Devices

FDA Posts Laboratory-Developed Test FAQs

FDA has posted a Web page of frequently asked questions (FAQs) about its new final rule on laboratory-developed tests (LDTs). The post covers definitions and general oversight, phaseout policy and enforcement discretion policies, labeling, premarket review, investigational use, specific test categories or technologies, and resources and interactions with FDA.

The FAQ post explains that the agency is phasing out its enforcement discretion approach to help assure the safety and effectiveness of in vitro diagnostics (IVDs) offered as LDTs. It says the final rule includes an enforcement discretion policy for currently marketed IVDs offered as LDTs in consideration of concerns that expecting compliance with full quality system and premarket review requirements for such IVDs could lead to a loss of access to safe and effective IVDs on which patients currently rely. There also is an enforcement discretion policy for LDTs manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system in consideration of concerns that expecting compliance with full FDA requirements could lead to a loss of access to such LDTs for which laboratories cannot recoup the costs of compliance.

On a question about the stages of the phaseout policy, FDA says the timelines for the phaseout policy stages are set for one to four years after the 5/6 publication date of the final rule.

Asked whether enforcement discretion applies to investigational LDTs, FDA says it has included compliance with investigational use requirements for IVDs offered as LDTs in stage 2 in recognition that there has been some confusion about the enforcement approach in this area.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome