By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)

It’s tough to make predictions, especially about the future.” Whether baseball Hall of Famer-slash-philosopher Yogi Berra actually said these words or not, the sentiment rings true, as anyone who has tried to predict the course of the COVID-19 pandemic would know. Predicting when the Center for Devices and Radiological Health (CDRH) at the U.S. Food & Drug Administration (FDA) will return back to normal is also no exception. Just as things were starting to look up, the Omicron coronavirus variant has appeared to put another wrench in FDA’s plans. This has delayed FDA’s in-person return to the office and caused FDA to postpone non-mission critical inspections until February 2022.[1] While FDA’s COVID-19 response is still the Agency’s number one priority, there are other important changes to be aware of in 2022.

MDUFA V Negotiations

FDA is actively planning for their premarket review programs in 2023 and beyond. Throughout 2021, FDA held a series of meetings with industry representatives and other stakeholder groups like patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts. The purpose of these meetings was to discuss the parties’ views on the reauthorization of the Fiscal Years 2023 to 2027 Medical Device User Fee Amendments (MDUFA V), which allow FDA to collect user fees to fund their medical device premarket review processes. Meeting minutes were posted publicly for meetings held in the first half of 2021, and they provide insight to the various goals of FDA and different stakeholders groups in the negotiation process.

At a meeting held on June 16, 2021, FDA presented top areas of feedback from stakeholders, which focused on device safety, digital health, real-world evidence (RWE), and patient science and engagement.[2] However, there does appear to be a major point of contention between what FDA and Industry are proposing.

FDA Proposal: TPLC Advisory Committee (TAP)

Regarding the proposal to include more stakeholders early in the product lifecycle, the FDA-Industry meeting minutes from April 28, 2021 reflected ongoing tension between the FDA and industry regarding a proposed TPLC Advisory Committee, or TAP. Citing declining investment and startup activity in the MedTech sector, FDA argued that it and industry must do more to ensure that U.S. patients have greater access to safe, effective, high-quality innovative medical devices first in the world. From FDA’s perspective, the current MDUFA program only optimizes a limited portion of the product lifecycle.

On top of that, industry’s interest in interactive review before a filing has led to a significant increase in Pre-Submissions, to the point where FDA received more than double the number of Pre-Submissions than were funded by MDUFA IV. The TAP is intended to address these challenges by providing submission sponsors with earlier, more frequent, and more strategic communication not just with the FDA but also with external stakeholders like payors and physician professional societies. FDA proposed to use the TAP for devices that are eligible for the Breakthrough Devices Program and the Safer Technologies Program (STeP) as well as other devices with public health importance.

The initial TAP proposal, however, was not well-received by industry, as they thought it may go beyond the scope of FDA’s traditional premarket review role. They questioned the need for a new program in lieu of continued targeted improvements to the premarket review process and expressed concern about the willingness of stakeholders like private payors to provide early strategic advice. Industry explained that they are not focused solely on the speed of FDA review but also on the transparency, consistency, and predictability of the review process. Industry’s concern in that sense was that the interaction between the TAP and review teams could introduce another layer of unpredictability, and they argued that the current FDA programs with MDUFA-funded employees hired could provide the necessary early interaction and efficient review. This is aligned with other comments regarding MDUFA funding, with Industry arguing that MDUFA fees should only be used for premarket reviews and not for other programs (e.g., Postmarket activities).

Industry’s Proposal: “Back to Basics”

The most recently posted meeting minutes are from the FDA-Industry meeting held on June 30, 2021, and they reflected one of the main themes of the ongoing negotiations: FDA staffing resources. FDA described the financial operation of the MDUFA program and explained challenges related to recruitment and retention of staff. Both FDA and industry sought to ensure MDUFA V funding would allow for efficient, timely, and thorough review of submissions to meet timeline commitments.[3]

In line with their feedback regarding the TAP, industry’s perspective throughout the meetings was that MDUFA V should reflect a “back to basics” approach. The proposed “back to basics” model included meeting existing MDUFA IV commitments as well as suggested premarket review changes like improvements to existing review processes and reinvesting carryover MDUFA funds into “areas of mutual agreement to enhance the premarket review program.” Industry also expressed interest in addressing the FDA workload backlog and accountability for resource and staffing targets. In particular, they proposed a “full accounting and quarterly reporting” of hires and vacancies in previous MDUFA rounds, as well as annual hiring targets for MDUFA V to meet the desired review speed and efficiency. They further proposed a third-party, independent audit of how MDUFA funds are used.

In response, FDA has proposed a plan for a "capacity adjustor" to address the risk that unanticipated, sustained increases in MDUFA workload could negatively affect their ability to meet performance commitments. The capacity adjustor would be a mechanism to evaluate a pilot and translate a percentage workload change to resourcing needs. [4]

Although no meeting minutes are publicly available for any meetings held after June 30, it appears that the FDA and industry may still be far apart on their proposals, as they recently missed a January 15, 2022 deadline to send a MDUFA V user fee agreement to Congress. With the current MDUFA IV user fee program set to expire on September 30, there may be a rush to complete negotiations over the next few months.

CDRH Guidance Document Priorities for 2022

In October, CDRH published lists of their proposed Guidance priorities for the 2022 fiscal year.[5]These include a priority “A-list” of Guidance Documents that they intend to publish this year as well as a smaller “B-list” that they intend to publish as resources permit. Their proposal also includes a list of previously-issued final Guidance Documents for which CDRH is interested in receiving external feedback to determine whether the Guidance should be revised or withdrawn.

What is on CDRH’s A-list?

Published a year after launching the Digital Health Center of Excellence, the CDRH list of guidance priorities reflects their continued ambition to advance the regulation of digital health technologies. Medical device software continues to be among the top priorities for CDRH guidance in 2022, beginning with a final Guidance for clinical decision support software. The A-list also includes plans to issue new draft Guidance Documents related to computer software assurance for production and quality system software, medical device cybersecurity, and premarket submissions for software as a medical device (SaMD) and software in a medical device (SiMD).

Although they appear on the lower-priority “B-list,” CDRH intends to issue draft Guidance related to artificial intelligence/machine learning (AI/ML)-enabled device software and risk categorization for SaMD. Finally, CDRH indicated that they are seeking feedback to determine whether the 2002 guidance document “General Principles of Software Validation: Guidance for Industry and FDA Staff” should be revised or withdrawn.

Additionally, it should be no surprise that COVID-19 guidance remains a high priority for CDRH. They have already issued two Draft Guidance Documents related to transition plans for enforcement policies and Emergency Use Authorizations (EUAs) issued during the pandemic (check back in February for what you need to know about EUA devices and enforcement policies in the coming year!) The voluntary improvement program and voluntary malfunction summary reporting (VMSR) program are also priority topics for CDRH as they seek to promote regulatory compliance for the benefit of medical device safety and effectiveness.

Among other A-list topics is a plan to issue final guidance regarding the new eSTAR electronic submission template for Premarket Notification 510(k) submissions. As described in the draft guidance, the content and format of the new eSTAR template is intended to reflect the internal templates used by FDA reviewers to review submissions, which may eliminate the need for a full refuse-to-accept (RTA) review and help facilitate more efficient 510(k) reviews. It is also important to note that the eSTAR template is now available for De Novo Classification Requests.[6]

Other topics on the A-list include plans to finalize Guidance Documents for post-market data collection requirements, like the Guidance on “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act” and “Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order.” CDRH also intends to finalize guidance about remanufacturing of medical devices and UDI policy, and they will issue new draft Guidance Documents regarding premarket submissions targeting opioid use disorder as well as select updates to the Breakthrough Devices Program.

Quality System Regulations

The harmonization with global quality system requirements appears to have made some movement in that the proposed rule was sent to the Office of Management and Budget on January 5, 2022[7]. Once this step is complete, we can expect to see it published in the Federal Register.

In case you missed it, our experts recently shared their insights to how FDA did in 2021 and provided a recap of the most important, cross-cutting regulatory changes as well as a forecast of what to expect in 2022 on RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA Submissions. Watch the on demand recording here.

Need more support? Discover how our team can provide regulatory support for every clinical specialty and device class. Contact us today.

Sources:

[1] FDA Roundup: January 4, 2022 (2022, January 4). Retrieved from U.S. Food and & Drug Administration: https://www.fda.gov/news-events/press-announcements/fda-roundup-january-4-2022

[2] FDA-Industry MDUFA V Reauthorization Meeting, June 16, 2021. (2021, June 16). Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/media/154645/download

[3] FDA-Industry MDUFA V Reauthorization Meeting, June 30, 2021. (2021, June 30). Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/media/154644/download

[4] FDA-Industry MDUFA V Reauthorization Meeting, May 19, 2021. (2021, May 19). Retrieved from U.S. Food & Drug Adminstration: https://www.fda.gov/media/154643/download

[5] CDRH Proposed Guidances for Fiscal Year 2022 (FY2022). (2021, October 26). Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidances-fiscal-year-2022-fy2022

[6] Voluntary eSTAR Program (2022, January 03). Retrieved from U.S. Food & Drug Administration. Retrieved from: https://www.fda.gov/medical-devices/premarket-notification-510k/voluntary-estar-program

[7] Pending EO 12866 Regulatory Review (2022, January 5). Retrieved from Office of Information and Regulatory Affairs: https://www.reginfo.gov/public/do/eoDetails?rrid=212912

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