US Food and Drug Administration (FDA) draft guidance drew criticism from industry because of certain deadlines related to Form 483 nonbinding feedback.
The February draft guidance
proposes a standardized method to request FDA feedback on remediation actions for 483 citations without holding a medical device establishment to a promise after an inspection.
Yet the draft guidance waters down the method’s utility, comments made public earlier this week argue.
The public comment period on the draft guidance closed with submissions from trade association AdvaMed, the Bringing Real-world Insight for Device Governance and Evaluation (BRIDGE) Coalition and Cook Group—all of which caution against making the nonbinding feedback channel too narrow in scope.
Commenters argue the draft guidance fails to deliver on least burdensome principles of the FD&C Act
. Their concerns relate to being overly restrictive with the 15-day grace period for submitting a nonbinding feedback request, the three eligibility criteria on requests and the one-time exchange of information. They also express concerns with the long 45-day window for the agency to either notify a device establishment of a request’s ineligibility or provide nonbinding feedback.
FDA feedback “helps to assure that the remediation effectively and efficiently resolves quality system deviations,” said AdvaMed senior executive vice president of technology and regulatory affairs Janet Trunzo. But the draft guidance “does not deliver these results.” Its “overly restrictive reading is evident in its explanation of public health priorities, systemic or major actions and emerging safety issues.”
Trunzo cited a 2018 blog post from FDAzilla—a platform for FDA inspection analytics—that reported on the impact a bad 483 can have on a bottom line, with remediation costs racking up to thousands or millions. The 15-day deadline to submit a request “constrains thoughtful, well-researched remediation proposals,” Trunzo said. Cook Group echoed AdvaMed’s concerns on this deadline and the one-time exchange. “This amount of time is commonly inadequate for a full root cause response assessment,” said Stephen Ferguson, chairman of the Cook Group board. “The one-time request also does not allow for revision of inadequately effective action plans due to fear of deviation from prior promises” to FDA.
AdvaMed and Cook Group recommend an ongoing exchange and extending the 15-day grace period on submitting nonbinding feedback requests to better serve the interests of establishments, FDA and patients. AdvaMed recommended allowing 45 days after an establishment determines action is needed in response to a 483, citing benefits in first fully understanding root causes and revising ineffective action plans.
Commenters said the eligibility criteria could hinder meaningful access to FDA feedback, arguing that these would only be applicable to a minority of establishments conducting remediation. “Surely FDA agrees that the benefit to patients from avoiding all injury, including those that may result from device shortages, outweighs its investment to review and comment on firms’ remediation plans,” said Trunzo.
The agency should notify of requests rejected within 15 days of receipt so that requests can be accordingly adjusted, argues Leavitt Partners principal and advisor to the BRIDGE Coalition Ralph Hall.