I am writing to follow up on the meeting that you and your associates held with the Center for Devices and Radiological Health on October 21, 2003. The meeting provided CDRH with an opportunity to hear your issues and public health concerns.
The underlying concern seems to be the difficulties that limit successful third party servicing of diagnostic imaging equipment. The existing regulatory scheme was developed with primary focus on new product manufacturers and devices. Today, third party servicing is a significant part of health care and appears likely to remain so. You expressed the need for access to information that will allow long term maintenance of medical imaging equipment, to provide optimal performance for patients at competitive prices.
Since the meeting, the Center has begun further review of broad radiation health priorities. In addition, we are gathering information about the specific issues you raised. We are conducting a literature review on the public health issues involved. We have begun asking major public health organizations for their perspective on this issue. We are also seeking ways to work with industry and professional groups to find voluntary solutions to the issues you described. I expect all this to take several months, and the outcome will depend on the priorities that are set for upcoming work.
We recognise that your concerns are part of a larger picture that includes reuse of many medical devices, third party servicing of medial devices and imaging products, and refurbishing / remarketing of products. The FDA has been working to address some of these issues. Others relate to financial aspects of health care management that reach well beyond the scope of our Agency. It may be difficult for our Center to effectively influence all of the broader issues you have discussed.
At the meeting, more specific issues were raised by Mr. Lauver and Mr. Adams. We have reviewed these issues, based on the information available, and are sending them individual letters in follow up. They are welcome to share these letters with you and other participants of the meeting. I hope they find them helpful.
We have also looked into some of the practical issues raised in the meeting, such as availability of 510(k) numbers for export documentation. As I understand it, export certificates for newly manufactured products are usually requested by the manufacturer, who has access to the 510(k) number. For someone else sending/taking a newly marketed product to another country, the 510(k) number should be available through the CDRH website. I think the example used at the meeting was someone taking a used device into another country. I've been told that FDA does not grant export certificates for used devices.
If the 510(k) number is needed for another reason, it may difficult to obtain. As we discussed at the meeting, there are limits to the information FDA has available. Changes to the Registration and Listing program might help tie 510(k) numbers to manufacturers, but this is unlikely to happen until we move to an electronic system. Initial planning is under consideration but I expect it will be some years in the future. It should be noted that such changes will still not directly tie 510(k) numbers to model numbers of products. That may require major regulatory changes in our programs that seem unlikely to happen.
I will write again if new information becomes available or there significant changes in policy. Please continue to direct all correspondence with CDRH to me. Thank you.
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Tom Quinn
fda letter
December 17, 2003 05:55
Mr. Quinn,
I am writing to follow up on the meeting that you and your associates held with the Center for Devices and Radiological Health on October 21, 2003. The meeting provided CDRH with an opportunity to hear your issues and public health concerns.
The underlying concern seems to be the difficulties that limit successful third party servicing of diagnostic imaging equipment. The existing regulatory scheme was developed with primary focus on new product manufacturers and devices. Today, third party servicing is a significant part of health care and appears likely to remain so. You expressed the need for access to information that will allow long term maintenance of medical imaging equipment, to provide optimal performance for patients at competitive prices.
Since the meeting, the Center has begun further review of broad radiation health priorities. In addition, we are gathering information about the specific issues you raised. We are conducting a literature review on the public health issues involved. We have begun asking major public health organizations for their perspective on this issue. We are also seeking ways to work with industry and professional groups to find voluntary solutions to the issues you described. I expect all this to take several months, and the outcome will depend on the priorities that are set for upcoming work.
We recognise that your concerns are part of a larger picture that includes reuse of many medical devices, third party servicing of medial devices and imaging products, and refurbishing / remarketing of products. The FDA has been working to address some of these issues. Others relate to financial aspects of health care management that reach well beyond the scope of our Agency. It may be difficult for our Center to effectively influence all of the broader issues you have discussed.
At the meeting, more specific issues were raised by Mr. Lauver and Mr. Adams. We have reviewed these issues, based on the information available, and are sending them individual letters in follow up. They are welcome to share these letters with you and other participants of the meeting. I hope they find them helpful.
We have also looked into some of the practical issues raised in the meeting, such as availability of 510(k) numbers for export documentation. As I understand it, export certificates for newly manufactured products are usually requested by the manufacturer, who has access to the 510(k) number. For someone else sending/taking a newly marketed product to another country, the 510(k) number should be available through the CDRH website. I think the example used at the meeting was someone taking a used device into another country. I've been told that FDA does not grant export certificates for used devices.
If the 510(k) number is needed for another reason, it may difficult to obtain. As we discussed at the meeting, there are limits to the information FDA has available. Changes to the Registration and Listing program might help tie 510(k) numbers to manufacturers, but this is unlikely to happen until we move to an electronic system. Initial planning is under consideration but I expect it will be some years in the future. It should be noted that such changes will still not directly tie 510(k) numbers to model numbers of products. That may require major regulatory changes in our programs that seem unlikely to happen.
I will write again if new information becomes available or there significant changes in policy. Please continue to direct all correspondence with CDRH to me. Thank you.
Kimber Richter
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