- Legislation that would reform how diagnostic tests are regulated, bringing lab-developed tests and in-vitro diagnostic tests under one risk-based framework, did not make it into Congress’ $1.7 trillion year-end funding package.
- Lawmakers previously said they would include the VALID, or Verifying Accurate Leading-edge IVCT Development, Act in the end-of-the-year legislation, after it was cut from the FDA user fee bill. A recent letter to House and Senate leaders from AdvaMed, the Pew Charitable Trusts and others urged them to pass the act.
- Some medical device provisions that were included in the omnibus funding bill include clinical trial diversity requirements, cybersecurity requirements, and an option to notify the FDA of supply disruptions for critical medical devices, according to the bill text.
The year-end spending bill needs to pass before midnight on Friday, when government funding expires. Advamed CEO Scott Whitaker expressed disappointment the final bill didn’t include the testing reform, which would clarify U.S. Food and Drug Administration oversight of lab-developed tests.
“VALID’s exclusion is very disappointing, especially since there was strong bipartisan support for both the policy and principles of a level playing field, and of ensuring all tests are safe, effective, and work as intended,” Whitaker said in an emailed statement. “The last thing we need is more Theranos-type tests in our healthcare system.”
Some provisions supported by the medical device lobbying group did make it into the bill. They would:
- Allow the FDA to approve a predetermined change control plan that describes planned changes that may be made to a medical device. This provision would be useful for software devices, where changes might need to be made to a device over time. Cleared devices could submit a predetermined change control plan in a notification.
- Appoint a permanent director of pandemic preparedness and response policy within the White House.
- Give the Biomedical Advanced Research and Development Authority the authority to establish and maintain domestic manufacturing surge capacity, including for diagnostic testing supplies.
Advamed said it is “looking carefully” at the clinical trial changes, which require the FDA to take “a series of actions intended to modernize and improve clinical trials including increasing the diversity and engagement of trial participants.”
The group said it is also analyzing the new cybersecurity requirements, which would authorize the FDA to deny 510(k) clearance for a device if cybersecurity information is inadequate.