For member companies impacted by Hurricane Idalia, Governor DeSantis recently activated the Florida Small Business Emergency Bridge Loan Program, making $20 million available for short-term, zero-interest loans to small businesses. Interested applicants can apply now through October 25, 2023. Businesses in the following counties, including sole proprietors, are eligible to apply: Alachua, Baker, Bradford, Citrus, Columbia, Dixie, Franklin, Gilchrist, Hamilton, Hernando, Hillsborough, Jefferson, Lafayette, Leon, Levy, Madison, Manatee, Marion, Pasco, Pinellas, Sumter, Suwannee, Taylor, Union and Wakulla counties.

Medical Device User Fees for Fiscal Year 2024

The FDA recently issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year 2024 (FY 2024), effective October 1, 2023. The establishment registration user fee for FY 2024 is $7,653, and there are no waivers or reductions for small establishments or businesses. Other fees for Fiscal Year 2023 are as follows:

The FDA is accepting Small Businesses Fee Reduction and Fee Waiver requests for FY 2024. Before submitting a request, you must be certified as a “small business.” Learn more at Reduced Medical Device User Fees: Small Business Determination (SBD) Program.

Voluntary Improvement Program

The U.S. Food and Drug Administration (FDA) recently issued the final guidance: Fostering Medical Device Innovation: FDA Activities and Engagement with the Voluntary Improvement Program. The Voluntary Improvement Program is facilitated through the Medical Device Innovation Consortium and uses third-party appraisals to evaluate a medical device manufacturer’s practice, and their capability and performance in producing high quality devices. The guidance outlines the program’s features, benefits, operations, and eligibility considerations.

Reminder: eSTAR and CDRH Portal are Required for 510(k) Submissions

The FDA is reminding all medical device submitters that starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR through the CDRH Portal as noted in the Electronic Submission Template for Medical Device 510(k) Submissions final guidance. eSTAR is the only available electronic submission template to facilitate the preparation of 510(k) electronic submissions.

Use of International Standard ISO 10993-1 (Biocompatibility) / Webinar

The FDA recently issued the final guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.” The final guidance reflects the FDA's current thinking about the type of biocompatibility information that should be provided in a medical device premarket submission for certain devices in contact with intact skin (see Attachment G of the guidance). On October 12, 2023, the FDA will host a webinar for industry and others interested in learning more about the guidance.

Modernizing the Premarket Notification 510(k) Program

The FDA recently issued the following three draft guidances intended to support efforts to continue to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices as they become more complex and innovative:

• Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
• Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
• Evidentiary Expectations for 510(k) Implant Devices

Breakthrough Devices Program & Health Equity

The FDA recently issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities.

Medical Device Development Tools

The FDA recently announced the qualification of a new tool through the voluntary Medical Device Development Tools (MDDT) program: Accelerated Testing to Prove Long-Term Material Biostability. The new MDDT is a non-clinical assessment model intended to assess long-term hydrolytic biostability of thermoplastic polyurethane materials being considered for cardiac or neuromodulation lead insulation. 

Off-The-Shelf (OTS) Software

The FDA recently issued the final guidance Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff. This guidance document provides information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off-the-shelf (OTS) software used in a medical device.

Public Meeting: Modernizing Recalls of FDA-Regulated Commodities

The FDA is announcing a public meeting titled Modernizing Food and Drug Administration Recalls Listening Session, to be held Friday, September 29, 2023 (9:00 a.m. to 5:00 p.m. ET/Virtual & In-Person). The purpose of this public meeting is to provide an opportunity for stakeholders to share information and feedback about topics related to recall modernization for FDA-regulated products.

Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot

The FDA recently announced that beginning October 1, 2023, the TAP Pilot will expand to include devices in the Office of Neurological and Physical Medicine (OHT5). TAP is intended to help ensure that U.S. patients have access to high-quality, safe, effective, and innovative medical devices first in the world for years to come by promoting early, frequent, and strategic communications between the FDA and medical device sponsors.

Hydrogen Peroxide-Based Contact Lens Care Products

The FDA recently issued the final guidance: Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions. This final guidance provides labeling recommendations for manufacturers of hydrogen peroxide-based contact lens care products for inclusion in premarket notification (510(k)) submissions.

Medical Device Shortages List

The FDA recently updated the Medical Device Shortages List web page to remove the following product codes:

• Specimen Collection – Testing Supplies and Equipment (codes: JKA, GIM, and KXG)
• Laboratory Reagents and Testing Supplies – Testing Supplies & Equipment (product codes: QOF, JRC, LXG, PPM, NSU, OOI, and JJH)
• Transport Media Device – Testing Supplies & Equipment (codes: LIO, QBD, and JSM)
• Saline, Vascular Access Flush – General ICU/ Hospital Products (product code: NGT)
• Certain Ventilation-Related Products – (product codes: BZD, MNS, and MNT)
• Oxygenators intended for extracorporeal circulation (product codes: DTZ and BYS)

Electronic Medical Device Export Documents

The FDA recently announced that, in December 2023, it will begin transitioning from paper export documents for medical devices to electronic export documents. Starting January 2, 2024, requestors and foreign governments will be able to verify the authenticity of an export certificate through the FURLS Export Certificate Validator (FECV) database. The FDA will include a link to the FECV database at the bottom of each certificate.

Miscellaneous

• Tips for Submitting Comments on CDRH Guidance Documents
• Medical Device Shortages List (Updated)
• Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations - Draft Guidance for Industry and Food and Drug Administration Staff
• Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
• Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program - Guidance for Industry and Food and Drug Administration Staff
• MDUFA Reports (Updated)
• September 2023 MDUFA V Performance Report
• September 2023 MDUFA IV Performance Report
• Postmarket Device Safety-Related Communications Report to Congress

Florida Workers’ Compensation Rates Continue Decline

For the 7^th straight year, the National Council on Compensation Insurance (NCCI) has proposed an average 15.1% Workers’ Compensation (WC) premium decrease in Florida for 2024. The filing must be reviewed and approved by the Florida Office of Insurance Regulation to go into effect. This NCCI filing was based on experience data from policy years 2020 and 2021 and comes despite upward pressure on medical costs noted in the analysis.

State Budget Surpluses Strong but Trending Downward

The Joint Legislative Budget Commission met recently to review Florida’s long-range financial outlook. The conclusion was Florida’s budget picture remains healthy with a forecasted general-fund surplus of $7 billion projected for fiscal year 2024-2025. However, it was noted that these budget surpluses are trending downward to $2.72 billion forecasted by fiscal year 2026-2027.

Apprentice Florida & Workforce Development Month

September is Workforce Development Month and it’s a time to recognize the contributions of workforce professionals and the importance of equipping Floridians with the education, training and skills needed to advance their careers and bolster our economy. Registered apprenticeship programs are a proven solution for businesses to recruit, train and retain highly skilled workers. One innovative effort is Apprentice Florida, a partnership between the Florida Department of Education, CareerSource Florida and FloridaCommerce. Apprentice Florida provides businesses with information and resources to establish or expand registered apprenticeship programs, which are a proven solution for businesses to recruit, train and retain highly skilled workers. Learn more HERE.

Florida Imposes a Ban on Offshoring Storage of Medical Information [National Law Review]

Florida medical tech company launches novel AI test for prostate cancer therapy [FOX News]

Medical devices more affordable in Florida with elimination of tax [Florida Times Union]

Florida health insurance rate better, still lags rest of the country [Orlando Sentinel]

This device could help prevent strokes during surgery [Medical Design & Outsourcing]

Florida Medicaid enrollment declines 7% as the state pushes for eligibility verification [Capitolist]