While the medtech industry is overwhelmingly supportive of the move, several stakeholders have asked FDA for clarifications and more time in comments due to the Agency by 24 May 2022. They argue that the one-year transition period as proposed by FDA would be especially burdensome for smaller medtech manufacturers. “We believe that a 12-month effective date is too brief and instead offer a three-year effective date, which would give everyone ample time to transition, especially small US companies who have never operated under ISO 13485,” said the Medical Device Manufacturers Association (MDMA) in their comments to FDA. “The longer timeline also ensures that [outside the US] companies who are used to operating under ISO 13485 are not given preference over US companies who are new to the regulation,” they added. “Alternatively, we encourage FDA to implement a ‘phase in’ approach where the current version of the QSR remains effective for 3 years, the QMSR rule becomes effective relatively quickly, and companies may then choose to which version they want to comply.”
The Medical Imaging and Technology Alliance (MITA) also argued the transition phase proposed by FDA was not enough to allow companies who have never worked in the international standards time to come up to speed. “MITA recommends, however, there be a minimum two-year transition to ISO 13485 and that FDA provides clear guidelines on when the transition begins,” said MITA. “We believe the transition should not begin until all the affected guidance documents have been updated. The Agency should recognize it will be more challenging for smaller organizations not yet certified to ISO 13485, particularly if affected guidance documents have not been updated.”
In preparation for the transition, the group also asked FDA to continue internal training plans for inspection teams and develop educational resources for stakeholders including small and domestic manufacturers. Similarly, the medtech lobby group AdvaMed said that while it had recommended FDA allow a two-year transition period to adopt the new rule during a meeting of the Devices Good Manufacturing Practice Advisory Committee, it now is advocating for three years to make the transition. “After further reviewing the details of the proposed rule, and considering the remaining work needed from not just industry but also FDA before implementation, we recommend a three-year transition period,” the group said. “We would recommend that the three-year period start when all needed supporting documents, such as the updated inspectional model, and training are complete.”
AdvaMed said that FDA’s current QSR reference and certain terminologies are already embedded into hundreds of policies, procedures and documents, and updating those references will take a lot more time. “Despite the need for sufficient time, we are excited about the end-goal and suggest that FDA consider the possibility of allowing companies that are ready to begin implementing earlier,” AdvaMed added. “Such a transition approach would resemble the transition approach used for standards, where a company may use the new or prior version during the transition period.”
Besides asking for more time to transition to the new harmonized standards, medtech groups also asked for clarifications on numerous issues. For instance, MITA asked for clarification on how FDA plans to extend traceability of devices under ISO 13485 that are considered life-supporting or life-sustaining. They state that such devices are currently undefined by FDA.
“This scope extension presents a significant issue that would impact many manufacturers of medical imaging equipment, and those which incorporate off-the-shelf technology such as embedded PCs or standard commercial components,” the group said. “Imaging equipment used in conjunction with therapy might be directly impacted, such as image-guided ultrasound or other imaging used in surgical procedures. This traceability requirement may be difficult to address with many components that are used in such equipment, and yet the risks associated are very different from those of implantable devices.”
MITA also asked FDA to clarify that certification to ISO 13485 is not required to adhere to the new rule and how existing certification can be used by the medtech industry. They also asked for clarification on how the agency plans to conduct inspections under the new rule and whether its inspection processes will change especially in regard to issues such as Medical Device Reporting and labeling.
MDMA also said they have concerns with some of the definitions in the proposed rule such as the definition of the word “customer” which applies to stakeholders internal and external to an organization which they argue goes beyond requirements in ISO 14835. “We agree that everyone should be treated as a customer, however we view requiring documentation for ‘internal customers’ as an overly burdensome amount of paperwork that would result in very limited benefit,” they said.
MDMA also said its members have expressed concern that ISO 13485 was developed outside standard US rulemaking regulations that require the government to post a notice and collect comments. Further, they note that while companies should have full and free access to legal and regulatory requirements they are expected to follow, ISO 13485 is only available after purchase. “With respect to harmonizing the medical device manufacturer quality requirements in the United States to align with ISO 13485, FDA has proposed to incorporate ISO 13485 by reference,” MDMA notes. “Accordingly, in order to fully understand the contents of ISO 13485 as compared to 21 CFR part 820 for purposes of commenting on this proposed rule, companies have been forced to purchase access to ISO 13485. We request that FDA issue a new proposed rulemaking that contains the full text of ISO 13485, or make the full text of ISO 13485 publicly available without industry being required to pay for access.”
AdvaMed also used the QMSR rule as an opportunity to ask FDA to take actions against third-party servicers and refurbishers. The issue of servicing and remanufacturing has been a hot topic of late with medtech groups arguing that often such work endangers patients while right-to-repair advocates say stopping such work is a way for industry to prevent competition and continue to make money from users. “We also strongly urge FDA to reconsider its position of utilizing its discretionary enforcement powers vis-a-vis third-party servicers in light of the current geopolitical environment that is fraught with cybersecurity threats to our especially vulnerable healthcare sector,” AdvaMed said. “Given the current unregulated status of third-party servicing, the sheer number of third-party service entities, and the important role medical devices play in the nation’s medical infrastructure, it is not unreasonable to prepare for deliberate targeting of medical devices posed by unregulated third-party servicing entities.”
REFERENCE: RAPS; Regulatory Focus (News Articles 2022 5); 25 MAY 2022; Ferdous Al-Faruque