Regulatory

MDUFA V: US FDA sets performance goals for De Novo medical device reviews

MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 through 2027. The FDA’s objective in reviewing performance goals is to promote more timely access to safe and effective medical devices. Toward this end, the agency will report the average Total Time to Decision following each closed fiscal year-end. For FY 2023, the average Total Time to Decision Goal is 128 days with the goal to reach 112 days by 2025. The decision goal under MDUFA V is for the FDA to complete a review within 150 calendar days for 70% of De Novo submissions.

(Emergo 3/21/22)

MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal it has struck with the medtech industry. “MDUFA V will provide for FDA to decrease registration fees if the agency has more than 13 weeks of operating reserves in the carryover balance,” the commitment letter states. “In addition, during MDUFA V FDA will use funds in the carryover balance to support the Third Party Review program and the Total Product Life Cycle Advisory Program Pilot.” It also states that at least once a year, the FDA and industry will negotiate on how to best use carryover funds to improve device application reviews. As in previous MDUFA agreements, the commitment letter also includes provisions to hire independent third-party auditors to evaluate how well FDA is sticking to the provisions of the user fee deal. Under the new commitment letter FDA will be required to either finalize a draft guidance within five years or withdraw it.

(RAPS 3/23/22)

MDO analysis: FDA medical device recalls drop to lowest levels since 2013

Device products recalled in fiscal year 2021 (ended Sept. 30) totaled 2,607, a 14.3% drop from the 3,042 recalls reported in fiscal 2020. The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols. In fiscal 2021, Class I recalls dipped 1.2% to 169, Class II recalls decreased 15% to 2,389 and Class III recalls dropped 19.7% to 49.

(Medical Design Outsourcing 3/4/22)

FDA final guidance presses industry to be ‘recall ready’

FDA has finalized guidance on the preparations companies should take to ensure they quickly and effectively execute voluntary product recalls. The agency wants all companies in the supply chain to be “recall ready” with the steps they should take, before it becomes necessary, including developing policies and procedures. While the FDA has the authority to require recalls of certain products in particular circumstances, Associate Commissioner of Regulatory Affairs Judith McMeekin in a statement said voluntary recalls “continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market.” The agency recommended companies use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall.

(MEDTECHDIVE: March 4^th, 2022)

Stakeholders want more clarity about devices used for remote clinical studies

In December, the agency published its draft guidance titled, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” which is especially timely as researchers are trying to continue their clinical studies during the ongoing COVID-19 pandemic. In the guidance, the agency outlines what kinds of devices and software may be used for remote monitoring of clinical trial participants in order to ensure the data is sufficient for a product application. Several companies, individuals, and organizations have written to the FDA asking for further clarifications as well as suggestions on how to expand the guidance to help clinical studies be more successful. One company is asking the FDA to expand its definition of DHT beyond computing platforms, connectivity products, software, and sensors to also include monitoring devices. The company also argues, the guidance should take into consideration that clinical trial patients may use their own devices, so-called Bring Your Own Devices (BYOD). Another company said the definition of DHT is too broad. The organization recommended the FDA include definitions of what products are not considered DHT as well as those that are.

(RAPS 24 March 2022)

Payment

The Digital Therapeutic Alliance says CMS is prioritizing heart valves over brain health

The Centers for Medicare and Medicaid Services (CMS) has recently rescinded Medicare Coverage of Innovative Technologies (MCIT), which would have provided Medicare coverage for breakthrough medical devices. A proposed replacement version of MCIT, called Transitional Coverage for Emerging Technologies (TCET), is currently under review. The Digital Therapeutics Alliance is concerned about disparities in coverage for medical technology that address brain health. Their analysis of the 325 designated breakthrough devices found that digital therapeutics for brain health or behavioral health conditions are much less likely to be reimbursed when compared to breakthrough devices for cardiology.

(Digital Therapeutics Alliance 3/28/22)

Lancet Viewpoint article outlines priorities for advancing digital health applications

This Viewpoint provides highlighted findings from a roundtable of the Digital Medicine Society and Health Innovation Hub of the German Federal Ministry of health. One important conclusion is the need to clarify evidence standards for coverage versus regulatory approval. Health technology assessments should be more dynamic for digital products. Health care systems should be open to the concept of flexible reimbursement based on ongoing assessment of the digital product’s performance using real world evidence. Readers of scientific publications should expect to encounter more real world data as it becomes increasingly important to the digital health ecosystem.

(Lancet Digital Health 3/1/22)

Report designates Germany, Belgium, and France as Europe’s digital health “trailblazers”

A report by Research2Guidance (R2G) categorizes European countries by their adoption of digital health technologies as characterized by their public health insurance reimbursement status.  Leading the way is Germany with their Digital Health Applications (DiGA) Fast Track process, which is a pathway that allows apps to be prescribed by doctors and covered by insurance. There are almost 30 approved apps at this time. France and Belgium made recent announcements of intent to launch a similar scheme for apps that are CE-marked as medical devices.

(MobiHealthNews 2/18/22)

Myomo continues to work on reimbursement 

In a recent earnings call, Myomo CEO, Paul Gudonis, noted some difficulty with one of their larger commercial payors, who was denying claims on the basis of the MyoPro device being considered “experimental and investigational”. This issue is requiring an additional appeal process after device delivery.  This hurdle is offset by the addition of several new payors including Medicare Advantage plans, commercial plans and several state Medicaid plans. Myomo has also had some success with coverage in Germany and international sales represent approximately 10% of the annual revenue.

(Seeking Alpha, 3/9/22)

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, Quality Systems Coordinator.  A story’s inclusion does not imply endorsement by Simbex.