- FDA on Friday issued a notice responding to comments on last year's draft guidance on the 510(k) Third Party Review Program, saying it disagrees with remarks suggesting the program reduces patient safety and increases the burden on patients and doctors to figure out which devices are safe.
- The agency said the burden is on the third party to provide a review that is equivalent to an FDA review, and its guidance lays out the considerations it will use to ensure only appropriate devices are eligible for the program.
- In response to other suggestions, FDA removed a reference to scientific and technical data under the definition of a 510(k) submitter and clarified language on who should receive copies of communications and on the contents of the initial review memo.
When it rolled out its draft guidance, mandated by the FDA Reauthorization Act of 2017, FDA said outsourcing review of lower-risk devices could enable the agency to focus resources on more complicated, higher-risk devices. The draft guidance was intended to help ensure that the program maintains FDA's standards, former Commissioner Scott Gottlieb said at the time.
Under the program, after the outside party recommends a determination of substantially equivalent or not substantially equivalent, FDA makes the final decision on the 510(k) submission. To cut down on re-reviews, FDA said it would use a new authority in FDARA allowing the agency to tailor which devices are eligible for third party review.
FDA will look at factors "including whether the device type is implantable, life sustaining, life supporting, and well understood" when choosing which devices are eligible for outside review, according to the guidance.
In its comments, the USA Patient Network criticized the proposal as "allowing the FDA to skip reviews of third party assessments for 510(k) devices," calling the plan "yet another step back" from the standards of safety and effectiveness.
"To follow through with this guidance amounts to a betrayal of both Congress' charge and the trust the American people have placed in the agency to do due diligence in providing reasonable assurance of the safety and effectiveness of our medical treatments," the group said.
In its newly posted responses to comments on the draft guidance, FDA noted that devices cleared through the third party review program must demonstrate substantial equivalence to a legally marketed device, just as all devices subject to the 510(k) requirements must do.
"FDA reviews that information to make a final determination of substantial equivalence and where appropriate, FDA will limit its review to a supervisory-level review. Therefore, the burden to demonstrate substantial equivalence remains unchanged," the agency said in its response.
The guidance also says a third party organization should be impartial and free from any conflicts of interest as a criteria to be eligible to conduct 510(k) reviews. Third parties cannot be owned by a manufacturer, supplier or vendor and cannot help design, manufacture, sell or market devices.