Almost 60% of 510(k)s are rejected even before they have a chance to be approved under the FDA's December 2012 Refuse to Accept policy, designed to check for administrative completeness, according to a report from MD+DI.
Stakeholders worry that the policy could be slowing things down instead of speeding them up and complain of rejections for silly reasons like duplicate page numbers, whether a condom is patient contacting (yes, it is) and failure to state whether a vinyl glove contained software (no, it did not), or for technical reasons that are not administrative in nature.
Firms can be forced to file an infinite number of amended 510(k)s, said consultant Jorge Ochoa at the 10x Medical Devices Conference in Minneapolis on May 13, according to MD+DI. This would defeat the purpose of the policy, in which the FDA has promised to accept or reject all 510(k)s for substantive review within 15 days. Ochoa also said the device description and substantial equivalence sections are most likely to lead to a Refuse to Accept letter.
The FDA Law Blog concurs. Regarding the substantial equivalence section, attorneys Allyson Mullen and Jeffrey Gibbs wrote in February, "We remember the good old days when a 510(k) summary could just contain a few sentences comparing the proposed and predicate devices in terms of intended use and technological characteristics. … Furthermore, parsing the details of the 510(k) summary seems unrelated to the ability of the FDA to review the 510(k) itself--the stated purpose of the RTA [Refuse to Accept policy]."
Based on the examples we have seen, we question whether the 60% of rejected submissions are really 'low quality,' or, if the Center [CDRH] is being overly picky (and in some instances failing to use common sense), and consequently, has created a process that actually further delays the overall review time for 510(k)s rather than improving," the FDA Law Blog concludes.
Indeed, the acceptance checklist in the final guidance laying out the new policy is 62 pages long.
But at AdvaMed's 2013 annual meeting, CDRH director Jeffrey Shuren said the program is reducing inefficiencies by eliminating low-quality submissions early in the process, according to FDAnews. He recommended including the checklist in the submission and denoting it with the page number of each element so that reviewers don't overlook any of the elements.