To amend the Federal Food, Drug, and Cosmetic Act to require the registration of establishments that service devices, and for other purposes.

United States115th CongressHR-2118House of Representatives
Updated: Apr 28, 2017

Summary

Medical Device Servicing Safety and Accountability Act This bill amends the Federal Food, Drug, and Cosmetic Act to require establishments servicing medical devices to register with the Food and Drug Administration (FDA). Such establishments must maintain records and make reports as the FDA requires to ensure the safety and effectiveness of serviced devices. The bill exempts certain medical facilities, including physician's offices, that service medical devices in accordance with state and local laws.

Bill texts

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Introduced (House)View official text

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Timeline

  1. Referred to the House Committee on Energy and Commerce.

    House of Representatives

  2. Introduced in House

  3. Referred to the Subcommittee on Health.

    House of Representatives

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