Bill
Bill > HR2424
US HR2424
US HR2424To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.
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 training and oversight in least burdensome appropriate means concept. This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process. When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.
AI Summary
This bill mandates that Food and Drug Administration (FDA) employees who review premarket submissions for medical devices, including supervisors, must receive training on the "least burdensome appropriate means" concept, which means the FDA should seek the simplest way to confirm a device is safe and effective without being overly demanding on applicants. The bill also requires the FDA's ombudsman, who is responsible for overseeing the review process for devices, to audit this training and interview industry representatives about their experiences with the device review process. Furthermore, when the FDA requests more information from an applicant seeking premarket approval for a medical device, it must consider the least burdensome appropriate means necessary for the applicant to prove the device's safety and effectiveness, defining "necessary" as the minimum information needed to assure safety and effectiveness, without changing the overall standards for device approval.
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
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/house-bill/2424/all-info | 05/20/2015 |
| BillText | https://www.congress.gov/114/bills/hr2424/BILLS-114hr2424ih.pdf | 07/07/2016 |
| Bill | https://www.congress.gov/114/bills/hr2424/BILLS-114hr2424ih.pdf.pdf | 07/07/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114hr2424ih/pdf/BILLS-114hr2424ih.pdf | 05/29/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114hr2424ih/pdf/BILLS-114hr2424ih.pdf.pdf | 05/29/2015 |
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