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U.S. Department of Health and Human Services

Medical Devices

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510(k) Pre-Review Form

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PRE-REVIEW FORM: COMPANY/DEVICE HISTORY

Please complete the pre-review form prior to beginning the review of this 510(k). This form is designed to be a tool to identify key items that may be important to consider regarding the regulation of the subject device and if you should even begin the review of the 510(k).

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.) 

 

 

 

 

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best of your knowledge, has a 510(k) previously been submitted for this specific device (i.e., previously found NSE or withdrawn)?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