Q1 Medical Device Recalls Linked to Unprecedented Level of Faulty Manufacturing and CMS announces Transitional Coverage for Emerging Technologies

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Regulatory and Reimbursement

Medical Device Recalls Linked to Unprecedented Level of Faulty Manufacturing

According to the most recent “U.S. Product Safety And Recall Index” report by Sedgwick, manufacturing defects are the leading cause for product recalls in 2023 through the month of March. Several manufacturing defects were related to an inability to guarantee product performance when recommended temperatures and time out of range were exceeded. These findings reportedly mark the first time in the 12-year history of the report that device recalls were blamed on manufacturing defects. Typically, issues such as sterility, quality, or malfunctioning parts are cited as the leading causes of product recalls. The report also found that medical device recall events increased by nearly 5% during the first quarter of 2023 compared with the last quarter of 2022, and the total number of impacted device units among the recalls has jumped more than 34%, up to 83.3 million. Among the overall medical device recalls during the first quarter of 2023, more than 75% — 45 total incidents — were reported by one unnamed company,

(MDDI Online 6/26/23)

Minor Updates to FDA Pre-Submission Guidance With More to Come

On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry. Traditionally, pre-submission meetings have occurred 60 – 75 days from FDA receipt of submission. Now FDA says that “[m]eeting dates between 70 – 75 … days are most likely to be feasible.” In the revised Pre-Submission Guidance, FDA “highly recommends” submitting a pre-submission to obtain feedback on a PCCP, if a sponsor is considering including one in a future pre-market submission. By March 31, 2024, the FDA will issue a new, draft guidance which will include information to assist applicants and review staff in identifying circumstances in which informal communication is more appropriate than a pre-sub for an applicant’s question.

(FDA Law Blog 6/20/23)

The MDR Deadline Extension: Use the Time Wisely

European health ministers have seen a regulatory “perfect storm” on the horizon since MDR took effect in May 202. The number of certified NBs in Europe decreased from 125 before MDR to around 20 after its implementation. That number has increased to 38 (as of April 2023) but is still only a fraction of what is needed to help manufacturers take this crucial regulatory step. Complicating matters, the number of device applications these bodies have received is overwhelming. By October 2022, NBs had received 8,120 applications and certified 1,990 under MDR—and they will continue to receive new applications right up to the May 26, 2024 deadline. A survey of NBs estimated that, at the current pace, as many as 7,000 devices could be certified by the original MDR compliance deadline, which clearly would not have eliminated the backlog. Team-NB is a European trade group aimed at pursuing transparency for NBs and providing guidance around MDR implementation. In an April 2023 statement, Team-NB estimated that the 38 designated NBs currently operating in Europe could issue 3,200 MDR certificates annually. The group also noted that the number of NBs may increase and the efficiency with which certificates can be issued may also improve—both factors that would speed up MDR certification. Team-NB concluded by saying the latest MDR deadline extension (Amendment EU 2023/607) makes certifying all remaining devices achievable as long as manufacturers do not delay their applications.

(MedTech Intelligence 6/27/23)

Managing Software Vulnerabilities: How to Utilize ISA/IEC 62443 and Software Bills of Materials

In response to executive order 14028, Improving the Nation’s Cybersecurity, the FDA’s Refuse to Accept Policy (RTA) states that applications for medical devices filed after October 1, 2023, that qualify as cyber devices will be subject to a new process that gives the FDA the ability to issue RTA decisions based on cybersecurity-related elements of the submission filing. Organizations who utilize SBOMs may have a leg up when it comes to the RTA policy. The FDA’s new recommendations clearly call for a supply chain vulnerability management process and the capability to ingest, generate, maintain, and distribute SBOMs. The ISA/IEC 62443 series of standards, which define requirements, processes, and best practices for designing, implementing, and maintaining secure systems, enable the production and consumption of SBOMs at various points in the supply chain, starting with the product supplier (e.g., software component supplier), then manufacturers (e.g. medical device manufacturer) and finally by the asset owner (e.g. healthcare delivery organization). Adoption of both SBOMs and the ISA/IEC 62443 series of standards can help ensure that medical devices not only breeze through FDA’s premarket submission process but also can be operated safely and securely by end users throughout their service life.

(MedTEch Intelligence 6/25/23)

PFAS: Medtech Restrictions and Impacts

When devices are evaluated for their safety during use, they are tested for their biocompatibility, and oftentimes due to short contact duration a detailed chemical analysis is not performed; as risks for any chemical, including PFAS, to leach out of a device and be exposed to the patient depends on the duration of contact. Understanding that the allowable limit of perfluorooctanoic acid (PFOA) (one of the six PFAS under regulation) is set at 4 ng/L in drinking water, manufacturers are wondering if the drinking water limit can be applied to a medical device with PFAS coating. For medical device manufacturers that do not use PTFE or other PFAS-containing chemicals in their processes, this movement may only mean an additional so-called “pen-and-paper” approach that clarifies that these substances are not used in their devices. However, if PFAS are present, additional justification for their necessity, including superiority to alternative chemicals may be on the horizon.

MDDI Online 6/21/23

CMS announces TCET 

The Centers for Medicare & Medicaid Services (CMS) has proposed a new program called Transitional Coverage for Emerging Technologies (TCET) to expedite Medicare coverage for breakthrough medical devices. The voluntary program aims to offer three to five years of transitional coverage and is intended to support improved patient care and innovation while maintaining safeguards for the Medicare population. The TCET pathway will be available for FDA-designated breakthrough devices within a Medicare benefit category that are not already covered by an existing Medicare national coverage determination and not excluded from coverage by law or regulation. The program includes evidence previews and evidence development plans to address evidence gaps, and it allows device manufacturers to engage with CMS and utilize fit-for-purpose studies to support Medicare coverage. The CMS is seeking public comment on the proposal, and manufacturers can express their interest in the program by emailing CMS. Coverage under TCET will last as long as necessary to generate evidence and inform decision-making, typically lasting three to five years, with additional coverage for analysis, reporting, and publication. CMS intends to finalize TCET National Coverage Determinations within six months of FDA market authorization.

(Medical Device Outsourcing 6/23/23)

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 Director, Quality and Regulatory, and Angela Smalley, PhD, Simbex Senior Product Consultant.  A story’s inclusion does not imply endorsement by Simbex.

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