Under FDA clearance rules, the de novo medical device clearance process, is for those devices that are not substantially equivalent to another legally market medical device and cannot be cleared under 510(k). Once rejected for clearance to market under 510(k), the company then files a de novo petition. But industry considers the process cumbersome as it’s known to delay further the clearance of a medical device for market.
Here is the draft guidance. The de novo process has been underused said the FDA and could be “improved and greater clarity could be provided regarding suitability and data needed so that the de novo process may be a more viable pathway for novel low to moderate risk devices.”
So here is how it would work. A company wants to market its device. If it is not similar to one on the market, the company would file a pre de novo submission or PDS. The company admits its product is completely novel but reminds the FDA it is low risk. Under the proposal, the FDA would also allow the manufacturer to also file a 510(k) clearance proposal doubling the chance for clearance.
The problem with building upon or expanding the 510(k) approval process is that it has many critics. An Institute of Medicine (IOM) report issued in July called the 510(k) clearance process “fatally flawed” because all sort of devices were being grandfathered in as substantially equivalent even though they may be made of different material, have a different function, and new technologies and complexities beyond what the original device ever dreamed of.
The IOM suggested scrapping the approval process and starting over.
Another question – How does one define low or moderate risk? Synthetic surgical mesh is considered a Class II or moderate-risk medical device even though the FDA has issued two warnings questioning its risk over benefit after thousands of patients have been injured.
Legislation passed by Congress in 1997 created the de novo process for devices that could not claim substantial equivalence.
“Right now, the de novo process is cumbersome and requires extra work and effort from manufacturers and the agency,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), said in a statement. “Creating a pathway for a concurrent 510(k) and de novo petition streamlines the de novo program, helping speed safe and effective devices to patients.”
What does industry think?
AdvaMed, Advanced Medical Technology Association, the manufacturer’s lobby group says in a statement that it is reviewing the guidance but that the current de novo process takes too long.
Dr. Shuren was a featured speaker at an AdvaMed conference last week.
This is one of the 25 action items the FDA planned earlier this year in promising to make changes to the 510(k) approval process. The public has 90 days to comment. The FDA’s website (here) outlines how you may comment. #