AdvaMed, Abbott ask FDA to prioritize cybersecurity, PCCP and LDT guidances next year

Abbott Laboratories and AdvaMed want the US Food and Drug Administration (FDA) to prioritize topics such as cybersecurity, laboratory-developed tests (LDTs), and predetermined change control plans (PCCPs) when developing guidances next year.

In October, the Center for Devices and Radiological Health (CDRH) published lists of guidances it plans to prioritize in 2025. In response, Abbott and the medtech lobby group AdvaMed wrote to the agency listing guidances they are especially keen on seeing advanced.

Both Abbott and AdvaMed listed guidances on medical device cybersecurity and LDT regulatory enforcement as top priorities.

The guidance entitled, Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls, is on CDRH’s A-list guidance for next year and would detail how the agency intends to regulate LDTs based on a rule finalized earlier this year. (RELATED: FDA issues long-awaited LDT final rule, Regulatory Focus 29 April 2024)

After attempting to regulate LDTs through guidance drafted in 2014, FDA walked back its effort following the November 2016 election, announcing at the time that it would not finalize its guidance on the matter. Afterwards, the agency pursued legislative action that would grant it explicit authority to regulate LDTs, namely through the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which ultimately failed to pass in Congress. In the absence of congressional action on the matter, FDA shifted its focus to rulemaking that would enshrine its authorities for such tests, though the agency’s final rule faces legal challenges that could unwind it.

Despite the possibility that the rule may be rescinded, AdvaMed wrote to FDA stating it wants the agency to prioritize the guidance to clarify the LDT rule.

"We support all efforts to clarify FDA expectations surrounding the FDA final rule regarding LDTs," said AdvaMed. "That being said, we are not aware of any draft version of this guidance; given the importance of the topic, it is imperative that this guidance first be issued as draft with opportunity for comment in advance of finalization."

Other guidances topping AdvaMed's priority list include guidances on medical device shortages and in vitro diagnostics during emergencies. The group is also interested in FDA revising guidances on requesting feedback from Q-submission meetings and using real-world evidence (RWE).

Abbott asked FDA to consider finalizing two draft guidances next year, including one on the use of PCCPs in medical device submissions and another on chemical analysis for biocompatibility assessments of medical devices. FDA's guidance on using PCCPs for artificial intelligence- (AI) enabled devices, which was finalized earlier this month, is already on the A-list but it does not have one on using PCCPs more broadly. (RELATED: Final FDA guidance on PCCP includes clarification on version control, Regulatory Focus, 3 December 2024)

AdvaMed also noted that several other guidances that it had expected to see were not on the FDA's priority lists.

"When considered as a whole, we note some notable omissions from these lists that we would have anticipated," said the group. "For instance, FDA issued three draft guidance documents related to the Accreditation Scheme for Conformity Assessment (ASCA) and a draft guidance regarding biocompatibility and chemical analysis."

AdvaMed listed more than 30 guidances it would like FDA to prioritize, revise, consider for development, or rescind. Abbott listed close to a dozen guidances it would like to see prioritized, some of which overlap with AdvaMed’s list.

Both pushed back against FDA’s decision to include revising a guidance on thermal effects of devices that produce tissue heating or cooling on its priorities lists. They argued that the issues raised by the agency should instead be addressed using standards.

“We do not support FDA proceeding with finalization of this draft guidance,” said AdvaMed. “As stated in our extensive comments to the draft guidance, we recommend that FDA withdraw this draft guidance and instead work with industry and other stakeholders to develop more targeted, device-specific policies. Ideally, this would be done via established consensus standards development processes.”

FDA 2025 guidance priorities lists

Comments on 2025 guidance priorities

AdvaMed, Abbott ask FDA to prioritize cybersecurity, PCCP and LDT guidances next year

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