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To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards.
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
37pct
3d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
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, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.) The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (2)
2016 · fourth_quarter · Medicare/Medicaid
Update and reforms to Medicare payments for physicians and implementation of related provisions of the Medicare Access and CHIP Reauthorization Act, and Medicare Part B reimbursement for prescription drugs, including the CMS Part B Drug Demonstration proposed rule; In-Office Ancillary Services; issues related to adequate and accurate network coverage for dermatologic care within Medicare Advantage plans; legislative issues regarding Exemptions from Meaningful Use of Electronic Health Records, including provisions in H.R.2425 - the Patient Access and Medicare Protection Act and S. 2511, Improving Health Information Technology Act; Medicare reimbursement for telemedicine; Medicare RAC reform and H.R. 2568, the Fair Medical Audits Act.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2016 · third_quarter · Medicare/Medicaid
Update and reforms to Medicare payments for physicians and implementation of related provisions of the Medicare Access and CHIP Reauthorization Act, and Medicare Part B reimbursement for prescription drugs, including the CMS Part B Drug Demonstration proposed rule; In-Office Ancillary Services; issues related to adequate and accurate network coverage for dermatologic care within Medicare Advantage plans; legislative issues regarding Exemptions from Meaningful Use of Electronic Health Records, including provisions in H.R.2425 - the Patient Access and Medicare Protection Act and S. 2511, Improving Health Information Technology Act; Medicare reimbursement for telemedicine; Medicare RAC reform and Fair Medical Audits Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medicare/Medicaid
Update for Medicare payments for physicians and Medicare Part B reimbursement for prescription drugs, including the CMS Part B Drug Demonstration Proposed Rule; In-Office Ancillary Services; CMS implementation of Medicare global surgery payment policy and elimination of 90 and 10 day global codes, including related provisions in H.R. 2, the Medicare Access and CHIP Reauthorization Act, and H.R. 6, the 21st Century Cures Act; issues related to adequate and accurate network coverage for dermatologic care within Medicare Advantage plans; legislative issues regarding Exemptions from Meaningful Use of Electronic Health Records, including provisions in H.R.2425 - the Patient Access and Medicare Protection Act and S. 2511, Improving Health Information Technology Act; Medicare reimbursement for telemedicine; Medicare RAC reform and Fair Medical Audits Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Medicare/Medicaid
Update for Medicare payments for physicians and Medicare Part B reimbursement for prescription drugs; In-Office Ancillary Services; CMS implementation of Medicare global surgery payment policy and elimination of 90 and 10 day global codes, including related provisions in H.R. 2, the Medicare Access and CHIP Reauthorization Act, and H.R. 6, the 21st Century Cures Act; issues related to adequate and accurate network coverage for dermatologic care within Medicare Advantage plans; and legislative issues regarding Exemptions from Meaningful Use of Electronic Health Records, including provisions in H.R.2425 - the Patient Access and Medicare Protection Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
HR 6, 21st Century Cures Act, all sections relating to vision. HR 1192, NationalDiabetesClinical Care Commission Act, all sections relating to vision. HR 1312, National Health Service Corps Improvement Act of 2015, all sections relating to vision. HR 1741, Truth in Healthcare Marketing Act, all sections relating to vision. HR 2029, Consolidated Appropriations Act, 2016, all sections relating to vision. HR 2371, Broadening Opportunities Through Education Act, all sections relating to vision. HR 2425, To amend the Federal Food, Drug, and Cosmetic Act with respect to the recognition of standards. S 586, NationalDiabetesClinical Care Commission Act, all sections relating to vision. S 898, National Health Service Corps Improvement Act, all sections relating to vision.
Client expense: $400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Medicare/Medicaid
Update for Medicare payments for physicians and Medicare Part B reimbursement for prescription drugs; In-Office Ancillary Services; CMS implementation of Medicare global surgery payment policy and elimination of 90 and 10 day global codes, including related provisions in H.R. 2, the Medicare Access and CHIP Reauthorization Act, and H.R. 6, the 21st Century Cures Act; issues related to adequate and accurate network coverage for dermatologic care within Medicare Advantage plans; and legislative issues regarding Exemptions from Meaningful Use of Electronic Health Records, including provisions in H.R.2425 - the Patient Access and Medicare Protection Act.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE