FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates the labeling of all medical devices and the advertising of only restricted devices...

1. How the FDA Regulates the Advertising of
Medical Devices
By: Nikita Angane
FDA regulates the labeling and advertising of all pharmaceutical products; however, it regulates
the labeling of all medical devices and the advertising of only restricted devices.
Currently, only two types of class I & class II devices fall under the restricted devices category.
One is hearing aids and the other is Analyte Specific Reagents (ASRs). FDA may designate the
restricted device category for devices that are approved via the PMA route. Thus, most of the
class III devices are restricted, while no class I or class II devices are restricted except for the
hearing aids and ASRs.i
FDA, however, does have the authority to regulate the advertising of the non-restricted devices
related to its intended use. FDA issued several draft guidance documents in the past but has not
made any of them a final rule until now. The said draft guidance documents are:
1. Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and
Benefit Information for Prescription Drugs and Medical Devicesii
2. Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation
About Prescription Drugs and Medical Devices iii
3. Presenting Risk Information in Prescription Drug and Medical Device Promotioniv
The first guidance is about how to communicate the risk information about the device/drug on
media sites that have character space limitations such as twitter, which has a limit of about 280
characters.
The second guidance document applies to information published by third parties on the social
media/internet regardless of that information being presented on the company’s own internet
platforms or third-party platforms.
The third guidance document describes how the FDA evaluates the promotional pieces of
prescription drugs and medical devices for the disclosure of the risk information to ensure that
the benefits and the risks are accurate and not misleading.
The recommendations in these guidance documents apply to the promotional materials directed
to the consumers, as well as healthcare professionals. However, these draft guidance documents
have not become a final rule.

2. Page 2 of 2
i Hyman, Phelps & McNamara (2014) What Legal Authority Does FDA Have to Regulate Medical Device Promotion
on Internet Social Media Platforms? Retrieved on 07/24/2019 from http://www.fdalawblog.net/2014/09/what-
legal-authority-does-fda-have-to-regulate-medical-device-promotion-on-internet-social-media-pla/
ii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms with Character SpaceLimitations —
Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices retrieved on 07/24/2019
fromhttps://www.fda.gov/media/88551/download
iii FDA (June 2014) Guidancefor Industry Internet/Social Media Platforms:Correcting Independent Third-Party
Misinformation AboutPrescription Drugs and Medical Devices retrieved on 07/24/2019 from
https://www.fda.gov/media/88545/download
iv FDA (May 2009) Guidancefor Industry Presenting Risk Information in Prescription Drugand Medical Device
Promotion retrieved on 07/24/2019 from https://www.fda.gov/media/76269/download