POLICY
population , specimen type and testing volume needs . APHL communicated this information via public comment to the FDA in December 2023 and was pleased to see many of the suggestions reflected in the Final Rule . Of significant importance to public health laboratories is the targeted enforcement discretion for certain types of tests , an improvement from the restrictive Proposed Rule language and a benefit to public health .
FDA will give targeted enforcement discretion with respect to premarket review requirements for LDTs implemented before May 6 , 2024 . This means the LDTs public health laboratories had in use by that date will not be subjected to the full FDA review process ( also known as a premarket submission , which includes 510 ( k ) and De Novo packages ) if they are not modified or are modified in limited ways . Additionally , FDA has acknowledged that modifications to FDA-authorized tests are sometimes needed , such as to add specimen types . Under the Final Rule , there will be targeted enforcement discretion for limited modifications to another manufacturer ’ s FDA-authorized 510 ( k ) or De Novo test . Both the legacy LDTs and the modified FDA-authorized tests will still need to meet certain Quality System requirements :
• By May 6 , 2025 : Medical Device reporting , Correction and Removal reporting and Quality System ( Complaint Files ) requirements
• By May 6 , 2026 : Establishment Registration and Device Listing , Labeling and Investigational Use requirements
• By May 6 , 2027 : Quality System ( Records ) requirements for both types of tests and additional requirements for tests that are LDTs due to modifications to an FDA-approved test ( Design Controls , Purchasing Controls , Acceptance Activities , and Corrective and Preventive Actions )
FDA will allow modifications to the legacy LDTs and FDA-approved tests if they do not :
• Change the indications for use of the IVD ,
• Alter the operating principle of the IVD ( for example , changes in critical reaction components ),
• Include significantly different technology in the IVD ( e . g ., addition of artificial intelligence or machine learning to the test algorithm , a change from targeted sequencing to whole genome sequencing , a change from immunoassay to mass spectrometry , or a change from manual to automated procedures ) or
• Adversely change the performance or safety specifications of the IVD . 1
New LDTs marketed after May 6 , 2024 , and those that do not fall under one of the enforcement discretion policies , will be subject to the Enforcement Discretion Phaseout Policy ( Figure 1 ), a four-year , fivestage transition that eases laboratories into meeting Quality System and premarket review requirements .
Public health surveillance tests , defined as those used strictly for surveillance and where the results are not returned to the patient or provider , are not affected by the Phaseout Policy .
Less pertinent to public health laboratories , FDA is allowing targeted enforcement discretion for LDTs for unmet needs when the laboratory and ordering provider are in the same healthcare system ( such as hospital laboratories and most academic medical centers ). FDA believes risk is mitigated in these situations because there is communication between the laboratory and the provider , and liability may be shared . Targeted enforcement discretion is also given for LDTs approved by the New York State Clinical Laboratory Evaluation Program . The other enforcement discretion policies are less pertinent to the majority of public health laboratories .
The FDA has many resources to help laboratorians understand these requirements , such as this overview and many recorded webinars , including a May 14 webinar specifically on the LDT Final Rule . They also intend to publish additional guidance documents , such as those on validation requirements and acceptable modifications .
Questions from APHL members are encouraged and welcomed at the LDTquestions @ aphl . org mailbox . Recurring themes are developed into frequently asked questions ( FAQs ) and published on the new member resources LDT webpage along with other important information , such as key facts with APHL interpretation , resources for implementing LDTs and a recorded APHL webinar .
APHL continues to advocate for a pathway for public health laboratories to conduct their unique and vital work and is here to support you during this transition . Please do not hesitate to contact us at LDTquestions @ aphl . org . g
28 LAB MATTERS Winter 2024
PublicHealthLabs @ APHL APHL . org