If your organization has already bellied up to the FDA bar and paid the $2,575 bar tab to FDA, and listed your medical devices through the FDA Unified Registration and Listing System (FURLS); then no worries, you are in compliance with 21 CFR, Part 807 (from an establishment registration perspective).

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?

Unfortunately, every one of the responses equates to poking a stick into the eye of a sleeping bear. When running from a ticked-off bear, you do not have to be the fastest runner; you just have to not be the slowest. However, with FDA, there is no running, only pain for failing to register as an establishment and to list the medical devices you manufacture, assemble, sterilize, distribute, etc.

For those of you living in a cave or oblivious to the ongoing change in the regulatory environment in the United States, on August 2, 2012, FDA sent an open letter to the medical device industry advising the industry of significant changes to the establishment registration process. The changes to establishment registration went into effect on October 1, 2012. As a result of the changes to the establishment registration process, Title 21 CFR, Part 807 was revised. (On another note; it sure would be nice if the agency updated their web site and posted the most current version of part 807. The doctor just checked and the April 1, 2012 version is still posted. With all of this additional revenue being paid into FDA as a result of expanding the establishment registration field, they could afford to update their website!) 

What the doctor truly finds amazing is that there are organizations out there that are now required to register but are failing to do so. For example, if you are a machine shop manufacturing bone screws for the orthopedics industry and you are the last ones touching the screws, you are a contract manufacturer and need to register. If you are operating an ethylene oxide sterilization facility in Timbuktu and the sterilized finish devices eventually make their way into the U.S. device market, you must register. In short, $2575 is the price of admission to play in the US medical device sandbox. Some of the salient changes to the establishment registration process are:

• 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.

Takeaways

For this edition of Devine Guidance, the doctor will leave the readers with just one pearl of wisdom. If you have not registered with FDA as an establishment and your organization meets the requirements delineated within Part 807, then what is stopping you? There is no time like the present to write the $2575 check to the agency. Failure to register when required to do so can result in the agency opening a can of regulatory whoop-ass resulting in varying degrees of pain. Can you say FDA has told us to stop shipping product? Can you say interruption of the revenue stream? In closing, the doctor hopes you have found some value in this week’s guidance. Cheers from Dr. D. and best wishes for continued professional success.

References: 

1. 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. 
2. 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.