510(k) Pre-Review Form

If you answer YES to questions 1, 2 or 3; do NOT begin the review of this 510(k):

YES

NO

• Are you aware of the submitter being the subject of an integrity investigation?

• Is the device exempt from 510(k) by regulation (Please see 510(k) exempt form) or subject to enforcement discretion (No regulation - See 510(k) Staff)?

• Does this device type require a PMA by regulation?

(Please see management.)

Questions 4-8 are intended to help you start your review:

YES

NO

1. Is this 510(k) a candidate for “Refuse to Accept”?

(If so, please use the Traditional/Abbreviated or Special 510(k) Refuse to Accept Screening Checklist)

1. a. Did the firm request expedited review? (See management.) 

• Was expedited review granted? (See Guidance for Industry and FDA Staff: Expedited Review of Devices for Premarket Submissions)

1. To the best of your knowledge, was there a
   pre-IDE, 513(g) or other pre-submission for this type of device?

Please list document number and/or date, here:

1. To the best of your knowledge, has a 510(k) previously been submitted for this specific device (i.e., previously found NSE or withdrawn)?

Please list document number, here:

1. Does this device have indications or technology that are cross-cutting and impact the review policy of another branch(es)? (Please contact other branch(es) and see Guidance for Industry and FDA Staff on Bundling Multiple Devices or Multiple Indications in a Single Submission )