Bill
Bill > HR2426
US HR2426
US HR2426To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.
summary
Introduced
05/19/2015
05/19/2015
In Committee
05/22/2015
05/22/2015
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.B. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.) Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.
AI Summary
This bill aims to reduce regulatory burdens on certain medical devices by amending the Federal Food, Drug, and Cosmetic Act. Specifically, it requires the Food and Drug Administration (FDA) to identify and exempt certain Class I devices, which are generally considered low-risk and do not require special controls to ensure safety and effectiveness, from needing to submit a pre-market report to demonstrate reasonable assurance of safety and effectiveness. Similarly, for Class II devices, which require special controls to assure safety and effectiveness, the FDA must publish a list of those that no longer need such a report, with an extended 60-day public comment period for these proposed exemptions. This process is intended to streamline the approval process for devices deemed to pose minimal risk, thereby easing regulatory requirements.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (1)
Last Action
Referred to the Subcommittee on Health. (on 05/22/2015)
Official Document
bill text
bill summary
Loading...
bill summary
Loading...
bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/house-bill/2426/all-info | 05/20/2015 |
| BillText | https://www.congress.gov/114/bills/hr2426/BILLS-114hr2426ih.pdf | 07/04/2016 |
| Bill | https://www.congress.gov/114/bills/hr2426/BILLS-114hr2426ih.pdf.pdf | 07/04/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114hr2426ih/pdf/BILLS-114hr2426ih.pdf | 05/28/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114hr2426ih/pdf/BILLS-114hr2426ih.pdf.pdf | 05/28/2015 |
Loading...