Marketing, Advertising and Claims for Devices Under the Amended FDA Intended Use Regulation and Under MDR / IVDR

Monday, September 12, 2022

2:00 PM – 3:00 PM MST

Location/Room: W101 A-B

Session Room Sponsored By

Learning Level Applied

Session Leader/Speaker(s)

This session will discuss the challenges of the new FDA intended use regulation and the new EU MDR/IVDR for Marketing, Advertising and Claims.

The first part of the session will focus on the FDA intended use regulation and will discuss the pervasiveness of the regulation in the entire product lifecycle, including new areas of FDA's interest and mindset with respect to off-label promotion. The session will highlight examples FDA provided during rule making about what activities FDA would consider as evidence of intended use and when the Agency would exercise enforcement discretion. We will also discuss the impact of the new regulation on safe harbored communications regarding off-label use; operational impact of the new regulation, provide practical tools and tips for interpreting the regulation and the future developments at the FDA to look out for.

The second part of the session will discuss new rules under MDR and IVDR and their consequences relevant to marketing, advertising and claims, which introduce new links between marketing and advertising claims and regulatory documentation such as the IFU and clinical/performance evaluation. As a result, manufacturers and others making claims for devices need to observe additional requirements to ensure that the claims made are always consistent throughout all internal and external claims and regulatory documentation. The presentation will also address differences with the MDD and the IVDD, restrictions and possibilities of advertising of pipeline devices, comparative claims, other relevant EU regulations, links with EU product liability regulation and QMS aspects of claims management.

The final part of the session will discuss the nuances in the marketing, advertising and claims for RUO products.

Better understand FDA’s 'Intended Use' Regulation, its pervasiveness in the product lifecycle, and how it can shape enforcement actions.
Understand new MDR and IVDR requirements for claims and how to ensure that claims for a device remain compliant over time under MDR and IVDR.
Understand the nuances for marketing, advertising and claims for RUO products for the US and EU.