Rosina Robinson, RN, MEd, RAC - Comment

Thank you for the opportunity to comment on this significant step forward in the CDRH review process for 510(k)s. It resumes the process that was present several years ago and then appeared to have been abandoned. My comments are shown by Guidance section and Page. 1. 510(k) Refuse to Accept Policies and Procedures; Page 8: The Guidance states that the reviewer should not make determinations of the adequacy of the information for determining substantial equivalence during the screening process. In this situation, it is unclear that the screening process will actually have a significant impact in the time to clearance metric. 2. Acceptance checklist for Traditional 510(k)s; Page 3: (a) No reference to the payment of the Medical Device User Fee/User Fee Cover Sheet is made. Will this be a criterion as to the RTA decision? (b) No reference is made to the presence of the CDRH Premarket Review Cover Sheet. Will this be a criterion as to the RTA decision? NOTE: THESE COMMENTS APPLY TO ALL THREE SCREENING CHECKLISTS. Page 6: It is my understanding that compliance with FDA guidance documents is not mandatory. Therefore, are you just looking for recognition that the submitter is "aware" that the guidance exists or will be compliance with guidance now be required and when was this requirement implemented? See standard statement present for guidance documents: "It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations " NOTE: THIS COMMENT APPLIES TO ALL REFERENCES RELATED TO GUIDANCE DOCUMENT COMPLIANCE. 3. Acceptance checklist for Special 510(k)s: Page 6. Since Special 510(k)s require the predicate to be the sponsor's own device, some of the statement relating to predicate device/s do not apply.