FDA Deregulates Certain Device Software Functions

 In News, Regulatory & Reimbursement Update


FDA issues final rule removing certain software from medical device regulations 

The US FDA has issued a final rulemaking that eliminates certain software intended to transfer, store or display clinical laboratory tests from being regulated as medical devices.  This action was taken to conform to the medical software provisions of the 21st Century Cures Act, enacted on 13 December 2016. The law amended the definition of a device in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to exclude such software; the law also removes software that encourages a healthy lifestyle from medical device regulations. The agency announced that with this final rule, FDA is amending the ‘identification’ description of eight classification regulations so that the regulations no longer include software functions that the Cures Act excluded from the device definition in the FD&C Act.

RAPS- April 19th, 2021

FDA walks back Trump-era premarket notification exemptions 

The US Food and Drug Administration (FDA) took steps to undo a sweeping deregulatory move that was pushed through by the Department of Health and Human Services (HHS) in the final days of the Trump administration. With less than a week left in the previous administration, HHS published a notice in the Federal Register exempting seven types of surgical and patient examination gloves and proposing to permanently exempt more than 80 Class II devices and one unclassified device from premarket notification requirements.

RAPS- April 15th, 2021

FDA authorizes labs for device conformity testing pilot 

FDA has cleared 53 testing laboratories to participate in its Accreditation Scheme for Conformity Assessment (ASCA) pilot, a voluntary program for medical device safety and performance testing. The ASCA-accredited laboratories will assess whether medical devices conform to consensus standards. FDA created the program to make conformity testing more consistent for device manufacturers undergoing 510(k) premarket notification and other regulatory reviews. So far, none of the laboratories, which include sites run by TÜV SÜD and UL, have received accreditation for biocompatibility testing. FDA plans to accredit more laboratories.

MEDTECHDIVE- April 14th, 2021

MDUFA V: Deficiency letters, staffing and funding emerge as issues in early negotiations

After a delayed start, the US FDA released minutes from the first two meetings held with the medical device industry to negotiation the terms of the next Medical Device User Fee Amendments (MDUFA V) program.

FDA pointed out that it met all its MDUFA IV review performance goals in FY2018 and has met the same goals for FY2019 and FY2020 for sufficiently complete cohorts where an outcome could be determined. Despite hitting its shared goal with industry on total time to decision (TTD) for premarket approvals and 510(k)s in FY2018, FDA suggests making changes in MDUFA V that could reduce the number of review cycles through improved submission quality. Instead of expanding the program, industry said its goals for MDUFA V are to “focus on fundamentals” and to establish an accurate baseline for the program.

Industry took aim at FDA’s staffing performance under MDUFA IV, citing 36 vacant MDUFA IV full-time equivalent (FTE) positions and that the number of FTEs involved in device reviews decreased from FY2018 to FY2019. The two sides also clashed over whether FDA met its MDUFA IV commitments related to digital health and deficiency letters. The two sides’ disagreements continued over to funding. FDA, seeking additional resources to expand the MDUFA program, pointed out that it collects nearly eight times as much fee revenue across its human drugs programs as it does under MDUFA. The device groups balked at the comparison, noting differences between the drug and device industries and market and suggesting that increasing fee revenue could increase the perception of regulatory capture.

(RAPS 4/20/2021)

ICH shares “work-in-progress” update to GCP guidance

The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group. ICH explained that the updates to the good clinical practice (GCP) guidelines are designed to align with the revised guideline on general considerations for clinical studies, ICH E8(R1). The latter guideline “includes a framework for designing quality into clinical trials, stakeholder engagement, trial design, proportionate trial management and focus on factors critical to the quality of trials.”

(RAPS 4/19/21)

AHIMA Launches mHealth Resource, Assessment Tool for Vendors

AHIMA has unveiled AHIMA dHealth. The site offers resources for healthcare providers on digital health products, including privacy and data security practices and policies, and an assessment tool designed to help vendors meet AHIMA standards. To become AHIMA-certified, a vendor will have to complete a self-reported assessment based on the organization’s standards and best practices for privacy and security. “Earning AHIMA dHealth Approval shows that your product takes privacy and data security seriously,” Wilson said in the release. “Having this designation allows developers to build trust with providers and patients, which has the potential to earn and positively impact more users.”

(mHealthIntelligence 4/30/21)


Medicare pricing leads to difficulties for long-term cardiac monitoring 

A regional Medicare contractor set low reimbursement rates for long-term Cardiac monitoring. The roughly $200 payment cut threatens the bottom line of companies such as iRhythm Technologies. The iRhythm Technology stock prices have plummeted nearly 40% in the wake of this news with the fear that Medicare will set the national reimbursement rate to match this new low regional payment. Other companies such as Preventice, Biotelemetry, and BardyDx are also impacted and as a result may withdraw from participation with Medicare.

(MedTech Dive 4/13/21)

CMS is encouraged to implement MCIT without further delay 

The Medicare Coverage of Innovative Technology (MCIT) rule was initially passed in January 2021, but was placed on hold during the change-over from the Trump to Biden administrations. The MCIT rule would provide coverage for devices that are designated as “Breakthrough” by the FDA. Medical device innovators applauded this legislation and AdvaMed provided input on the MCIT delay during the public comment period, urging Medicare to pass the policy as it was originally written.

(MedTechDive 4/19/21)

Value-based payment models are becoming more widely accepted for drugs and medical devices 

Panelists at the MedCity News INVEST conference shared insights into value-based agreements that are shaking up the traditional process of insurance coverage negotiations. Value-based contacts tie the cost of the treatment to the patient’s outcomes. In order to reach these agreements, both parties must decide on the outcomes of interest and the assigned value. This differs from traditional fee for service arrangements, where the payments are made based on the number of treatments provided, not the outcome of those treatments. Value-based agreements are an ongoing effort and the complexity of the process has contributed to the slow adoption of this model.

(MedCity News 4/22/21)

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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