Medtech firms assessing impact of proposed FDA regulation changes

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Local medtech companies are rushing to assess proposed new US Food and Drug Administration (FDA) rule changes that seek to have laboratory developed tests (LDTs) regulated as medical devices under the US Federal Food, Drug, and Cosmetic Act.The proposed changes are being aggressively opposed by numerous associations including the Coalition for 21st Century Medicine (C21) and the American Clinical Laboratory Association (ACLA).They say the latest FDA announcement is part of an ongoing process that has been evolving for more than a decade and has significant implications for the multi-billion dollar clinical testing industry.Looking to overcome Congress knock-backIn 2022, the VALID Act, which sought to establish a new framework for the FDA to regulate LDTs, did not pass Congress, and the FDA has now announced that it will seek to use the existing medical device framework to assess LDTs,The proposed rule would be phased in over a four-year period, after the changes are finalised.A 60- day comment period is expected to open imminently on the rule changes, however, the FDA has not provided a timeline on when it will make a final decision on the proposed changes.A coordinated response plan, including legal challenges, will be handled through coalition partners, professional associations and lobby groups that have been preparing for this announcement for several months.ASX-listed cancer specialist reviewing impactASX-listed cancer diagnostics companyPacific Edge ASX:PEBsaid the proposed changes, if finalised, would require it and other LDT providers to present evidence to the FDA that their tests are safe and effective for their intended use in addition to the current regulatory pathway of being accredited through clinical laboratory improvement amendments (CLIA).“The current system works well for patients and therefore any changes to the regulatory system must maintain that standard outcome. We will continue to work with our partners regarding regulation of our industry that is in the best interests of all stakeholders,” said chief executive officer Dr Peter Meintjes.“Notwithstanding this position, we have long recognised FDA’s intention to extend its oversight to include LDTs. Consequently, Pacific Edge has been working to prepare the company for this potential regulatory change to minimise any disruption to our US operations, including adopting good clinical ...

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