FDA adds 1.6M hours to estimate of device labeling burden
The FDA has estimated the annual time burden of labeling regulations on the medical device industry has increased by 1.6 million hours.
In its latest submission to the Office of Management and Budget, the FDA lists tasks it thinks collectively take medical device manufacturers more than 12 million hours a year.
The increase partly stems from changes in the number of records companies need to keep and disclosures they need to make.
Medical device labeling regulations place an array of responsibilities on manufacturers. Companies are expected to ship devices with labels that include their name and location, directions for use and other details. Barring manufacturers granted exemptions, those requirements apply to all businesses. Other regulations are more specific. For example, hearing aid manufacturers must provide an instructional brochure featuring detailed information on the use and maintenance of their products.
To fulfill its duty to oversee the performance of federal agencies, the OMB asks the FDA to estimate how much time these tasks take the industry. The FDA initiated the latest calculation in February with a request for comment from the companies affected by its medical device labeling regulations. Only one person responded to the request, and that single reply was dismissed by the FDA as being off-topic.
As such, the FDA has estimated the time burden of medical device labeling regulations based on its own information and understanding. The time reached by the agency is 1.6 million hours longer than when it last submitted an estimate to the OMB. The FDA attributed the increase to its use of updated data, which features different numbers of recordkeepers, respondents, records and disclosures than the information that supported its previous estimates.
The single biggest item in the FDA’s estimates relates to retail exemption for prescription devices. This piece of legislation exempts devices from labeling requirements in certain circumstances. The FDA calculates the legislation affects 30,000 respondents who on average make 667 disclosures a year that take 15 minutes each. Those figures result in a total estimated time burden of more than 5 million hours.
The FDA is accepting feedback on the estimates until October 4.