Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
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.
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Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Health
Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesLicensing and registrations
To amend the Federal Food, Drug, and Cosmetic Act to require the registration of establishments that service devices, and for other purposes.
USA115th CongressHR-2118| House
| Updated: 4/28/2017
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.
Health Subcommittee, Energy and Commerce Committee
Health
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Administrative law and regulatory proceduresBusiness recordsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, suppliesLicensing and registrations