Cover letter
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a. Cover Letter
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Please include a cover letter that clearly states the reason for the submission
in the reference line (e.g., Pre-Sub for a 510(k), Pre-Sub for an IDE, Pre-Sub
for an IND or BLA) and, for CDRH submissions, please clearly indicate that the
submission is a Pre-Sub on the CDRH Premarket Review Submission Cover Sheet.
24 Use of the CDRH Premarket Review Submission Cover Sheet for submissions made
to CBER is highly recommended. 

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Pre-Sub for
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For CDRH submissions, the addressee may be the appropriate branch or branch
chief if the applicant knows where the subject device or similar devices are
reviewed. For CBER submissions, the addressee may be the appropriate Office
Director or Regulatory Project Manager where the subject device or similar
devices are reviewed. The cover letter should 
  

    http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm27

    9288.htm 24 CDRH Premarket Review Submission Cover Sheet available at 

    http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM080872.pdf ontains Nonbinding Recommendations 


contain complete contact information (i.e., the company name, address, contact
person, phone number, fax number, and email address). In addition to describing
the reason for the submission in the reference line, the cover letter should
also clearly identify the name of the device and include the signature of the
contact person, or other responsible party.