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.
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.