Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products. [HB-2479]
To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products. This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Department of Health and Human Services (HHS) to review each regulation and guidance that applies to the dissemination by means of the Internet of information about medical products and to propose revisions to such regulations and guidance that: facilitate meaningful
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Sponsored by: Rep. Billy Long
Referred To The Subcommittee On Health. on 05/22/2015
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Delivering Antimicrobial Transparency in Animals Act of 2015 [HB-2459]
Delivering Antimicrobial Transparency in Animals Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to revise reporting requirements for new animal drugs containing an antimicrobial. Certain live poultry dealers, swine contractors, and feed lot operators who purchase, contract, or manufacture animal feed containing a new antimicrobial animal drug must annually report to the Food and Drug Administration, by food-producing animal, the amount of drug per kilogram of feed, and the quantity of feed sold or distributed. Additional information
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Sponsored by: Rep. Ted Lieu
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine. [HB-2455]
To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.) The FDA must issue and periodically update guidance that addresses the development and use of
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Sponsored by: Rep. Joseph Pitts
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information. [HB-2452]
To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information. This bill amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for health care economic information that is provided to entities selecting drugs for coverage or reimbursement, such as formularies. The information must include a conspicuous and prominent statement describing the differences between the information and the labeling approved for the drug. "Health care economic information" is an analysis
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Sponsored by: Rep. Kurt Schrader
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To express the sense of Congress with respect to enabling Food and Drug Administration scientific engagement. [HB-2445]
To express the sense of Congress with respect to enabling Food and Drug Administration scientific engagement. This bill expresses the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the Food and Drug Administration.
Sponsored by: Rep. Brett Guthrie
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing. [HB-2444]
To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing. This bill authorizes the Commissioner of Food and Drugs to award grants to institutions of higher education and nonprofit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
Sponsored by: Rep. Brett Guthrie
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics. [HB-2443]
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics. This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.
Sponsored by: Rep. Brett Guthrie
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs. [HB-2438]
To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs. This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.
Sponsored by: Rep. Chris Collins
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. [HB-2433]
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.
Sponsored by: Rep. Gus Bilirakis
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. [HB-2428]
To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications. This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. [HB-2427]
To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to provide an opportunity for a person whose premarket submission for a medical device is subject to review by a classification panel to provide recommendations on the expertise needed among the members of the panel. The FDA must consider these recommendations and ensure that panels include at least two members with expertise clinically relevant to
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
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. [HB-2426]
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
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards. [HB-2425]
To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards. This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part,
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept. [HB-2424]
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
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence. [HB-2423]
To amend the Federal Food, Drug, and Cosmetic Act with respect to valid scientific evidence. This bill amends the Federal Food, Drug, and Cosmetic Act to define “valid scientific evidence” to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.
Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment. [HB-2422]
To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers are allowed
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes. [HB-2416]
To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements. "Evidence from clinical experience"
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Sponsored by: Rep. Michael Burgess
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. [HB-2415]
To amend the Federal Food, Drug, and Cosmetic Act to provide for establishment of a streamlined data review program. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a streamlined data review program under which the holder of an approved application for a drug or biological product may submit a summary of clinical data to support approval of the drug for the treatment of cancer or another indication subject to the program. For a drug to be eligible for the streamlined data review
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Sponsored by: Rep. Eliot Engel
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
To facilitate the responsible communication of scientific and medical developments. [HB-2414]
To facilitate the responsible communication of scientific and medical developments. This bill requires the Department of Health and Human Services to issue draft guidance on the dissemination of scientific and medical information that is not included in the approved labeling of drugs and medical devices.
Sponsored by: Rep. Kurt Schrader
Referred To The Subcommittee On Health. on 05/22/2015
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US Congress 114th Congress
SOFTWARE Act Sensible Oversight for Technology which Advances Regulatory Efficiency Act [HB-2396]
SOFTWARE Act Sensible Oversight for Technology which Advances Regulatory Efficiency Act This bill amends the Federal Food, Drug, and Cosmetic Act to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components, and is for: administrative or operational support or the processing and maintenance of financial records; use in clinical, laboratory,
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 05/22/2015