Medical Device Recalls Up in First Half of 2021 and Draft Cures 2.0 Bill Seeks Breakthrough Coverage
Medical device recalls were way up in 2019 with a total of 49 recalls at year end, but at this point in the year, 2021 is on track to beat that at 29 recalls mid-year. While the majority of recalls FDA has classified this year have not been associated with any patient injuries or deaths, nearly a dozen of them have. Among these include Medtronic’s HeartWare system and Valiant Stent Graft System, and Boston Scientific’s Subcutaneous Electrode.
(MDDI Online 6/30/21)
Under the Biden administration’s first regulatory agenda, the US Food and Drug Administration (FDA) is preparing to promulgate three dozen proposed and final rules related to human drugs, biologics, medical devices and clinical trials. Many of the rules are holdovers from previous biannual agendas, such as a final rule on the de novo classification process for medical devices and a proposed rule on modernizing the quality system regulation to harmonize with the international standard, ISO 13485:2016. Both rules, as well as proposed rules related to the classification of over-the-counter hearing aids and the classification of spinal spheres for use in intervertebral fusion procedures, were slated for publication this June, according to the latest agenda.
The latest FDA – Industry MDUFA V Reauthorization Meeting centered mainly around FDA and industry’s disparate goals for MDUFA V. The tension was between FDA’s focus on a proposed Total Product Life Cycle (TPLC) Advisory Program and industry’s preference to go “back to basics” and ensure existing commitments under MDUFA IV are being met. While industry seems satisfied with the current MDUFA program, FDA said in October they are “seeing signs of strain” due to the COVID-19 pandemic and the agency indicated current MDUFA performance is not sustainable.
FDA outlined a proposal for a TPLC Advisory Program where “early, frequent, and strategic communications between FDA and sponsors could yield more rapid patient access to safe, effective, and innovative medical devices.” Industry questioned the need for a program like TAP, referring to their request to go “back to basics” and noted that current FDA programs “can provide the necessary early interaction and efficient review.” Further, industry said FDA’s initial targeting of programs under a proposed TAP initiative may not yield devices that “would justify the creation of a new program.”
A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall. The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) in announcing its availability. The guidance is intended to clarify, rather than to change, the regulatory requirements to which remanufacturers must adhere. “It is not intended to adopt significant policy changes,” according to CDRH.
(RAPS- 17 June 2021)
FDA has warned the Biden administration that recent ransomware attacks on hospitals and health systems “highlight the ungraceful failure” of perimeter-based firewalls and the safety consequences of not separating operational technology (OT) from information technology (IT). FDA’s document provides its current OT cybersecurity practices and efforts while laying out its support for NIST’s goal of developing software-related standards and guidelines especially for a Software Bill of Materials, an electronically readable format designed to provide an inventory of third-party components in devices. The agency contends that SBOMs, which were called out in Biden’s order, are essential to securing the software supply chain and are critical to managing safety risks to patients.
(MEDTECHDIVE- 9 June 2021)
The newly released Cures 2.0 bill draft includes the Ensuring Patient Access to Critical Breakthrough Products Act, which seeks to codify the Medicare coverage of innovative technology guidelines and require an exploration of alternative coverage pathways. The draft legislation contains language similar to the recently-delayed MCIT bill and states that transitional coverage for breakthrough devices would begin on the day of FDA approval and would require evidence to support regular coverage within one year.
(MedTech Dive 6/24/21)
The 127-page Cures 2.0 bill discussion draft was released in late June. In reaction to the healthcare changes surrounding the COVID19 crisis, the bill includes provisions to extend telehealth coverage. Specifically, the bill contains the Telehealth Improvements for Kids Essential Services (TIKES) Act, the Telehealth Modernization Act.
The Office of the Inspector General issued a report in June with findings that Medicare does not have consistent oversight of the cybersecurity controls of networked hospital medical devices. This lack of control may lead to potential patient harm. Ransomware attacks on hospitals have increased sharply over the last year. Such an attack may provide access to patients’ health records and other sensitive data. Medicare accreditation organizations could use their authority to assess cybersecurity as a part of the quality oversight process, but few use their discretion to hold hospitals to account on this aspect.
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.