FDA医疗器械2013财年新政问答 (2012年10月1日起实施)

来源：FDA

FDA 2012年10月1日后新政策的问答：

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm?source=govdelivery

Frequently Asked Questions about the New Device Registration and Listing Requirements

This list of FAQs is being provided to assist medical device establishments with understanding the new requirements and responsibilities for registration and listing that will become effective October 1, 2012. Please refer to FDA’s August 2nd letter to medical device establishments for further detail.

Changes to Device Registration and Listing注册和列名相关的变更

1. What are the changes to device registration and listing requirements, effective Oct. 1, 2012?

The changes are:

• All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
• Combination products – products comprising a device and a biological product or a drug – must be identified as a combination product and the type of combination product (for example, convenience kit, prefilled drug delivery device, etc.) must be selected from the list displayed in the FDA Unified Registration and Listing System (FURLS).
• All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
• Initial importers must identify the manufacturers of the devices they are importing.
• Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
• A device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or repacker/relabeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
• Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment” as required by 21 CFR 820.198.
• Establishments located in foreign trade zones must now register and list, as well as identify themselves as being located in a foreign trade zone.
• All establishments that are required to register must now pay the annual registration user fee as required by Food and Drug Administration Safety and Innovation Action (FDASIA). The Secretary of the United Stated Department of Health and Human Services may grant a waiver or reduction to the fee only if it is determined to be in the interest of public health and the total of waivers granted does not exceed 2% of total fee revenue amounts established for the year.

Updating Existing Registration and Listing Information 现有注册和列名的更新相关

2. How do I update information for the owner/operator or official correspondent?

Information for the owner operator and official correspondent is created and updated in the Account Management module of FURLS, accessed from the menu on the left side of the screen after logging into FDA Industry Systems at https://www.access.fda.gov/oaa/. The information you enter here for your account profile is automatically transferred to your Device Registration and Listing Module (DRLM) records as the owner operator information. To add, change, or delete an official correspondent other than the owner operator, you can create, update, deactivate, or reactivate a subaccount for that official correspondent. You then choose your official correspondent when you register a facility or update an existing registration for a facility.

Proprietary (Brand) Names 产品和商标名称等相关

3. Do I have to add all of the proprietary names of my device? How many proprietary names can I add to my listing?

Yes, the account holder should include all current proprietary names (or brand names). There is no limit to the number of proprietary names that can be added. The names can now be uploaded from an Excel spreadsheet or entered manually via DRLM.

4. We currently have our in-house brand and we private-label for a number of companies in the U.S. Do we need to include the proprietary names for each of the brands that we private-label for?

Yes, your device listings should include all of the current proprietary names that are used to market the devices you make in the U.S.

5. Do we have to include all proprietary names that our listed device has ever been marketed under?

No, you need only provide the names that the device is currently marketed under.

6. We do not have any proprietary names for our device, can we just fill in that field with what the device is (e.g., a scalpel)?

You may enter the model number if one exists or whatever identifier you apply to the device.

7. Should I include model numbers as part of the proprietary name?

Model numbers may be included as the proprietary name or part of the proprietary name, as appropriate.

8. We make different devices at different establishments that are listed under the same device code or submission number. Do we need to identify proprietary names on an establishment by establishment basis?

The proprietary name need only be identified at the owner operator level, not the establishment level. You will not identify the names on an establishment-by-establishment basis.

9. How long do we have to edit existing device listings and to add all of our proprietary names?

You should update your proprietary names during the annual registration cycle from October to December 2012; however, FDA is not requiring that all proprietary names be added until March 31, 2013.

Combination Products合并性产品相关

10. We are assembling first aid kits that have alcohol disinfectant wipes in them. Does that count as a combination product? How does FDA define a combination product?

Yes, the kit would be considered a combination product if the wipes are being used on the person rather than on the other devices. Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

11. When registering, will I have to list my combination products with the Center for Devices and Radiological Health (CDRH), as well as the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)?

Any combination product for which a 510(k) or PMA number was assigned should be listed with CDRH. This includes 510(k)s and PMAs reviewed by Center for Biologics Evaluation and Research (CBER) that have a “BK” or “BP” number. You are required to list your product only with the center that had the lead for review of your device; however, you may list your CDRH-reviewed device/drug combination with CDER as well, if desired.  

Medical Device Excise Tax医疗器械消费税相关

12. Is the Medical Device Excise Tax part of the Annual Registration User Fees?

The Medical Device Excise Tax is not part of the Annual Registration User Fee, is not related to any of the changes to registration and listing requirements, and is not enforced, collected, or implemented by FDA. Please visit the Internal Revenue Service website for more information on this tax.

Foreign Establishments, Exporters, Importers, and Contract Manufacturers and Sterilizers美国国外的公司，出口商，进口商和合同制造商/灭菌商相关

13. Can an individual represent a foreign establishment as its U.S. agent and its official correspondent?

Yes, but as the U.S. agent, the individual must reside or have a place of business in the United States.

14. Must a foreign establishment that is now required to provide the names of all known importers of its devices continue to update this information in FURLS when it changes?

Yes. A foreign establishment must provide this information during initial registration, annual registration, and at the time of any changes.  

15. As a foreign establishment that is now required to provide the names of all known importers of my devices, will this information be on the public website?

16. As an initial distributor/importer who is now required to provide the manufacturer information for devices I will be importing, must I update this information in FURLS as new firms are added or I decide not to distribute for a particular manufacturer?

FDA recommends that importers keep their manufacturer information current at all times. Failure to keep your information current may lead to your device undergoing manual review when imported, which may slow importation of your device.

17. As an initial distributor/importer that is now required to provide the manufacturer’s information for devices I will be importing, will this information be shared on the public website?

No.

18. I am a foreign exporter, contract manufacturer, or contract sterilizer and I am trying to list a non-exempt device and the system will not allow me to proceed? I am using the correct 510(k) number. Why can’t I list this device?

The device must be listed by a manufacturer, remanufacturer, single-use device reprocessor, specification developer, or repacker/relabeler before you can list the device. You should check with your customer, manufacturer, or specification developer to make sure they have listed the device, or you can search for the listing on the FDA web site.

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