You as a technical writer have written user guides, operator’s manuals, reference guides, quick start guides, other documents. When writing for a medical device, those items are considered by the FDA (Food and Drug Administration) as labeling. Yes, when you think of labeling you think of the printed matter attached to some bottle, box, or food package.
That’s true, but that big 200- to 500-page manual is labeling by definition:
21 CFR PART 801
Section 201 of the FD&C Act distinguishes between label and labeling. Certain provisions in Chapter V of the FD&C Act apply specifically to the “label” of the device, others are related to its “labeling.” These terms are related, but not interchangeable. Of the two, the term “label” is more restricted. Generally, it consists of that part of the display confined to the device itself. On the other hand, “labeling” deals with the label on the device, and descriptive and informational literature that accompanies the device.
Section 20 1 (m) defines “labeling” as:
– all labels and other written, printed, or graphic matter
- upon any article or any of its containers or wrappers, or
- “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.
So when you are searching the FDA website for information on manuals, change your search to labeling and you should find what you need.
Remember as a tech writer for the medical device industry you are held to a higher power for the information in the instructions for use (IFU), also known as the manual. There is another term to be aware of, Misbranding. Section 502 of the Food, Drug, and Cosmetic Act contains (FD&C) what the FDA considers misbranding. You are a tech writer; leave the creative writing to the marketing department. They have their own set of rules to follow. If your customer is reading the manual, they have already purchased the device. Use the links below to get more information on labeling:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081368.htm
Remember to rely on your QA (Quality Assurance) department and your RA (Regulatory Affairs) department. They are your contacts for any questions regarding the FDA guidelines.
As Sergeant Friday used to say: “All we want are the facts ma’am, just the facts.”
Beth Tripp is a technical writer for a medical device manufacturer. Beth will be posting monthly on the area of medical writing under the “MedDevDiva” title.