Changes Urged to 510(k) ‘Refuse to Accept’ Policy

Posted by Brian Buntz on November 5, 2012

Medical device trade associations and companies are telling CDRH that while its draft guidance on a Refuse to Accept Policy for 510(k)s makes a good start at meeting the mandates in MDUFA III, some changes should be made to it.
In recent comments filed with FDA on the draft guidance, the Medical Imaging and Technology Alliance (MITA) noted that a key part of the MDUFA III agreement was FDA’s commitment to streamline the device review process to improve agency timeliness. The intent was to reform the Refuse to Accept process to focus reviewer time and energy on only those submissions that are complete, it says.

MITA said the Center should ensure that all criteria included in Refuse to Accept checklists are objective and clearly defined. Despite several draft guidance statements reinforcing the principle of using objective criteria to make Refuse to Accept decisions, MITA said it several checklist criteria appeared to entail subjective judgments by review staff.

The comment letter said CDRH should also clarify the date at which the review clock starts and how it will communicate that date to submitters. And it said that the process of notifying submitters of a positive or negative acceptance decision should be further clarified and structured to expedite the review process. 

In other comments, Novo Nordisk said it found some inconsistencies between the Refuse to Accept policy and other CDRH 510(k) guidances. 

AdvaMed wrote that although the draft guidance clearly stated that the purpose of 510(k) acceptance review was to assess whether a submission is administratively complete, there are some items in the acceptance checklists that require responses that could only be provided if a substantive review has been conducted. 

AdvaMed criticized CDRH for limiting its acceptance review to prescreening of 510(k) submissions and determining whether an element is present rather than determining whether it is substantively acceptable.

Zimmer, Inc. asked whether a reviewer’s Refuse to Accept checklist will be posted on the agency Web site. It asked that the checklists not be posted and not be made available in response to a Freedom of Information request because it may give competitors proprietary information. 

Finally, the Orthopedic Surgical Manufacturers Association said that the guidance provides a clear and organized checklist outlining information to be included in a 510(k) application. It suggested additional agency clarification on several specified items that were not included in the checklist and are required for some device applications to receive clearance.

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