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# Law Extends Product Info Sharing Safe Harbor to Devices
- URL: https://www.fdaweb.com/law-extends-product-info-sharing-safe-harbor-to-devices/
- Published: 2023-01-06T12:00:00.000Z
- Updated: 2026-09-14T18:11:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153490

The recently signed omnibus legislation contains language to extend a drug company safe harbor to medical device companies on sharing health care economic information to formulary committees and other similar entities prior to receiving FDA approval or clearance.

The legislation basically codifies a 2018 FDA [guidance](https://www.skadden.com/-/media/files/publications/2023/01/trend-toward-broader-communication-continues/fn1-16616687fnl-pra-update-092821.pdf?ref=fdaweb.com) on the topic, “providing certainty to drug and device manufacturers about ways they can responsibly structure such communications,” according to an [analysis ](https://www.jdsupra.com/legalnews/trend-toward-broader-communication-4537177/?ref=fdaweb.com#ftn1)by Skadden, Arps, Slate, Meagher & Flom. “The legislation also addresses a previous anomaly in the statute that permitted drug, but not medical device, manufacturers to share health care economic information (HCEI) about approved or cleared products with payors,” it says.

The law firm says the bill also requires manufacturers to update previously communicated information if such information “becomes materially outdated” as a result of unspecified “significant changes” or due to “new information regarding the product or its review status.”

Additionally, it says that by “providing statutory protection for preapproval/pre-clearance communications, Congress has recognized the importance of providing clarity regarding the manner in which manufacturers can communicate about their products, while also recognizing the importance of the exchange of particular types of information between manufacturers and certain third parties prior to product approval.”