The US Food and Drug Administration (FDA) needs to be clearer about what least burdensome submissions from the device industry look like, industry group AdvaMed and the law firm Hyman, Phelps & McNamara wrote in comments submitted on the draft guidance.
AdvaMed notes the draft guidance, released in December
, describes how the application of real world evidence is necessary to approve a PMA for a permanent pacemaker electrode and to support expanded indications for use of a cryosurgical tool for benign and malignant lesion ablation.
“More often, though, the guidance relies on high-level, limited discussions that reflect neither past practice nor scenarios in which least burdensome principles might apply,” AdvaMed said.
The draft also discusses shifting the use of premarket data for approvals to the postmarket setting but, according to AdvaMed, “Missing from this brief treatment of a ‘key principle’ is an example – drawn from FDA practice or an applicable fact pattern – of balancing pre- and postmarket information needs to reach a least burdensome result.”
Similarly, Hyman, Phelps & McNamara, said the recently approved 21st Century Cures Act
is the third time that “Congress has told FDA that the ‘least burdensome’ concept should be meaningfully incorporated into decision-making.”
For example, the law firm said, FDA has not adhered to the least burdensome principle when advising companies on what type of data are insufficient.
“The lack of rationale or explanation has been particularly problematic when the type or amount of data submitted or proposed is consistent with a predicate device (in the case of a 510(k)) or a similar device (in the case of a PMA),” the firm said.
The draft, once finalized, will replace FDA's 2002 guidance
detailing the concepts and principles of the least burdensome provisions laid out in FDAMA
to reflect the changes made in FDASIA
and the Cures Act