FEATURE
Stage one requirements focus on medical device reporting , quality management systems , and correction and removal reporting requirements . “ The good news is that we already have that structure in our laboratory ,” Levinson said . “ We ’ re going to lean on our quality assurance team and structures like our document control system and build them out to take us to that May 2025 deadline .”
Public health laboratories are also working together to help ensure readiness to meet the rule ’ s phased requirements . Lange said her laboratory is maintaining a catalog of resources , including what other states are doing .
Levinson encouraged colleagues to make use of all available tools . “ FDA has provided a lot of information ,” she said . “ The LDT Task Force at APHL has made sure tools and resources are there to help laboratories understand what this rule is , how it will affect them , and what they need to do to comply . If you don ’ t have strong infrastructure in place , there are tools to help you .”
According to Levinson , Southeast ColLABborators have been talking about ways they can lean on each other , including potentially regionalizing some testing . “ Maybe we don ’ t all have to reinvent the wheel ,” she said . “ Regionalized testing may help us meet those needs at a scale that ’ s a bit bigger than our individual jurisdictions .”
Yet Levinson noted that public health laboratories may face more significant preparatory challenges as deadlines for subsequent stages of the FDA rule approach .
“ Requirements are going to get further and further from the processes we have in place and require more system and process building ,” she said . “ That ’ s going to take time and staff that we haven ’ t currently allocated for . My level of concern goes up as I look toward subsequent rollout of various phases . But we have time , and we ’ ll meet those deadlines as they come .”
The new LDT rule represents a “ paradigm shift ” in how public health laboratories approach regulation of their tests , according to Levinson . “ It ’ s a big change ,” she said . “ At the end of the day , we all want the same thing — accurate and timely tests that meet the needs of our patients and our populations . I think that ’ s at the heart of the FDA ’ s goals and of all our federal partners . We all want the same thing . It ’ s a matter of coming to agreement on how we get there . This rule is in effect and the silver lining is it ’ s an opportunity to look at our current system for quality and make it more robust .” g
Tools and Support for Public Health Laboratories
APHL has assembled the LDT Task Force , a core team of APHL member quality and subject matter experts , to interpret and communicate the requirements of the FDA final rule , according to Mandi Cosser , MPH , manager , regulatory and public policy for APHL .
“ As we look at these stage-one requirements , laboratorians are understanding that this is good laboratory science ,” she said . “ Clarification and additional information are needed on how we implement record-keeping correction and removal reporting . APHL is working on a guide to meeting stage-one requirements .”
Cosser said APHL will continue to support members with information and tools as a consolidated lawsuit against FDA by the American Clinical Laboratory Association and the Association for Molecular Pathology unfolds .
There is also some uncertainty around the rule ’ s future with a new administration , according to Cosser . “ We ’ ll continue to update members every time we learn more information ,” she said . “ Until then , we ’ re here to support members as they keep moving forward .”
APHL has created several resources to assist members with complying with the FDA final rule :
• A Laboratory Developed Test Regulation webpage with information , history and guidance , as well as links to FDA resources and other resources
• Email updates to members on actions taken
Members who have questions about the FDA final rule on LDTs should email LDTquestions @ aphl . org .
14 LAB MATTERS Spring 2025
PublicHealthLabs @ APHL . org APHL . org