New FDA Draft Guidance on 510(k) Ownership and Use

M

MIREGMGR

FDA published a new Draft Guidance today:

(broken link removed)

Much of this guidance simply repeats the several-year-existing direction that the party responsible for marketing of a device must List it using the FURLS online system, and must be the party responsible for the relevant 510(k) for the device if one is required.

The guidance however also includes this statement that to my understanding represents an extension of prior rules. I quote the first sentence only to provide context for the second sentence, which is important and I have bolded:

Because contract manufacturers and sterilizers, foreign exporters, and foreign private label distributors are not responsible for the commercial distribution of devices, they would not be 510(k) holders, and should list the product under their customer’s 510(k) number once it has been listed by the 510(k) holder. Any entity that fails to list as required renders the device misbranded.

A requirement that contract processors must List has existed for several years. FDA however has not previously connected that second- or third-party behavior to the legal device status of the device owner.

This in my view is particularly interesting in regard to offshore contract sterilizers working for offshore contract manufacturers, who are third parties to the device owner and therefore one step removed from the device owner's direct control. Such control of course always has been required for sterilization validation, process-performance verification and certain logistics operations related to not mixing up non-sterile and sterile devices. Until now, though, the second- and third-party Listing requirement has been regarded by the industry, I think, as one that would get the second or third party in trouble...not the device owner.
 

Ronen E

Problem Solver
Moderator
I wonder how it settles with the FD&C act and with the regulations. After all, it is a guidance. I'm sure that as far as the FDA is concerned "guidance" reflects what they expect to see, I just wonder whether that approach is legally enforceable (i.e. would hold in a court appeal etc.). Were the legal instruments amended in any way?
 

Ajit Basrur

Leader
Admin
For the Contract Manufacturer, when the device is listed in FURLS, it is required to link to the customer's product details like 510(K) and Product Code.
 
M

MIREGMGR

I wonder how it settles with the FD&C act and with the regulations. After all, it is a guidance. I'm sure that as far as the FDA is concerned "guidance" reflects what they expect to see, I just wonder whether that approach is legally enforceable (i.e. would hold in a court appeal etc.). Were the legal instruments amended in any way?

In USA, the relevant laws have long been interpreted by high level courts to provide FDA and other executive-branch agencies the latitude to define rules as needed for implementation of the laws for which that agency is responsible. The powers of executive agencies are a much broader area of law than just FDA, and are well settled at the constitutional level. FDA's Guidances in general have this legally-acknowledged-rule status once finalized, depending on the specific language used in the Guidance.

In any case, in practice, FDA rarely if ever directly cites for failure to implement a Guidance...for instance, in a Warning Letter or a request for injunction. Instead they cite for "misbranding" or one of the other broadly defined violations in the FDC Act.
 
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