FDA Issues Draft Guidance On Electronic 510(k) Submissions and CMS Proposes to Repeal MCIT

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FDA issues draft guidance on electronic 510(k) submissions

The US Food and Drug Administration (FDA) issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k). In the draft guidance, FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). On 30 September 2022, FDA will specify a date for when they will require 510(k) electronic submissions. eSTAR is “highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes targeted questions designed to collect specific data and information from the submitter. eSTAR also includes applicable links to regulations, relevant guidances, and other resources for the submitter’s reference.” The program is structured so that submitters can enter content and have it be assembled in the 510(k) submission format.

(RAPS:28th Sep 2021)

US FDA rolls out list of registered medical devices featuring artificial intelligence and machine learning

The US Food and Drug Administration has published an initial list of legally marketed medical devices that utilize artificial intelligence and machine learning (AI/ML) in order to provide more transparency to stakeholders and the public regarding increasing use of these technologies in healthcare settings. The list covers AI/ML devices that have either obtained 510(k) clearance, Premarket Approval (PMA) or De Novo request acceptance from FDA. The list currently contains 343 devices, and the agency plans periodic updates depending on publicly available information and data.

(EMERGO: 24th Sep 2021)

FDA continues data modernization with new Office of Digital Transformation

The US Food and Drug Administration (FDA) is moving forward in plans to modernize its data and information technology efforts with the launch of a new Office of Digital Transformation (ODT). “Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said acting FDA commissioner Janet Woodcock. “The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do,” added Woodcock. FDA took its first modernization steps in 2019 with the launch of its technology modernization action plan, which began to bring FDA’s submission review process up to date, among other modernization steps.

(RAPS: 16th Sep 2021)

FTC warns app makers fall under breach notification rule

The U.S. Federal Trade Commission issued a policy brief clarifying when healthcare apps would be subject to the Health Breach Notification Rule that requires entities not covered by HIPAA to notify consumers if private health information is compromised. The FTC said that developers of health apps and connected devices are considered healthcare providers, and if they disclose sensitive information without authorization that would be considered a breach.

The agency also noted that a breach must be reported regardless of whether it was the result of malicious action. Any unauthorized access, including sharing information without consent, would trigger the rule

(MEDTECHDIVE: 16th Sep 2021)

MHRA floats overhaul of medical device regulation in public consultation

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has advanced its effort to set up a post-Brexit regulatory environment by initiating a consultation on medical device regulation and establishing a work program for software and artificial intelligence (AI).The UK currently assigns medical devices to Class I, IIa, IIb or III based on their risk. MHRA is proposing to retain the basic structure but move certain types of devices to new risk categories. The changes proposed by MHRA, such as assigning active implantable devices and surgical mesh to Class III, are intended “to reflect changes in technology and better account for how medical devices are used – including the level of invasiveness and potential toxicity of certain devices.” MHRA is considering allowing companies to use approvals from other countries or Medical Device Single Audit Program (MDSAP) certificates to bring products to the UK market. New regulatory regime is scheduled to take effect in July 2023 “with appropriate transitional arrangements.” MHRA selected the date to align with when it will stop accepting CE-marked medical devices.

(RAPS 9/20/21)


CMS proposes to repeal MCIT

The Centers for Medicare and Medicaid Services (CMS) issued a proposal to repeal the Trump-era rule entitled Medicare Coverage of Innovative Technology (MCIT). The bipartisan bill was supposed to take effect in December 2021 after having been delayed during the administration change. CMS now states that it believes MCIT would not be in the best interest of its beneficiaries because of fears of coverage without “adequate evidence” of clinical benefit in a Medicare population. A 30-day public comment period opened on September 15th.

(RevCycleIntelligence, 9/14/21)

Digital Therapeutics Alliance announces new reimbursement partnership with Eversana

The Digital Therapeutics Alliance (DTA) launched a new initiative called the DTA Resource Partner Program. The goal is to build a network of commercialization and product development service providers to advance digital therapeutics. Resource Partners have been screened and vetted by DTA. Eversana, a commercial services company -designed to solve pricing, access, reimbursement, adherence and product delivery challenges, was named as one Resource Partner and has already begun working with MedRhythms to launch and commercialize their digital therapeutic product.

(Yahoo Finance, 9/23/21)

Pear Therapeutics announces that more than 30 organizations provide access

In a late-September press release, Pear Therapeutics announced that they had achieved a milestone of over 30 organizations providing coverage for their prescription digital therapeutic products. Coverage has been achieved through a combination of listing on formularies, covered benefits, and bulk purchasing. Pear is continuing to work with payors to add more prescription digital therapeutics as a standard covered benefit in order to help improve accessibility to care.

(Business Wire, 9/23/21)

New comparison tool for nursing home vaccination status

The Centers for Medicare and Medicaid Services (CMS), has released a new comparison tool for the public to view COVID-19 vaccination rates at individual nursing home facilities. The tool is available on the CMS Care Compare website. The reported data will be updated bi-weekly and will help families select facilities and monitor data in their areas. Current estimates are that 84% of nursing home residents and 64% of nursing home staff have been vaccinated nationwide.

(McKinghts Long Term Care News, 9/21/21)

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 Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, 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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