Regulatory Open Forum

The company I work for is a contract manufacturer as defined by the FDA.   Outside of medical work we also do manufacturing for many in the electronics industry.  We also do electronics repair for people in the electronics industry.  We have been contacted by a potential customer about service of their medical devices.  These products consists of electronics inside a plastic housing like thermometers, EKG monitors, pulse oximeters, etc.  What complicates this is the service repair work will be done outside the US.  So the product would go from the hospital to a US staging area on the US border.  We would then decontaminate the product in the US and ship the product to our service site, service the product outside the US and ship it back to our staging area.  We would then ship the product from our staging area back to the hospital.  We are using the staging area as most hospitals won't have the expertise to understand how to do international shipments, deal with import/export regulations and to follow the appropriate decontamination processes to ensure that there are no issues crossing the border.  This will be a regular flow of units per day. 

 My questions:

• When we ship these units outside the US are there any export laws that we need to be aware of from the FDA's point of view?
• When these products come back to the US after repair they are not new, but used.  These devices are all 510(k) products.  Typically US customs looks at inbound NEW regulated products to determine if they have a valid 510(k) or PMA.  How will they review these used products?
• Are there any other regulations that come to mind that we should be aware of that people can suggest we review and understand?

The company I work for is a contract manufacturer as defined by the FDA.   Outside of medical work we also do manufacturing for many in the electronics industry.  We also do electronics repair for people in the electronics industry.  We have been contacted by a potential customer about service of their medical devices.  These products consists of electronics inside a plastic housing like thermometers, EKG monitors, pulse oximeters, etc.  What complicates this is the service repair work will be done outside the US.  So the product would go from the hospital to a US staging area on the US border.  We would then decontaminate the product in the US and ship the product to our service site, service the product outside the US and ship it back to our staging area.  We would then ship the product from our staging area back to the hospital.  We are using the staging area as most hospitals won't have the expertise to understand how to do international shipments, deal with import/export regulations and to follow the appropriate decontamination processes to ensure that there are no issues crossing the border.  This will be a regular flow of units per day. 

 My questions:

• When we ship these units outside the US are there any export laws that we need to be aware of from the FDA's point of view?
• When these products come back to the US after repair they are not new, but used.  These devices are all 510(k) products.  Typically US customs looks at inbound NEW regulated products to determine if they have a valid 510(k) or PMA.  How will they review these used products?
• Are there any other regulations that come to mind that we should be aware of that people can suggest we review and understand?

The company I work for is a contract manufacturer as defined by the FDA.   Outside of medical work we also do manufacturing for many in the electronics industry.  We also do electronics repair for people in the electronics industry.  We have been contacted by a potential customer about service of their medical devices.  These products consists of electronics inside a plastic housing like thermometers, EKG monitors, pulse oximeters, etc.  What complicates this is the service repair work will be done outside the US.  So the product would go from the hospital to a US staging area on the US border.  We would then decontaminate the product in the US and ship the product to our service site, service the product outside the US and ship it back to our staging area.  We would then ship the product from our staging area back to the hospital.  We are using the staging area as most hospitals won't have the expertise to understand how to do international shipments, deal with import/export regulations and to follow the appropriate decontamination processes to ensure that there are no issues crossing the border.  This will be a regular flow of units per day. 

 My questions:

• When we ship these units outside the US are there any export laws that we need to be aware of from the FDA's point of view?
• When these products come back to the US after repair they are not new, but used.  These devices are all 510(k) products.  Typically US customs looks at inbound NEW regulated products to determine if they have a valid 510(k) or PMA.  How will they review these used products?
• Are there any other regulations that come to mind that we should be aware of that people can suggest we review and understand?

The company I work for is a contract manufacturer as defined by the FDA.   Outside of medical work we also do manufacturing for many in the electronics industry.  We also do electronics repair for people in the electronics industry.  We have been contacted by a potential customer about service of their medical devices.  These products consists of electronics inside a plastic housing like thermometers, EKG monitors, pulse oximeters, etc.  What complicates this is the service repair work will be done outside the US.  So the product would go from the hospital to a US staging area on the US border.  We would then decontaminate the product in the US and ship the product to our service site, service the product outside the US and ship it back to our staging area.  We would then ship the product from our staging area back to the hospital.  We are using the staging area as most hospitals won't have the expertise to understand how to do international shipments, deal with import/export regulations and to follow the appropriate decontamination processes to ensure that there are no issues crossing the border.  This will be a regular flow of units per day. 

 My questions:

• When we ship these units outside the US are there any export laws that we need to be aware of from the FDA's point of view?
• When these products come back to the US after repair they are not new, but used.  These devices are all 510(k) products.  Typically US customs looks at inbound NEW regulated products to determine if they have a valid 510(k) or PMA.  How will they review these used products?
• Are there any other regulations that come to mind that we should be aware of that people can suggest we review and understand?