(a)
(b)
(c)
(2) Once you complete your electronic update, FDA will automatically provide you with an electronic confirmation of your update.
(3) Your registration will be considered updated once FDA transmits your update confirmation, unless notified otherwise.
(d)
(1) You must update your registration using Form 3537. You may obtain a copy of this form by writing to the U.S. Food and Drug Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857 or by requesting the form by phone at 1-877-FDA-3882 (1-877-332-3882).
(2) When you receive the form, you must legibly fill out the sections of the form reflecting your updated information and either mail it to the address in paragraph (d)(1) of this section or fax it to 301-436-2804 or
(3) If the information on the form is incomplete or illegible when FDA receives it, FDA will return the form to you for revision, provided that your mailing address or fax number is legible and valid. When returning a registration form for revision, FDA will use the means by which the registration was received by the agency (
(4) FDA will enter complete and legible updates into its registration system, along with CD-ROM submissions, as soon as practicable, in the order FDA receives them.
(5) FDA will then mail to the address or fax to the fax number on the registration form a copy of the update as entered and confirmation of the update. When responding to an update submission, FDA will use the means by which the form was received by the agency (
(6) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update.
(7) Your registration will be considered updated once FDA enters your facility's update data into the registration system and the system generates an update confirmation.
(e)
(1) Registrants submitting their updates in CD-ROM format must use ISO 9660 (CD-R or CD-RW) data format.
(2) Update files must be submitted on a PDF rendition of FDA's registration form (Form 3537) and be accompanied by one signed copy of the certification statement on the registration form (Form 3537).
(3) Each submission on the CD-ROM must contain the same preferred mailing address in the appropriate block on Form 3537.
(4) The CD-ROM may contain updates for as many facilities as needed up to the CD-ROM's capacity.
(5) The update for each facility on the CD-ROM must have a unique file name up to 32 characters long, the first part of which may be used to identify the parent company.
(6) You must mail the CD-ROM to U.S. Food and Drug Administration (HFS-681), 5600 Fishers Lane, Rockville, MD 20857.
(7) If FDA receives an update CD-ROM that does not comply with these specifications, it will return the CD-ROM to the registrant unprocessed.
(8) FDA will enter CD-ROM update submissions into its registration system, along with the complete and legible mailed and faxed update submissions, as soon as practicable, in the order FDA receives them.
(9) For each facility on the CD-ROM, FDA will mail to the preferred mailing address a copy of the update(s) as entered and confirmation of the update.
(10) If any update information you previously submitted was incorrect at the time of submission, you must immediately resubmit your update.
(11) Your registration will be considered updated once FDA enters your facility's update data into the registration system and the system generates an update confirmation.