For those of you working for organizations that have failed to register as an establishment, Dr. D has provided a “myriad” (look-it-up) of excuses you can give to FDA when they magically appear on your facility’s door step.
- We could not afford the $2575.00 registration fee.
- We did not think our product is a medical device.
- We are just a contract manufacturer.
- We only import and export medical devices.
- We are not a US-based device manufacturer.
- We only sterilize devices.
- We like to push the limit and ignore laws.
- What’s Part 807?
- Who is FDA?
- If your organization is required to register as an establishment, then you must pay to play, so if you have not already done so, write that check for $2575.
- Device manufacturers (foreign and domestic) are required to register with FDA, pay the man.
- Contract manufacturers (foreign and domestic) are required to register with FDA, pay the man.
- Contract sterilizers (foreign and domestic) are required to register with FDA, pay the man.
- Device manufacturers are required to list their products with FDA through the use of FURLS.
- Contract manufacturers and sterilizers are required to list the products they manufacture and sterilize, including the medical device they are performing the work for using FURLS.
- In fact, Devices are now required to be listed by the: (a) manufacturer; (b) specification developer; (c) device re-processors; (d) re-manufacturers; (e) device re-packers; and (f) device re-labelers; before listing by foreign exporters; contract manufacturers, or contract sterilizers.
- Food and drug administration safety and innovation act (FDASIA). (2012, July). FDA Website. Retrieved April 20, 2013, from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.
- Medical device establishment registration and listing – notice of changes for FY 2013. (2012, August). FDA Website. Retrieved April 20, 2013, from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm.