Regulatory

Medtech groups want more time to implement FDA’s QMSR rule

While the medtech industry is overwhelmingly supportive of the long-awaited proposed Quality Management System Regulation (QMSR) rule, several stakeholders have asked FDA for clarifications. They argue that the one-year transition period as proposed by FDA would be especially burdensome for smaller medtech manufacturers. “We believe that a 12-month effective date is too brief and instead offer a three-year effective date, which would give everyone ample time to transition, especially small US companies who have never operated under ISO 13485,” said the Medical Device Manufacturers Association (MDMA) in their comments to FDA. “The longer timeline also ensures that [outside the US] companies who are used to operating under ISO 13485 are not given preference over US companies who are new to the regulation,” they added. “Alternatively, we encourage FDA to implement a ‘phase in’ approach where the current version of the QSR remains effective for 3 years, the QMSR rule becomes effective relatively quickly, and companies may then choose to which version they want to comply.”

RAPS 05/25/2022

510(k) Sterility Change Master File Pilot Program

The 510(k) Sterility Pilot Program is voluntary and intends to give interested companies that terminally sterilize single- use devices using certain sterilization methods a pathway to submit a Master File for FDA’s review. FDA will accept a Master File into the 510(k) Sterility Pilot Program when it determines that there is not a likelihood that switching from a fixed chamber ethylene oxide (EtO) sterilization method to the sterilization method described in the Master File could significantly affect the safety or effectiveness of a 510(k)-cleared device. If accepted, the manufacturer may choose to reference the Master File in internal documentation in support of a justification for not submitting a new premarket notification (510(k)). This voluntary pilot program seeks to encourage industry to consider new, innovative ways to sterilize devices that reduce the potential impact of EtO on the environment and on public health, while ensuring consistent patient access to safe devices.

FDA 05/20/2022

MDCG guidance aims to help manufacturers implement UDIs under MDR and IVDR

The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). The 14-page document covers 25 questions regarding UDI device identifiers (UDI-DI), UDI labeling, UDI rules for systems and procedures packs and configurable devices, and whether UDI rules apply to retail point of sale, promotional packs and marketing samples.

CDRH plans return to normal pre-submission timelines

The head of the US Food and Drug Administration’s (FDA) device center says the agency is planning to get back to normal pre-submission timelines soon. His office hit the pause button for certain pre-submission meetings and delayed others to conserve its resources during the COVID-19 pandemic. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), said, “Starting fairly soon,” FDA will reopen its pre-submission doors after the agency had to make some tough choices about the program last year. In April 2021, FDA announced it would only accept pre-submission meetings for in vitro diagnostics (IVDs) if they were related to the COVID-19 pandemic, companion diagnostics, breakthrough designation requests, or those with a significant public health impact. All other IVD pre-submission meetings were put on hold because the agency did not have enough staff to allocate to those meetings. For other medical devices, the agency offered an extended timeline; 120 days instead of the normal 70 days.

RAPS: May 04^th, 2022

IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback

Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from the International Medical Device Regulators Forum (IMDRF). The draft is the result of feedback from a 2020 guidance that stakeholders said did not sufficiently address legacy products. The draft guidance, published 4 May, outlines what is considered a legacy device, and how stakeholders can keep them safe from cybersecurity threats. The guidance follows the 2020 IMDRF document, which included a framework for legacy devices, but was intended to broadly outline how medical devices in general can be designed and maintained.

RAPS: May 6^th, 2022

US FDA moves forward with Voluntary Improvement Program to bolster medical device quality

The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program. The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018. That preliminary effort was called the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, or CfQ Pilot Program.

EMERGO: MAY 18^th, 2022

Payment

Public Health Emergency expected to be extended through the Fall 

The Department of Health and Human Services (HHS) has a self-imposed policy to provide a 60-day period of notice before ending the Public Health Emergency (PHE). That deadline was surpassed on May 16^th, which suggests that the PHE will be extended past its current end date of July 15, 2022. The PHE provides relaxation to regulatory and reimbursement policies for healthcare services, including telehealth.

(Lexology 5/23/22)

Evidence that telehealth expansion may not increase disparities among low-income patients

A Johns Hopkins study examined Medicare claims for 30 million patients from 2019-2021. The findings showed that the COVID-related expansion of reimbursement for telehealth resulted in increased utilization of telehealth in urban areas and among minority and low-income populations. Before the reimbursement expansion, .4% of patients had undergone at least 1 telemedicine visit. After the expansion, this rate had risen to 10%. The findings of this study contradict prior studies which had found a direct relationship between income and telehealth utilization.

(Fierce Healthcare 5/6/22)

NICE endorses the use of digital therapeutics instead of pills for insomnia

The National Institute for Health and Care Excellence (NICE), which provides guidance for the National Health System in the United Kingdom issued a recommendation in favor of the digital therapeutic Sleepio. NICE estimated that hundreds of thousands of patients who would usually be prescribed sleeping pills could be prescribed the app-based treatment instead. The Sleepio program is designed to last 6 weeks and includes sessions on identifying and modifying thoughts, feelings and behaviors that lead to a disrupted sleep pattern. The endorsement decision was made as a result of clinical evidence that showed Sleepio to be more effective and cost saving compared to standard pharmaceutical treatment protocols.

(NICE 5/20/22)

Hospitals charge commercial health plans more than double Medicare rates

A Rand study funded by the Robert Wood Johnson Foundation found significant hospital pricing variations throughout the country. States including Hawaii, Arkansas and Washington had commercial plan pricing below 175% of Medicare. States including Florida, West Virginia and South Carolina had prices in excess of 300% of Medicare pricing. The overall results showed that employers and private insurance companies paid an average of 224% of Medicare pricing in 2020. These findings show a slight smaller discrepancy compared to a similar study completed in 2018 that found the pricing difference to be 247%. The American Hospital Association responded to the study by stating that variation is to be expected across the wide range of hospital types in the country. They also criticized the report’s methods and stated the Rand report should have used a larger variety of claim types for analysis.

(HealthCare Dive 5/18/22)

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, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, and Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation.  A story’s inclusion does not imply endorsement by Simbex.