FDA Makes COVID Exemptions For Low-Risk Devices Permanent

 In News


Safer technologies program finalized by FDA

A newly finalized guidance from the FDA smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing treatment and diagnostic options for certain diseases and conditions. The Safer Technologies Program for Medical Devices (STeP) is intended for devices and combination products that target conditions that are less serious than those covered by FDA’s Breakthrough Devices Program, after which it is modeled. In addition to addressing less-serious disease and conditions – such as those that are treatable, or that will not lead to loss of life if untreated – devices qualifying for STeP should “significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations,” said FDA in the guidance.

RAPS- 05 January 2021

US FDA ramping up permanent 510(k) exemptions for dozens of low-risk medical devices

FDA has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification requirements, and has proposed similar exemptions for several other device types to expand access to these products during the COVID-19 public health emergency. According to a recent FDA notice, the seven Class I device types permanently exempt from 510(k) requirements include surgical and examination gloves; these exemptions took effect January 15, 2021. Types of devices targeted by the permanent 510(k) exemption proposal include a wide range of products and systems: home-use ventilators, airway monitoring systems, OTC electrocardiograph software, air purifiers and cleaners, medical device cleaners, N95 respirators and oxygenators.

EMERGO- 25 January 2021

US FDA unveils next steps for regulating artificial intelligence-based medical software

FDA has issued a new action plan laying out the agency’s planned approach to regulation of software as a medical device (SaMD) that utilizes artificial intelligence (AI) or machine learning (ML). The new action plan  builds on FDA’s proposed regulatory framework for AI/ML-based SaMD, published in April 2019, and subsequent stakeholder feedback. Managed by the FDA Center for Devices and Radiological Health’s (CDRH) Digital Health Center of Excellence, the action plan entails the same total product lifecycle regulatory approach the agency has espoused via its Software Precertification (Pre-Cert) program for oversight of other SaMD and digital healthcare technologies in recent years.

EMERGO- 15 January 2021

US FDA provides extra response time for device submissions on hold and expands virtual options

In June 2020, FDA published a guidance document outlining the impact of the COVID-19 pandemic on meetings and user fee applications for medical devices. The agency updated the guidance in December to extend compliance deadlines for medical device companies with applications and submissions on hold. In recognition of the challenge’s device makers face during the COVID-19 pandemic, FDA extended the deadline for companies to submit responses to the agency for marketing submissions and applications on hold before they are considered withdrawn.

EMERGO- 06 January 2021

Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning

OEHHA is proposing amendments that limit and revise the use of short-form warnings. Proposed changes include to (1) allow the short-form warning only (a) on products with 5 square inches or less of “label space” and (b) when the standard warning will not fit; (2) Prohibit the short-form warning for internet and catalog sales. This prohibition would apply even if the actual product label is eligible and contains the short-form warning; (3) Add a requirement that the name of at least one chemical per relevant toxicity endpoint be included in the short-form warning; and Include the words “Risk” and “Exposure” in the warning. Under the proposal, the new safe harbor warning for a product containing a potential carcinogen would read “ WARNING: Cancer Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”

(FDA Law Blog 1/20/21)



Clarifications to the 2021 Medicare remote patient monitoring requirements

The Centers for Medicare and Medicaid Services (CMS) released the 2021 physician fee schedule in December, prompting requests for clarification over new descriptions of remote patient monitoring. A CMS statement released in mid-January provides a more detailed explanation that the patient/clinician interaction requirement of 20-minutes per month can be met through interactive communication via a remote patient monitoring platform, as long as that is not the only type of interactive activity during the month.  CMS also stated that only one clinician can bill for remote monitoring of a patient during a month. This rule should be followed even when the patient is using multiple types of monitoring medical devices. If a more specific code is available to describe the monitoring service, such as continuous glucose monitoring, that code should be used instead of the generic remote patient monitoring codes.

(mHeath Intelligence 1/20/21)

Final MCIT Rule issued January 12th 

The Medicare Coverage of Innovating Technology (MCIT) rule establishes Medicare coverage of breakthrough medical devices for four-years following regulatory approval. The MCIT rule also codifies the definition of what constitutes “reasonable and necessary”. This phrase is used to describe the criteria for medical device coverage through Medicare. It is possible that the MCIT rule may be temporarily paused during the Biden administration transition, but substantive changes are not anticipated. A regulatory pause is typical during presidential administration changes.
(HealthPayer Intellegence 1/12/21)

ReWalk Robotics selling shares to raise funds for sales, marketing, and reimbursement expenses

The Massachusetts-based exoskeleton company seeks to raise $6.2M through sales of 5.6M ordinary shares. A part of the funds raised will be dedicated to pursing reimbursement through third-party payors. The ReWalk business model depends on the ability to sell exoskeletons for individual home use, which is predicated on adequate payment and coverage through health insurance.

(Mass Device 12/30/20)

New HCPCs codes issued for Trigeminal Nerve Stimulation

NeuroSigma, Inc. announced their successful application to CMS for new Healthcare Common Procedure Coding System (HCPCs) codes for their Monarch eTNS System. This system provides the first non-drug treatment of pediatric ADHD. The new HCPCs codes are K1016 (Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve) and K1017 (Monthly supplies for use of device coded at K1016). The codes can be used for medical billing starting in April 2021.

(NeuroSigma 1/22/21)


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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