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FDA Guidance: Sponsors Of Nitinol Devices Must Address Thermomechanical Properties Of Alloy

Increasing use of nickel-titanium mix in devices demands sponsors’ close attention to testing, labeling details in submissions to FDA

Executive Summary

A new FDA final technical guidance on devices containing nitinol spells out special testing considerations and preferred labeling for the medtech products.

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FDA Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices

US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.

Clock’s Ticking: FDA Says It’s Almost Time For Health-Care Professionals To Return Essure Devices To Bayer

The US agency is reminding health-care professionals to return all Essure birth-control devices to its maker, Bayer AG, by 31 December. Although the company stopped selling Essure in the US in December 2018, professionals were allowed to continue implanting the problematic devices through the end of 2019. Meanwhile, the FDA updated its Sec. 522 postmarket surveillance study webpage for Essure.

CMS Proposes DME Rule For Diabetic CGMs, Home-Use Infusion Pumps

More external infusion pumps used in the home and continuous glucose monitors for diabetics would be reimbursed under a proposed Medicare agency rule.

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