By Nick Otto
The FDA is seeking industry feedback on the recordkeeping burdens medical device-makers face in maintaining labels.
According to draft guidance published in the Federal Register, the Federal Food, Drug, and Cosmetic Act contains requirements for the labeling of a medical device to avoid misbranding, and certain provisions “require device manufacturers, importers and distributors to disclose information about themselves or the devices, on the labels or labeling for the devices.”
The burden comes as regulations require device manufacturers to keep a copy of the agreement containing the specifications for the processing, labeling, or repacking of the device for two years following the shipment or delivery of the product.
A slew of recordkeeping and third-party disclosure requirements are listed that the FDA is seeking feedback on, including:
- Labeling for a device in package form must contain the name and place of business of the manufacturer, packer, or distributor.
- Labeling must contain the device’s name and intended use.
- The label for an over-the-counter device’s package must establish the identity of the device.
- Labeling for prescription devices must describe the application or use of the device and contain a cautionary statement restricting the device for sale by, or on the order of an appropriate professional.
The FDA earlier this summer eased some labeling burdens with regard to information on the Internet and social media.
Draft guidance released in June addresses how a device-maker may appropriately respond to misleading or incorrect information about a company’s products on the Internet or social media. Under this draft guidance, the FDA suggests if a third party posts incorrect or misleading information about a device, a manufacturer’s response, as long as factual and not promotional, wouldn’t need to be regulated under the FDA’s labeling requirements.
“Labeling has been interpreted expansively to mean essentially anything that describes the drug or medical device product, regardless of whether it is attached to the product,” The National Law Review notes.
Additionally, access to labeling mishaps has taken some strides, as the agency’s new openFDA initiative for easier access to data will provide a number of high-value structured datasets, including documentation like structured product labeling data.
The FDA is accepting comments on labeling burdens through Sept. 30.