As part of its ongoing overhaul of the 510(k) process, CDRH released finalized guidances on its special 510(k) and abbreviated 510(k) programs, on its refuse-to-accept policy for 510(k)s and on formatting recommendations for submissions.
The programs are evolving to reflect advances in materials, digital health, 3D printing and other technologies, as the agency moves ahead with its Medical Device Safety Action Plan unveiled last year.
“The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients,” said CDRH Director Jeffrey Shuren, in announcing new steps to modernize the program late last year.
The Special 510(k) program previously only covered reviews of changes that didn’t affect the device’s intended use or alter its base technology. Now, the agency is focusing on whether the change evaluation methods are well-established. The final guidance clarifies the FDA’s policy on changes that are appropriate under the program.
CDRH says the new policies regarding the factors to consider when determining if a change to an existing device can be submitted through the Special 510(k) pathway will be “operationalized immediately.”
The final guidance on the Abbreviated 510(k) program, which establishes substantial equivalence based on special controls or voluntary consensus standards, supplements other 510(k) guidances with information on specific submission requirements and recommendations.
The refuse-to-accept policy for 510(k)s guidance explains the agency’s procedures and criteria for accepting 510(k)s for substantive review. It describes the content required in traditional, abbreviated and special 510(k) submissions to enable the agency to conduct timely reviews.
The review process “is captured in the acceptance checklists for traditional, abbreviated, and special 510(k) submissions, which FDA staff will use during the acceptance review process,” the guidance says.
Although the new policy goes into effect immediately, CDRH anticipates that “both FDA and industry may need up to 60 days to operationalize the associated updates to the refuse-to-accept guidance.”
Until Nov. 13, 2019, once the agency has determined a submission is appropriate for review as a Special 510(k), it intends to use the prior final refuse-to-accept guidance to assess whether a submission meets a minimum threshold of acceptability and should be accepted for review.
The final guidance on how to format traditional and abbreviate 510(k)s — which replaces November 2005 guidelines — describes 20 sections each submission should include and lists resources for further information. The document provides “a general framework” and doesn’t get into specific device types, special 510(k)s or other submission types.
Read the Special 510(k) guidance here: www.fdanews.com/09-13-19-Special510kProgram.pdf.
Read the Abbreviated 510(k) guidance here: www.fdanews.com/09-13-19-Abbreviated510k.pdf.
Read the Refuse to Accept policy guidance here: www.fdanews.com/09-13-19-RefuseAccept510k.pdf.
Read the formatting guidance here: www.fdanews.com/09-13-19-format510kguidance.pdf. — James Miessler