Medical Device Labeling: A Key Requirement for 510k

The U.S. Food and Drug Administration strictly commands that all the medical devices must have comprehensive labels that clearly states the information regarding the device. These labels are in a text or symbolic representation, that are essential to communicate between the manufacturers, healthcare professionals and patients to clearly understand the intended use, instructions, warnings and precautions.

Label: It is a printed, written or a graphical matter that is upon the immediate container of the article. The statement or the information that is present on the immediate container must also have to appear on the outside container. It’s a tag that is physically attached to the device.

Labeling: It is defined as all the labels and other written or printed matter upon a wrappers or containers that accompany a medical device while the device is for sale. It not only includes label but also includes brochures, user manuals etc additionally.

Labeling regulations are under the title 21CFR. They are as follows:

General Device Labeling

The general medical device labeling requirements are the minimum requirements for the medical devices. It is applicable to all medical devices which are regulated under FDA 21 CFR 801. Sometimes specific information and additional requirements may be needed based upon the device classification and risk level. It includes:

  • The common name, brand name, Lot number.
  • Name, place of business manufacturer, packer or distributor. If these names are related to corporation, then the name should be related to the actual corporate name.
  • The place of business includes street, address, city, state, zip code. The zip code is applied only to the consumer commodity labels. In case of non-consumer labels, the zip code will be on labeling.
  • Intended use, Adequate directions for use, use of symbols in the labeling.
  • For the over-the-counter devices the label should additionally contain information regarding the quantity.
  • If device is not manufactured for the person which is not mentioned on the label, then it has to clearly mentioned as “Manufactured For, Distributed By”.
  • The actual place of the manufactured placed in the label if it happened other than the principal place of business.
  • The adequate directions including use or purpose and the statements for which the device can be safely performed under the practitioner supervision should be clearly mentioned. It also includes the information like Frequency, quantity, duration, route of administration, time of administration which helps even layman to use safely.
  • Misleading information such as false representation with respect to another device.

In Vitro Diagnostic Products

In vitro diagnostic products are used for the diagnosis of disease, including to determine the state of the health in order to treat, cure or prevent the disease. These products are used for the collection, examination purpose which are taken from the human body. Labeling requirements are mentioned in 21 CFR 809.

Results, limitations of the procedure, expected values, specific performance characteristics are to be mentioned in the label.

If the product is used for the research purpose, then it must be clearly mentioned as, “For the research purpose only and not for the diagnostic purpose”.

If the product is for the investigation purpose, then it has to be clearly mentioned as, “For the investigational use only and have not been established”.

Reagent: Quantity, proportion, warning, precautions according to 16 CFR part 1500, storage instructions such as temperature, humidity, light, statement of purification for use.

For the products that has to be used by mixing products before use, shall be guided regarding appropriate storage conditions. The expiration date, any alteration of the product characteristics like colour etc, instructions to meet the appropriate standards.

If the inner product labeling space is small and cannot accommodate the paragraphs, then the information can be on outer container.

Analyte specific reagent: additionally for class 1 exempt devices it has to be mentioned as analytical performance characteristics were not established. And for the class 2 and 3 devices the statement is, “Except for the component cleared test analytical performance characteristics were not established.”

Instruments: Uses, installation procedure, mode of operation, performance specifications, hazards, maintenance information.

Specimen: Precautions regarding specimen collection, preservatives to maintain specimen integrity, known interference substances, storage, handling, shipping instructions to maintain the specimen, details of calibration.

Investigational Device Exemptions

The investigational device should bear quantity, contraindications, hazards, adverse effects, precautions, warnings, interfering substances.

The device that is shipped solely shall contain a label stating device “For investigational use in laboratory animals which does not involve human subjects.”

Unique Device Identification (UDI)

UDI is applicable to most of the devices, and it varies based on the classification of the device. FDA mandates that devices including implantable devices, reused devices, device that is intended for clinical use must have UDI.

This means that the identifier identifies a device through its distribution. The device identifier identifies the specific model, labeler of the device, version number.

It should ensure the compliance according to ISO/IEC 15459-2, ISO/IEC 15459-4, ISO/IEC 15459-6.

If the device is sterile, the required statement to be submitted.

The production identifier identifies the lot number, serial number, expiration date, manufactured date of the specific device.

The label should contain the name of the labeler, telephone number and email address designated under 830.320(a), name of the issuing agency.

For Natural rubber latex which is in contact with the human. The statement according to 801.437(b)(1), 801.437(b)(3), and 801.437(f) has to be submitted.

If the device size is more than one size, then the size of the model with the unit of measurement has to be appeared on the label.

The FDA listing number, global medical device nomenclature, code for the device, the number of devices contained in device package.

General Electronic Products:

The label should contain the information like the statement of the product that complies with the performance standard.

The products to be imported has to inscribed on the label.

For television receivers, if the voltage goes high in case of failure, the label should contain the warning and instructions for adjusting the voltage.

For cold cathode gas exchange tubes, safety instructions, operating instructions, power supply requirements. Tubes with x rays must indicate warning which emits x rays.

For diagnosing x ray systems, temporarily installed compatible and non-compatible components must contain warning statements as specified by FDA.

For Radiographic equipment, the override switch should be labelled as “For the x ray field limitation system failure”. Technical factors must be mentioned before the exposure.

For cabinet x ray systems, controls, warning sign such as hazards when x ray is energized has to be mentioned.

For light emitting products like laser, it requires class, output power, wavelength additional to the general labeling. For UV lamps the labeling should include instructions, model number.

For ultraviolet radiation emitting products, the label should contain operation controls, service control statement as “service adjustment only”, brand name, model designation, unique identification number, effective radiating area, ultrasonic frequency, caution statement regarding exposure.

Summary:

Labeling plays a major role in providing the accurate information for the users and caregivers. It has to clearly mentioned. In case of mishandle may harm the user. Good labeling practices can minimize the bad experience to the end-user. Establishing and maintaining the label is a very crucial aspect. Any of the misuse in the regulatory requirements can lead to delay in market approval. Contact me at um@i3cglobal.com for more information.

About the Author

A Usha Manasa (BPT)

Junior Consultant, I3CGlobal

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