Through a recent draft guidance, FDA has proposed a new risk-based regulatory framework for Lab-developed Tests (LDTs), comparable to existing policies for in vitro diagnostic devices (IVDs).
Historically, LDTs have been developed at low-risk for the diagnosis of rare conditions with the intent to be used within a single organization, and therefore have not been required to obtain FDA approval as IVDs have. The agency has recently noticed an increase in complexity among LDTs, which raises the risk of inaccurate diagnoses, and has ultimately driven FDA to pursue more strict regulation.
On July 31, FDA submitted the guidance, Framework for Regulatory Oversight of LDTs, proposing a risk-based system for regulation. Those classified as “low risk” or intended to diagnose rare diseases will be exempt from most of the regulations, while high and moderate risk LDTs will be subject to more strict requirements.
- Low-risk (Class I): must meet FDA requirements for registration, device listing, and adverse event reporting.
- Moderate-risk (Class II): must meet all Class I requirements and begin reporting adverse events within six months of the final guidance. Class II devices will also need to go through premarket review beginning five years after the guidance is finalized.
- High-risk (Class III): will also need to begin reporting adverse events within six months and those devices with the “highest risk” will also require marketed review beginning one year after the guidance, while the remaining “high-risk” devices will be reviewed over the course of four years.
Following the guidance submission, various medical groups, politicians, and industry representatives have expressed concerns with FDA’s approach; many noting the importance of timely, and innovative diagnostic technologies for quality patient care.
To read Alexander Gaffney’s full article on RAPS.org, click here.
Read Andrew Pollack’s article in the NY Times here.
Also read Varun Saxena’s article on fiercemedicaldevices.com here.