FDA Regulations and Your Business : US FDA : The Traditional 510(k)

In the last column (See Archives), we continued discussion of the “Traditional” Premarket Notification (510(k)) submission to the FDA. We discussed:

5. Indications for Use
6. General Information
7. Device Information (or “Device Description”)

In this column, we will continue discussion of the contents of the “Traditional” 510(k). Let us begin with No. 8 Proposed Labeling. The requirements for labeling medical devices are complex and depend on the type of device you intend to market. For example, the labeling requirements for in Vitro diagnostic products are found in 21 CFR Part 809.10. Sometimes, there are certain specific devices that require special labeling. For example, denture repair or refitting kits have special labeling and directions that can be found in 21 CFR Part 801.405.The purpose of this column is to highlight areas of concern in assembling a 510(k) rather than be a primer on how to label devices. For detailed requirements for labeling medical devices, please consult the following convenient summary of labeling regulations found in Title 21 of the Code of Federal Regulations, which I took from an FDA guidance document

General Device Labeling -
In Vitro Diagnostic Products -
Investigational Device Exemptions -
Good Manufacturing Practices -
General Electronic Products -

- 21 CFR Part 801
- 21 CFR Part 809
- 21 CFR Part 812
- 21 CFR Part 820
- 21 CFR Part 1010

Labels and Labeling

Your 510(k) submission must contain a section where you put copies of your labeling.

Does this mean that you only have to include a copy of your label? Let us look at the definitions of "label" and "labeling" in the Federal Food, Drug and Cosmetic Act. A "label" is defined as a "display of written, printed, or graphic matter upon the immediate container of any article..." "Labeling" is defined 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.

Labeling, therefore, includes packaging labeling, special handling or storage conditions, instructions and/or instruction manuals, service manuals, articles, pamphlets, brochures, video tapes, publications, posters, circulars, UL or F.C.C. listings, etc. It can include most advertising accompanying the product. All of this labeling should be included in the Labeling section of your 510(k) submission and referenced in your Table of contents so that the FDA reviewer can find specific labeling information quickly. It is acceptable to include draft labeling if it is not yet in final form.

It is very important to examine the labeling carefully to ensure that the indications for use, described in your labeling, are identical to those in the Indications for Use form. For example, if you are selling a bone screw with the Indications for use for surgery of the foot, the FDA reviewer would not overlook advertising that mentions that the screw also works well for hand surgery.

Avoid language that could result in questions from the FDA reviewer. Make sure that all claims for therapeutic value are substantiated. Ensure that your device, its components and accessories are fully and correctly identified in the 510(k). Include all sizes, shapes, models, etc. The more information you put in, the less likely the reviewer will ask questions that slow down the review process. Review the draft labeling carefully because you do not want to be accused of making "false representations". You also want to avoid "misleading" labeling that is ambiguous or contains half-truths or subjective opinions. Make sure that pictures and diagrams are accurately displayed and that you do not include misleading testimonials.

If a company changes its labeling after the 510(k) is cleared, such as in the example of the bone screw cited above, the product would be considered to be "Misbranded" under Section 502 of the FD&C Act since it contains false or misleading labeling. Another common way of getting into trouble with the FDA under the misbranding provisions is to claim on your label that the device is "FDA Approved" or "FDA Cleared". Even putting your "K number" or FDA registration number on your label is considered by the FDA to make your product misbranded and subject to compliance actions. If the FDA finds such representations on a chart or poster at an exhibit of your product, it would likely be considered part of your labeling and constitute misbranding.

Who is Your Customer?

Whether your customer is a physician or a home user, you need to draft labeling that is clear and easy to understand. If you are frustrated reading your computer manual, try not to fill your instruction manual with jargon, unexplained abbreviations, confusing diagrams and gibberish. This is critically important, especially if your device is sold to consumers as an "over-the-counter medical device. For a home use device, especially, it is important to test the labeling to see if someone who is unfamiliar with the product can operate it exactly according to your draft instructions. Every department in your firm should ensure acceptability of the labeling.

Since the FDA requires that the labeling be in English, the English translations are sometimes written in an awkward way, which can lead to misunderstandings on, for example, how to use or care for the product. Testing the label on people living in the area where you intend to market or using a local consultant is a useful step.

Remember that your real customer is the FDA and your real product is the 510(k) because you do not get your device on the market in the United States unless your 510(k) is cleared by the FDA (or the product is exempt). The preparation of the 510(k) is a good time for the regulatory person on your staff or a consultant to review your labeling to help ensure that this section of the 510(k) will not pose problems for the FDA reviewer. At the same time, this review will help ensure that your product is used safely and effectively.

The FDA has thought a lot about helping manufacturers to communicate better. A good source for advice in this area is:
Write it Right http://www.fda.gov/cdrh/dsma/897.pdf.

Another good FDA guidance document is, Human Factors Principles for Medical Device Labeling, http://www.fda.gov/cdrh/dsma/227.html ,which contains useful tips on creating a useful instruction manual.

These and other documents and some common sense can help you prepare medical device patient labeling to make it more "understandable to and usable by patients (or family members or other lay persons caring for patients)".

In the next column, we will continue discussion of labeling with a discussion of prescription drug labeling. In future columns we will discuss other sections of the 510(k):

09. Performance Testing
10. Clinical Data
11. Substantial Equivalence Information
12. Information on Sterilization
13. Software
14. Applicable Standards
15. 510(k) Summary or Statement

Stay safe and healthy!

Norman F. Estrin, Ph.D., RAC
January 19, 2004