A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package Inserts

November 29, 2016By: Jeffrey K. Shapiro Download PDF

In 1976, the FDA first began comprehensive regulation of medical devices. Among the new statutory provisions, there was one requiring persons registering with FDA to list all marketed devices. Each device on the list was to be accompanied by a copy of the label and package insert (see Section 510(j)of the Federal Food, Drug, and Cosmetic Act).

Within two years, the FDA had decided that requiring a copy of the label and package insert was not going to be practical or useful. The FDA said that it might not need the information when submitted and, unless consistently updated, it might be out of date when needed. Also, there was no practical way to compile, update or access the information, much less provide routine public access.

Typically, the device listings were submitted on paper and manually transcribed into data storage on reels of magnetic tape and floppy disks. Therefore, in lieu of requiring compliance with the actual statutory requirement, the FDA required device firms to maintain a historical file of labels and labeling available upon the FDA’s request.

Fast forward almost 40 years. The Internet is now pervasive and electronic storage is robust and easily searchable. Taking advantage of the now-established technology, the FDA is proposing to give new life to the requirement in Section 510(j).