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www.fdanews.com/articles/213250-advamed-says-consumers-right-to-repair-rules-could-damage-patient-safety

AdvaMed Says Consumers’ Right to Repair Rules Could Damage Patient Safety

February 13, 2024

While consumers wanting the ability to fix products they’ve purchased came through with over 1,600 comments and strongly-worded frustrations supporting their “right to repair” their own possessions, the issue continues to rankle medical device makers looking to protect their intellectual property rights and the safety of FDA-regulated medical devices.

A Petition for Rulemaking to the FTC on the issue was submitted last November by the U.S. Public Interest Research Group Education Fund (PIRG) and California-based home repair advocacy group iFixit. The petition, posted by the FTC on Jan. 3 with one month provided for public comment, urged the FTC to create rules that protect consumers’ right to repair, on their own, the products purchased across various industries, with an underlying presumption that unfair practices prevent consumers from repairing their own possessions.

As it relates to the medical device industry, AdvaMed, begs to differ. AdvaMed believes “right to repair” was initiated to focus on cars, cellphones and household appliances, and should not drift into medical equipment regulated by the FDA.

Read the PIRG/iFixit Petition for Rulemaking here.

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