denture repair kits and the word “temporary” preceding recliners, pads, and cushions in the IFU
• Includes a conspicuous warning statement to the effect:

1. For denture repair kits: “Warning - For emergency repairs only. Long-term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This kit is for emergency uses only. See Dentist without delay.”
2. For denture recliners, pads, and cushions: “Warning - For temporary use only. Long-term use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For use only until a Dentist can be seen.”

• Adequate directions for use must have full information for the layman to understand the limitations of usefulness
• A warning statement should be included if the denture relining or repairing material forms a permanent bond with the denture

“This recliner becomes fixed to the denture, and a completely new denture may be required because of its use.”

Labeling for Prescription Hearing Aid

The outer and inner packaging labels should include a warning for prior medical evaluation from a doctor, preferably an Ear, Nose, and Throat (ENT) in cases of users younger than 18 years, and the conditions when to consult a doctor. The labeling must communicate to the user what to expect from the use of a hearing aid, information on the function of all controls intended for user adjustment, description of any accessory that accompanies the prescription hearing aid, maintenance, and care, expected battery life, whether it is rechargeable or single-use, type of battery needed and method of changing it, any side effects and when the patient should meet the ENT. The labeling must include information on:

• Serial number of the device
• Statement of build condition on the outer package whether the hearing aid is used or rebuilt
• If the prescription hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact
• Battery information on the outer package –Type and number of batteries (if included in pack)
• Indication of control platform – indicate if the mobile device or other non-included control platform is required, the type of platform, and how the platform connects to the device.
• If the battery is removable, a “+” symbol indicates a positive terminal for battery insertion unless physical design prevents inserting the battery in the reversed position
• Pre-requisites for dispensing Hearing Aid and determining the right prospect
• List of possible adverse events, device reporting manufacturer, and the market complaint process

Warnings

• Special warning for dispensing Hearing aids with an output of over 132 dB SPL
• Not using the device for hearing protection
• To reduce the volume/remove the piece if the sound output is painful or uncomfortable
• To seek medical help in case the device is stuck in the ear
• Information on ear wax build-up drops, immersion in water, or exposure to heat
• Information on how and where to obtain repair service or replacements, including at least one specific address where the user can go or send the prescription hearing aid.
• Technical specifications must be included in the user instructional brochure. Software labeling about compatibility, minimum operating requirements, any fees, or payments

Labeling for Menstrual Tampon

Toxic shock syndrome (TSS), a rare but sometimes fatal, is associated with the use of menstrual tampons. The label must bear below information on warning signs of TSS, e.g., sudden fever (usually 102° or more) and vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like a sunburn, what to do if these or other signs of TSS appear, including the need to remove the tampon at once and seek medical attention immediately. The label must include the following:

• Absorbency terms
• A description of how consumers can use the range of absorbency, and its absorbency term, to make comparisons

This helps in tampon selection with the minimum absorbency needed to control menstrual flow reducing the risk of contracting TSS.

Labeling Requirements for Condoms Containing LATEX

The condoms are made with spermicidal lubricant formed from latex films. The material integrity of latex condoms degrades over time and hence must bear an expiration date that is supported by testing, displayed prominently and legibly on primary packaging. The condoms qualifying the physical and mechanical integrity tests can bear an expiration date of up to 5 years from the date of product packaging. In the case of a spermicide-containing latex condom, if the expiration date based on spermicidal stability testing and latex integrity testing are different, the product shall bear only the earlier expiration date.

Labeling Requirements for Condoms Containing Natural Rubber

Applicable to products containing natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation. Natural rubber may cause severe anaphylactic reactions, and the labeling is intended to minimize the risk to individuals sensitive to natural latex proteins. The inclusion of the term “hypoallergenic” is prohibited as it can be misleading. The labeling statement must be in bold print, prominently, and legibly displayed.

“This Product Contains Dry Natural Rubber.”

Labeling isn’t just about a sticker or engraving on a device. It covers important details associated with the medical device. FDA medical device labeling guidelines consider the label misbranded when any of these above instructions are not followed accurately. Incorrect labeling is one of the top five (05) reasons globally for device recalls.  While designing a medical device label, it is important to consider the Regulatory pathway we chose to pursue along with the exemptions that apply. It is imperative to address the labeling requirements early on in planning so one can be prepared when it is needed.

Complying with 21 CFR part 801 labeling guidelines is critical for organizations. How aligned are you? To know more about 21 CFR part 801, contact our Regulatory experts at Freyr.