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Radiological Health Reporting Survey / FDA

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CDRH is developing an electronic report submission process to be used in addition to the current paper process. We are designing the electronic format to be similar to the current reporting guide. The new electronic reporting guide will be very user-friendly, and will allow the attachment of electronic files, and will feature "smart" edit checks (address misspellings, all required data to be filled in, conflicting information, etc.).

Your participation in electronic reporting will be voluntary; for several more years we will continue to accept paper copies and we will continue entering them into the same database that the electronic reports will automatically be entered into. By automatically processing and screening the electronic reports we anticipate much quicker issuance of acknowledgement letters and technical reviews - the feedback to you, the manufacturers, consultants, and importers, who need it.

As we are developing the new system we want to hear from you to be sure we are considering your needs as well as our own. Please take a few minutes to fill out this survey of the industry so we can find out how you feel about this plan. If you have any questions, you may either call the Electronic Products Branch at: 301-594-4654, FAX: 301-594-4672, or email Ms. Cory Tylka at: cst@....

(Updated 2/6/02)

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