FDA Delays Modernization of QSR and CMS Assigns Reimbursement Code to Pain Management Device

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Regulatory News

Fall Regulatory Agenda: FDA Delays Release of Several Proposed Rulemakings

in April 2020, FDA expects to publish a proposed rule on the modernization of the quality system regulation for medical devices. FDA previously said it would publish the proposed rule last September. FDA also delayed its proposed rulemaking on excluding certain medical software functions from the definition of a device until next May. The agency previously said the proposed rule was coming in December. (RAPS 2019-11-20)

Eudamed to Launch in 2022 for Both Devices and IVDs

The European Commission recently concluded that its database of medical device information (Eudamed) will only be operational once all modules are fully functional and an independent audit has been conducted, so the commission has decided to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. (RAPS 2019-10-30)

Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices

Under the proposal, certain devices could be marketed under a provisional approval based on a demonstration of safety and performance in addition to other risk mitigations for a three-year period. Afterward, the sponsor would be required to demonstrate a reasonable assurance of safety and effectiveness based on postmarket data to continue marketing the device. (RAPS 2019-11-05)

IMDRF Offers Three Final Clinical Guidelines

The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, The guideline provides an overview of the general principles of clinical evaluation for medical devices, in vitro diagnostics (IVDs) and software as a medical device (SaMD) products. It discusses a range of issues including data sources and documentation, appraising and analyzing clinical data and compiling a clinical evaluation report. (RAPS 2019-11-11)

Quality and Software Issues Remain Top Reasons for Medical Device Recalls

For the 14th quarter in a row, software was the leading reason for a medical device recall. companies will be best served by thinking through what recall management means in 2020 and beyond, particularly as devices become smarter and more connected online, (MedTech Intelligence 2019-11-12)

FDA Launches EtO Sterilization Master File Pilot Program

The goal of the voluntary program is to “streamline the submission process, so that sterilization providers that sterilize single-use medical devices using fixed chamber sterilization processes may submit a Master File to the FDA when making certain changes between sterilization sites, or when making certain changes to sterilization processes that utilize reduced ethylene oxide concentrations.” (MedTech Intelligence 2019-11-25)

Payment News

CMS assigns new reimbursement code to ultrasound therapy device

A unique level II product reimbursement code has been assigned to NanoVibronix for its product PainShield, which is a pain management device that uses ultrasound therapy to provide an alternative to opioids. The new code, effective in January of 2020 was deemed necessary to provide a payment pathway for home ultrasound therapy, which had previously only been reimbursable for use in clinical settings.  (PR Newswire 2019-11-18)

CMS assigns new reimbursement code for microprocessor leg brace

Ottobock’s C-Brace has been assigned a new level II reimbursement code, inclusive of all components (e.g. sensors, batteries and charger) within the system of the microprocessor controlled “knee ankle foot device”.  This new code represents the first instance in which a microprocessor orthosis will not have to be billed using a miscellaneous code. The code is effective in January 2020. (AOPA In Advance SmartBrief 2019-11-14)

Germany expands coverage for digital health solutions

A new law passed in November enhances digital healthcare provision via low-risk medical devices for German patients. Reimbursement coverage will be provided contingent on the inclusion of the digital solution in a register of medical devices, and after the collection of 12 months of data showing proper evidence of safety, functionality and quality.  This new legislation is a milestone in digital healthcare for Germany and for other countries seeking to modernize medical device reimbursement regulations. (Lexology 2019-11-15)

The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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