Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments." If finalized, the proposed rule will rename the current 21 CFR Part 820 as the Quality Management System Regulation (QMSR). In our previous post, we noted both the industry representatives and the Committee welcomed the proposed rule but agreed that it may have an overly ambitious implementation timeline, especially in light of the ambiguity in some key areas, such as inspection. These concerns were echoed by FDA, which acknowledged the need to engage in a variety of implementation activities including personnel training, inspection approach finalization, and revising relevant regulations and other documents impacted by the rule. Below we discuss some of the major concerns raised by both industry representatives and the Committee during the meeting.
- A one-year transition period would not give the industry sufficient time to be fully compliant with the new requirements. QMSR proposes a one-year transition time after the final rule goes into effect. Representatives from both the Advanced Medical Technology Association (“AdvaMed”) and the Medical Imaging and Technology Alliance (MITA) raised concerns about the short implementation timeline. Jamie Wolszon, Vice President of Technology and Regulatory Affairs at AdvaMed, stressed that “there must be a sufficiently long transition period to avoid disruption. We recommend at least a two-year transition period.” She emphasized that the one-year transition period proposed by FDA would not give the industry enough time to adapt to the new requirements. The Committee concurred with the industry’s concern that a one-year transition period would be “quite aggressive,” and a two- or three-year transition period would be more appropriate.
Moreover, Committee members reminded FDA that the agency will also need a significant amount of transition time once the proposed rule is finalized. Robert Phillips of Siemens Healthineers, who serves on the Committee, noted that a significant number of FDA guidance documents will all need to be updated to align with the new regulatory citations, definitions, and systems. He further noted that these updates need to be worked out and made publicly available before a transition can be effected by device firms. Committee members reminded the agency that when the current Quality System Inspection Technique (QSIT) was launched, it took two to three years for auditors to fully understand and work with QSIT.
- Industry representatives demand more clarity on the future inspectional approach. The agency proposes to replace the current inspection approach for medical devices, the QSIT, with a new inspection model and manual to be determined and announced by FDA. This regulatory vacuum will leave companies with no guidance on how to prepare for future inspections. For example, it is unclear whether inspection programs under the current QSR, such as pre-approval, surveillance, and for-cause inspections, will survive. Diane Wurzburger, Executive of Regulatory Affairs for GE Healthcare, speaking on behalf of MITA, also asked whether FDA’s process to inspect other requirements (e.g., medical device reporting and labeling) will change. The industry also urged FDA to harmonize not only regulatory expectations, but also the actual procedures for inspections. Specifically, the industry wants to avoid a “13485 plus type of approach,” where there could be “additional requirements over and above 13485 that are country-unique.” These concerns were widely echoed across the industry.
- The industry demands clarity on whether ISO 13485 certification will be required. Despite incorporating the ISO 13485 standard, FDA has stated that its inspections “will not result in certificates of conformance to ISO 13485 and manufacturers who have ISO 13485 certificates are not exempt from FDA inspections.” However, the proposed rule did not clarify whether an ISO 13485 certificate will be required or expected. Committee member Phillips of Siemens Healthineers noted that “topics about whether certification is required, or even expected … [are] something that needs to be clarified going forward.” This regulatory uncertainty is particularly relevant for small firms that need to determine whether to apply for formal certification from an accredited auditing body. Further, even if not explicitly required, questions remain about whether there will be preferential regulatory treatment for companies that are formally certified, which could put smaller firms without international presence at an unfair disadvantage. AdvaMed’s Jamie Wolszon emphasized that the industry is interested in understanding how FDA intends to leverage existing ISO 13485 certifications, including whether there will be any “potential benefit(s)” for firms that are certified.
- Risk management represents a significant change for small companies not previously subject to the ISO 13485 standard. Harmonizing FDA regulations with the ISO 13485 standard means implementing risk management processes throughout the total product life-cycle. Although FDA denies that the harmonization amounts to a policy shift, Melissa Torres, Associate Director for International Affairs at the Center for Devices and Radiological Health (CDRH), acknowledged during the meeting that compared to the current Part 820, ISO 13485 “has greater integration of risk management activities and stronger ties to ISO 14971, the risk management standard for medical devices.” Committee member Scott Sardeson pointed out that the proposed change represents “a very big shift in mindset” for smaller companies that are not currently subject to the ISO 13485 standard and may not be aware of uncodified expectations from FDA. These concerns add to the case for a longer transition period.
The proposed rule may have a significant impact on device manufacturers, especially those not in compliance with the current ISO 13485 standard. If the one-year proposed implementation timeline is not changed, device manufacturers will face a tight schedule to be in compliance with the new rule. It is highly recommended that all device manufacturers, especially those without an international presence, review the proposed rule and identify any possible issues with compliance in order to address their challenges head-on.
Comments on the proposed rule can be submitted in the Federal Register (Docket No. FDA-2021-N-0507) until May 24, 2022.