Final Rule Amending FDA’s Quality System Regulation Issued

The U.S. Food and Drug Administration (FDA) issued today the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule amends the current good manufacturing practice requirements of the Quality System regulation in 21 CFR 820; and harmonizes key areas with the international standard (ISO 13485:2016), emphasizing risk management activities and risk-based decision making. Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026. Learn more.

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance is an update to the current final guidance to propose clarification about how the FDA evaluates real-world data to be used in the FDA’s regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to sponsors considering using real-world evidence to support regulatory submissions for medical devices.

CDRH’s Office of Strategic Partnerships and Technology Innovation Elevated

The FDA recently announced organizational changes within the Center for Devices and Radiological Health (CDRH), elevating the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office within the Center. By elevating OST to a Super Office, several organizational shifts will occur, including the establishment of the following five offices within OST: Office of Supply Chain Resilience (OSCR); Digital Health Center of Excellence (DHCoE); Office of Technology and Data Services (OTDS); Office of Readiness and Response (ORR); and Office of Equity and Innovative Development (OEID)

Characterization of Metallic and/or Calcium Phosphate Coatings on Orthopedic Devices

The FDA recently issued the draft guidance: Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices. This guidance, once finalized, will provide recommendations for manufacturers to help promote consistency and facilitate efficient review of premarket submissions for orthopedic devices with metallic, calcium phosphate, or dual coatings of these materials.

Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge Winners

The FDA recently announced the five winners of the Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge. The V-CHAMPS Challenge intends to encourage the development of artificial intelligence and machine learning (AI/ML) models to predict heart failure related outcomes -- including hospitalization, readmission, and mortality.

New Digital Health Advisory Committee

The FDA recently announced the creation of a new Digital Health Advisory Committee (DHAC) to help the agency explore the complex scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software

Predetermined Change Control Plans in AI/ML-Enabled Medical Devices

The FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles. The five guiding principles outline key characteristics of robust Predetermine Change Control Plans.

Resource for Digital Health Developers

The FDA has published a list of frequently asked questions (FAQs) to help answer common questions about bringing safe and effective digital health technologies to market.

Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile

The FDA recently updated the final guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The FDA now considers vaporized hydrogen peroxide (VHP) as an Established Category A sterilization process. The updated guidance provides industry with revised recommendations on the information to provide in future 510(k) submissions that use VHP. Moving VHP from Established Category B to Established Category A reduces the regulatory burden on manufacturers using this sterilization process for devices that need a 510(k).

Electronic Export Documents for Medical Devices

Starting January 2024, the FDA now issues electronic export documents for medical devices rather than paper documents. At this time, foreign governments and others can verify the authenticity of an electronic export certificate through the FURLS Export Certificate Validator (FECV). The FDA will include a link to the FECV at the bottom of each certificate.

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

The FDA recently issued the final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, which provides industry, investigators, and other stakeholders recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products.

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

The FDA issued the draft guidance, 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review, which describes updates to the 510(k) Third Party Review program and addresses how the FDA may rely on third parties to review EUA requests to enable the FDA to rapidly expand its resources during a future emergency. 

FDA Participates in Three New Collaborative Communities

The FDA’s Center for Devices and Radiological Health (CDRH) began participating in three new collaborative communities in the medical device ecosystem:

• AI Global Healthcare Initiative Collaborative Community: Seeks to advance current approaches to improve patient health, product quality, and process improvement through the power of artificial intelligence (AI) and collaboration.
• Infection Management Collaborative Community: Aims to accelerate the development, availability, and adoption of safe and effective medical devices to prevent, diagnose, and manage infection; treat sepsis; and support sepsis patients and survivors.
• Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD): Seeks to describe the same diagnostic test the same way anywhere it is used in the health care ecosystem.

Electronic Submission Template and Resource (eSTAR) for PMA Submissions

The FDA’s eSTAR is now available for voluntary use for certain PMA Submissions. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. The updated eSTAR Template includes a guide that follows the recommendations noted in the final guidance:

Classification of Certain Wound Dressings and Liquid Wound Washes

The FDA is proposing to classify certain unclassified, wound dressings and liquid wound washes containing antimicrobials or other chemicals into three separate classification regulations: solid wound dressings, wound dressings formulated as a gel, cream, or ointment; and liquid wound washes.

Miscellaneous

• List of Artificial Intelligence (AI) and Machine Learning (ML) Enabled Medical Devices
• Updates to the Medical Device Shortages List
• Presentation and Transcript for Medical Device Sterilization Town Hall: Overview of Sterilization Landscape and Role of Ethylene Oxide - (1/10/24)
• Presentation and Transcript for Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - (1/26/24)
• Presentation and Transcript for Webinar - Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions Final Guidance - (1/11/24)
• Meeting Notice: February 13, 2024 Circulatory System Devices Panel of the Medical Devices Advisory Committee
• CDRH 2023 Annual Report
• Report to Congress: Device Pilot Projects FY 2022

Bi-Partisan Tax Deal Emerges in Congress, Surprisingly

House Ways and Means Committee Chairman Jason Smith (MO-08) and Senate Finance Committee Chairman Ron Wyden (D-OR) recently announced agreement on the structure of bi-partisan tax legislation: The Tax Relief for American Families and Workers Act of 2024 (H.R. 7024). Section-by-Section summary HERE.

Most notably, the tax deal contains:

• Research & Development (R&D) expenses: restores full and immediate expensing of the cost of U.S.-based R&D investments instead of over five years. Taxpayers may deduct domestic research or experimental costs that are paid or incurred in tax years beginning after December 31, 2021, and before January 1, 2026.
• 100% bonus depreciation: retroactively extends full and immediate expensing for investments in machines, equipment, and vehicles. Applies to qualified equipment placed in service after December 31, 2022 until January 1, 2026.
• Business Interest deductibility: removes strict interest deduction limitations.
• Small business expensing cap: increases the amount of investment that a small business can immediately write off to $1.29 million, an increase above the $1 million cap enacted in 2017.

The legislation recently passed the House Ways & Means Committee with a large bi-partisan vote (40-3). A final House vote has not been scheduled but the legislation could go to the floor as early as the end of the week, pending negotiations with some GOP moderates supporting modifications to state and local tax (SALT) deduction limits.

Breakthrough Product Legislation Moves Slightly in House

The “Ensuring Patient Access to Critical Breakthrough Products Act of 2023” or the "Breakthrough" bill (H.R. 1691), introduced by a bipartisan group of original cosponsors, including Florida’s Rep. Gus Bilirakis., passed convincingly out the House Energy and Commerce Subcommittee on Health (21-6). This important legislation, which currently enjoys a bi-partisan roster of 78 cosponsors, would provide automatic Medicare coverage for four years for a limited number of breakthrough devices that the FDA approves and that address an unmet need for Medicare beneficiaries. However, the estimated budgetary impact of the bill ($7-$12 Billion) has stalled its forward legislative momentum, awaiting more refined fiscal “scoring” and the finalization of CMS’ Transitional Coverage of Emerging Technologies (TCET) rule, which would lessen the fiscal impact of H.R. 1691.

Meanwhile in Tallahassee at the 2024 Regular Session of the Florida Legislature........

State Budget

Gov. Ron DeSantis’ proposed $114 billion budget for FY 24-25 represents $4 billion reduction from last year’s state spending plan. The governor is proposing over $1 billion in tax reductions, including $431 million in cuts to taxes levied on homeowners insurance policies and a permanent insurance premium tax exemption on Flood Insurance ($22 million). The Revenue Estimating Conference met recently and increased the general revenue projections by $2.18 billion, which is good news for the ongoing budget building process. The Senate and House have already released their respective proposed state budgets for FY 2024-25. The Senate bill, SB 2500, proposes a total state budget of $115.9 billion The House bill, APC 24-01, recommends $115.5 billion in total spending for FY 24-25.

Sales Tax on Commercial Leases and Rents

Firms with commercial leases realized a 1% tax cut (from 4.5% to 3.5%) on their business rents December 1st thanks to legislation passed last session. And, based on a 2021 bill, that tax rate will decline to 2.0% once Florida’s Unemployment Compensation Trust Fund balance is replenished to pre-pandemic levels. Florida TaxWatch estimates this reduction would deliver $1 billion in business savings. A report from the Office of Economic and Demographic Research projects that this trust fund will reach full replenishment ($4.07 billion) in March 2024. Thus, this substantial reduction in the business rent tax will be effective June 2024 --- two months earlier than projected. The sales tax on commercial leases has been imposed since 1969, and there will be a push this session to further reduce or eliminate the tax altogether in a package of tax breaks that are typically crafted alongside the budget.

Florida Senate Focusing on Health Care

As expected, the Florida Senate is moving legislation announced by Senate President Kathleen Passidomo, which seeks to improve the delivery and cost of health care, including patient-focused innovations, Emergency Department overutilization, limited access in rural areas and workforce shortages. Parts of President Passidomo’s “Live Healthy” proposal, SB 7016 ($737 million) and SB 7018 ($50 million), have been passed unanimously by the full Senate. SB 7016 seeks to increase Florida’s health care workforce (including 500 new medical residency sots), removing regulations to increase workforce mobility and expanding access to health care. SB 7018 incentivizes health care innovation through technology. Four other Senate bills that are part of the Live Healthy proposal are currently moving through the committee process. Similar companion legislation in the House (HB 1549 and HB 1501) are also moving in that chamber.

Medical Malpractice

The Florida Legislature is also debating significant reforms to the state’s medical-malpractice laws, including limiting pain-and-suffering damages in lawsuits against doctors and hospitals. The Senate Judiciary Committee recently passed SB 248, which includes “non-economic damages” caps of $500,000 from doctors or practitioners and $750,000 in lawsuits against hospitals or other “nonpractitioners.” Lower caps have been previously passed by the Florida Legislature, but they have been struck down by Florida Supreme Court as unconstitutional. Companion legislation is the House (HB 77) has yet to heard in committee.

Local Tax Hikes

Legislation requiring a two-thirds vote by city, county and special district governing boards to approve increases in millage rates (property taxes) is moving in the both the House (HB 1195) and Senate (SB 1322). Under the legislation, a two-third votes would not be required when tax rates remain the same but property owners pay more because of increased values.

Per- and Polyfluoroalkyl Substances (PFAS) Legislation

Legislation has been filed in both chambers (SB 1692 and HB 1665) to create the Per- and Polyfluoroalkyl Substances (PFAS) and 1,4-Dioxane Pretreatment Initiative within the Department of Environmental Protection (DEP) to prevent these contaminants of emerging concern from entering the waters of the state through wastewater facilities. Ultimately, the legislation requires DEP and wastewater facilities to provide written notice to all identified industrial sources of these “forever chemicals” and issue user permits to enforce applicable pretreatment standards by July 1, 2027.

Surgical Smoke Abatement

Legislation (HB 63 and SB 410) under consideration in the Florida Legislature would require hospitals and ambulatory surgical centers to implement the use of surgical smoke evacuation systems. These systems must effectively capture, filter and eliminate surgical smoke at the site of origin before the smoke makes contact with the eyes or respiratory tract of people in the surgical suite.

• Report shows Florida wages are the highest they have been in last 20 years [Florida Politics]
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• Florida gets FDA approval for Canadian drug importation plan [Politico]
• Florida #1 in the Nation for Attracting and Developing Skilled Workforce [FloridaCommerce]
• State halts work on $154M Medicaid IT contract [FloridaPolitics]