US HB818 | 2019-2020 | 116th Congress
Status
Spectrum: Partisan Bill (Democrat 5-0)
Status: Introduced on January 28 2019 - 25% progression, died in committee
Action: 2019-01-29 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on January 28 2019 - 25% progression, died in committee
Action: 2019-01-29 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]
Summary
Addresses design changes and reprocessing of medical devices. Reprocessing of medical devices is the process to clean and sterilize or disinfect devices for reuse. Specifically, medical device manufacturers must notify the Food and Drug Administration (FDA) (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. A device may not be sold if the manufacturer violates these notification requirements. Rapid assessment tests intended to ensure the proper reprocessing of reusable medical devices are defined as medical devices. The FDA must publish a list of the types of rapid assessment tests for which premarket notification must include validated instructions for use and validation data.
Title
DEVICE Act of 2019 Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2019
Sponsors
Rep. Ted Lieu [D-CA] | Rep. Judy Chu [D-CA] | Rep. Elijah Cummings [D-MD] | Rep. Eleanor Norton [D-DC] |
Rep. Raul Grijalva [D-AZ] |
History
Date | Chamber | Action |
---|---|---|
2019-01-29 | House | Referred to the Subcommittee on Health. |
2019-01-28 | House | Referred to the House Committee on Energy and Commerce. |
2019-01-28 | House | Introduced in House |
Subjects
Business records
Drug safety, medical device, and laboratory regulation
Government information and archives
Health
Health technology, devices, supplies
Drug safety, medical device, and laboratory regulation
Government information and archives
Health
Health technology, devices, supplies
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/116th-congress/house-bill/818/all-info |
Text | https://www.congress.gov/116/bills/hr818/BILLS-116hr818ih.pdf |