Are there special labeling requirements for investigational devices?

Labeling. Are there special labeling requirements for investigational devices? Yes.

What does the FDA consider labeling?

Labeling is defined as all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such an article. Depending on the circumstances, labeling may include packaging, product inserts, Web sites, and other promotional materials.

In which section of 21 CFR can you find device labeling requirements?

The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in this chapter discuss any additional requirements needed for specific categories of devices.

Does the FDA regulate labeling?

The Food and Drug Administration (FDA) is responsible for assuring that foods sold in the United States are safe, wholesome and properly labeled. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA’s jurisdiction.

What requirements does the FDA have for distributors of devices?

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

• Establishment registration,
• Medical Device Listing,
• Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
• Investigational Device Exemption (IDE) for clinical studies.

Who sets labeling requirements?

The Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all “consumer commodities” be labeled to disclose net contents, identity of commodity, and name and place of business of the product’s …