Regulatory

FDA nixes GUDID submission requirements for class I consumer healthcare devices

Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance. Under the agency’s unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaining devices, will be subject to standard date formatting, UDI labeling, and GUDID data submission requirements no earlier than 24 September 2022. However, in the draft guidance, which will revise and supersede Section III of the compliance policy when finalized, FDA explains that it does not plan to enforce GUDID submission requirements for consumer healthcare products, though it still plans to enforce standard date formatting and UDI labeling requirements for such devices after 24 September 2022.

(RAPS: 14 October 2021)

CDRH outlines guidance plans for FY2022

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearances from last year’s list. As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft and final guidances, which CDRH says it will publish as resources permit. New guidances making the A-list as drafts to be issued in FY2022 include documents entitled Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.

(RAPS 26 October 2021)

FDA finalizes long delayed de novo classification rule

The US Food and Drug Administration (FDA) issued a final rule setting requirements for the medical device de novo classification process, codifying procedures and criteria for new types of medical devices to be authorized as Class I or Class II devices. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also intended to limit the unnecessary expenditure of FDA and industry recourses that may occur if devices for which general controls and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval.

(RAPS: 05 October 2021)

New MDCG guidance shows how devices fit into MDR’s classification rules

The European Commission’s Medical Devices Coordinating Group (MDCG) issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market. Under the MDR, which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest. Annex VIII of the MDR further categorizes devices as non-invasive, invasive oractive, or falling into another “specials rules” category for contraceptives, contact lens solutions and device sterilizers.

(RAPS: 06 October 2021)

FDA Collaborates with Health Canada and UK’s MHRA to Foster Good Machine Learning Practice

The U.S. Food and Drug Administration, Health Canada and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly issued the “Good Machine Learning Practice for Medical Device Development: Guiding Principles” to identify a set of ten guiding principles that are important to be included in the development of Good Machine Learning Practice (GMLP). Good Machine Learning Practice is intended to advance high quality artificial intelligence/machine learning enabled medical device development. These ten principles are intended to identify areas where alignment in efforts related to research, building resources and tools, regulatory policies, regulatory guidelines, international harmonization and consensus standards could be developed by the IMDRF, international standards organizations and other collaborative bodies to advance the maturation of GMLP.

(RAPS: 27 October 2021)

Payment

Anthem expands coverage of microprocessor prosthetic devices

The move to expand coverage of advanced prostheses such as microprocessor knee and ankle joints came as a response to a class action filed in California. Anthem has agreed to cover these prosthetic components if certain criteria are met. Anthem had previously denied payment for these devices, categorizing them as “investigational” but the plaintiffs disagree, stating that microprocessor prostheses are accepted by the medical community and routinely prescribed for patients with limb loss.

(Bloomberg Law 10/21/21)

NanoVibronix signs agreement with a leading national workers compensation payer

PainShield, which is a product of NanoVibronix will now be available for patients receiving benefits under worker’s compensation plans that are administered by Orchid Medical. PainShield is a portable ultrasonic therapeutic device that provides pain management via localized ultrasound effect. Under the agreement, NanoVibronix will provide PainShield kits and disposables at a fixed price to Orchid Medical. The agreement will renew automatically each year.

(Yahoo Finance 9/29/21)

British Columbia improves access to prosthetics and orthotics

Patients in British Columbia, the westernmost Canadian province, will benefit from increased reimbursement for orthotic and prosthetic care provided by BC PharmaCare. ““Prosthetic and orthotic devices help improve people’s health and quality of life,” said Adrian Dix, Minister of Health. “Increasing government’s share of the reimbursement cost – in some cases, even doubling it – will mean it will be more affordable for British Columbians to get these devices and enjoy their many health benefits.”

(BC Gov News 10/8/21)

CMS Innovation Center published whitepaper outlining strategy refresh

The Centers for Medicare and Medicaid Services (CMS) Innovation Center was established in 2010 as a part of the Affordable Care Act. The Innovation Center has launched and tested over 50 new care delivery models, all with the goal of furthering value-based care in Medicare, Medicaid and the Children’s Health Insurance Program. The Innovation Center’s new strategy will include a 5-fold focus: Drive Accountable Care, Advance Health Equity, Support Innovation, Address Affordability, Partner to Achieve System Transformation.

(CMS 10/21/21)

Virtual reality reimbursement challenges prevent reach to underserved patients

A research team from S.O.L.V.E Health Tech and AppliedVR examined how providers can reach underserved patients with innovations like virtual reality (VR). The team found that limited reimbursement caused a significant barrier to adoption. The researchers also highlighted the need for digital health companies to include marginalized and minoritized patients in product design and development. The majority of studies about VR have been conducted among primarily white, relatively advantaged populations in well-resourced settings.

(Fierce Healthcare 10/3/21)

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.