FDA Expands eSTAR Filing To De Novo Devices, IVDs

 In Blog, News, Regulatory & Reimbursement Update


FDA expands eSTAR filing to de novo devices, IVDs

US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kicked off in 2020 began with a template for 510(k) device submissions. Nine companies participated in that pilot program that trialed the interactive, PDF-based filing format. Use of eSTAR was expanded in September 2020 to include all 510(k) filers, except those submitting applications for combination products. In September 2021, FDA issued a draft guidance for how to use the electronic submission template for 510(k) submissions.

RAPS- 02 Dec 2021

EC outlines rules for electronic IFU for med devices

The European Commission has issued rules outlining the circumstances in which medical device instructions for use (IFU) can be provided in electronic form, rather than in paper form. The implementing regulation brings the European Union into alignment with device regulators in the US, Australia, and other nations, which already allow electronic labeling/IFU for certain medical devices. The electronic provision of IFU will be allowed for implantable and active implantable medical devices and their accessories, fixed installed medical devices and their accessories, and medical devices and accessories fitted with a built-in system to visually display the IFU. Devices and accessories must be intended exclusively for professional use. The device’s label should indicate that the IFU are supplied in electronic, rather than paper, form.

RAPS- 16 Dec 2021

EU finalizes implementing regulation for Eudamed medical device database

The European Commission has posted an implementing regulation for the Eudamed medical device database, providing a framework for the basic operation of the system which is meant to meet the information exchange needs of the medtech sector in implementing the EU Medical Device and In Vitro Diagnostic Regulations. In the document the Commission explains how to access the database, what it will do in the event of a database malfunction and its IT security measures. The publication of the implementing regulation follows the release of documents on the Eudamed Notified Bodies and Certificates and unique device identifier registration modules for the delayed database. The Commission has targeted a May 2022 launch for the complete system, which was supposed to be ready by the original MDR date of application in 2020.

RAPS- Dec 02 Dec 2021

MDCG offers new guidance on clinical investigations, importers and distributors

The European Commission’s Medical Devices Coordination Group (MDCG) issued new guidance documents offering questions and answers on the import and distribution of medical devices. The group also provided sponsors with a template for notifying member states of a substantial modification to a clinical investigation, to be used as a stopgap before the Eudamed electronic reporting system is fully functional. In its 11-page questions and answers guidance on Articles 13 and 14 of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), MDCG discusses the roles and responsibilities of importers and distributers under the two regulations. The guidance offers insight on distinguishing between the two roles and general obligations under the regulations. Also addressed are specific obligations for verifying that products are CE marked and are in compliance with registration and other requirements. The guidance also offers several practical examples of different situations involving the import or distribution of medical devices and IVDs.

RAPS- 09 Dec 2021


CMS Expands coverage for continuous glucose monitoring

In a final rule issued on December 21, the Centers for Medicare and Medicaid Services (CMS) finalized payment provisions for continuous glucose monitoring (CGM) coverage under the benefit category of durable medical equipment. The coverage language was updated from the term “injections” to “administrations” of insulin, which allows for a wider range of technologies, including insulin pumps and inhaled insulins. Another update was the language around the testing requirements, which had previously specified that testing should take place four times per day. Flexibility around this requirement opens the door to newer technologies that offer continuous feedback.

(Healio 12/22/21)

Telehealth evolution beyond the pandemic

Telehealth experienced a sharp rise in popularity at the beginning of the COVID pandemic and is expected to maintain a prominent place in the healthcare continuum. Experts expect that ¼ of patient visits will be telehealth visits in the next 5 years. Mental healthcare has seen the largest benefit from the telehealth expansion. Follow-up care from surgeries is another area where telehealth can lighten patient burden. A third area of strength for telehealth is remote patient monitoring for chronic care, such as for patients with diabetes. These rapid telehealth advancements have been made possible by new reimbursement models that make virtual healthcare a practical alternative to traditional medicine.

(mHealthIntelligence 12/27/21)

Payer analysis company Reveleer raises $65M

Reveleer provides risk adjustment data analysis for government sponsored healthcare programs using an artificial intelligence enabled platform. Reveleer’s latest round of fundraising resulted in $65 million that will be used for continued product development. The company is looking to expand its analysis capabilities for value-based care in response to demand from payers.

(Fierce Healthcare 12/7/21)

Survey results show that telehealth may include more out of pocket payments

A patient survey conducted earlier in 2021 found that 67% of patients wanted the choice to have virtual healthcare visits. However, when asked about their willingness to pay out of pocket, 62% of those who had preferred the option of virtual visits, wanted an in-person visit if the cost was $30 or more. This may show a belief that a virtual visit does not provide equivalent care, or an impression that providers are putting in less effort during a video call than they would for an in-person visit. 34% of those surveyed said that they wanted all visits to be in-person. These respondents were more likely to be older, with lower income and educational levels and living in more rural areas. The researchers surmise that result may be a combination of this demographic group viewing telehealth as less valuable, and reduced perceived feasibility given personal circumstances such as limited technology literacy or broadband connectivity.

(Fierce Healthcare 125/21)

CMS final rule reduces DMEPOS payments in rural areas

In the DMEPOS final rule, published in December, the Centers for Medicare and Medicaid Services (CMS), made permanent the 50/50 blended reimbursement rates in rural areas. Stakeholders feel that this rule will help to increase access to DMEPOS items for patients in “often-underserved communities and offsetting the higher costs of supporting patients over a wider geographical footprint.” This action enhances patient’s ability to obtain home respiratory supplies, equipment, and services, which is especially important for patients recovering from COVID and other acute and chronic respiratory conditions.

(HME News 12/21/21)

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 Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.

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