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U.S. Agents - Responsibility for reporting adverse events to the FDA

QAMed26

Starting to get Involved
#1
Good morning fellow Cove-ers

We are a Canadian medical device company who currently uses a U.S Agent as required for any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States.

Upon review of our contract with our agent, it says “Please note that the U.S. Agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803) or submitting510(k) Premarket Notifications (21 CFR Part 807, Subpart E”
This is in line with what is stated on the FDA website U.S. Agents

However, 21 CFR 803.50 states:
Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with §807.40 of this chapter. The U.S. designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of this regulation, foreign manufacturers shall inform FDA, by letter, of the name and address of the U.S. agent designated under this section and §807.40 of this chapter, and shall update this information as necessary. Such updated information shall be submitted to FDA, within 5 days of a change in the designated agent information.
(b) U.S.-designated agents of foreign manufacturers are required to:
(1) Report to FDA in accordance with §803.50, 803.52, 803.53, and 803.56;
(2) Conduct, or obtain from the foreign manufacturer the necessary information regarding, the investigation and evaluation of the event to comport with the requirements of §803.50;
(3) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement;
(4) Maintain complaint files in accordance with §803.18; and
(5) Register, list, and submit premarket notifications in accordance with part 807 of this chapter.

As it is noted that we can only have one U.S agent, how do we go about resolving this apparent contradiction between the U.S. Agent’s responsibilities and 21 CFR 803.50?

My U.S. Agent hasn't responded to my enquiries (which is another issue altogether) so I was hoping someone here could point me in the right direction.

Thanks!!
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
how do we go about resolving this apparent contradiction between the U.S. Agent’s responsibilities and 21 CFR 803.50?
It seems to me that your designated US Agent is risk-adverse and attempting to refuse any responsibility for something that, according to your post, they have to be responsible for. So, the dilemma is that the contract contravenes a regulatory requirement and it creates problems for your organization.

As I see it, the only plausible solution is for the agent to accept the regulatory mandate for the reporting responsibility, or, you find another agent who does.

Good luck.
 

QAMed26

Starting to get Involved
#3
I would agree, however the text in their contract is taken word for word from the FDA website on Responsibilities of a U.S. agent.

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.
The responsibilities of the U.S. agent are limited and include:

- assisting FDA in communications with the foreign establishment,
- responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
- assisting FDA in scheduling inspections of the foreign establishment and
if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

Can the FDA contradict itself?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Can the FDA contradict itself?
I agree with you that it looks like a contradiction and, possibly the best way forward is to ask the FDA themselves.

They list the following communication channels to seek clarifications on this issue:

For Questions about Medical Device Reporting, including interpretation of MDR policy:

Call: (301) 796-6670
Email: [email protected]
 

QAMed26

Starting to get Involved
#5
Re: U.S. Agents - Responsibility for reporting adverse events

:thanx::thanx::thanx:

There are so many different email addresses for the FDA that it is sometimes hard to figure out who to email.

I will do that immediately.

Thanks again!
 
#6
Re: U.S. Agents - Responsibility for reporting adverse events

Thanks QAMed26 for this timely thread. I was just wondering the exact same thing!

My assumption is that, despite 21 CFR 803.50, in practice the US agent is rarely, if ever, contacted. Users would have to look up the US Agent for the company online (without any instruction to do so), as opposed to simply contacting the manufacturer/distributor directly via the contacts required in the labelling as per 21 CFR 801.1.

Hence, the contradiction you've identified is likely almost always a non-issue. In practice, the US Agent is probably nothing more than the occasional go-between between the FDA and the organisation. I note that 21 CFR 803.50 also requires US Agents to maintain complaint files, and submit pre-market notifications. Does this ever happen as required in practice these days?! I'm assuming this is some legacy regulation from times past, that has not been updated because, like I say, it's likely, for the most part, a non-issue in practice.

That's just my assumption, however, and does not excuse the contradiction.

Please post back on this thread when you hear back from the FDA...
I (and probably many others that have the same question) would very much appreciate hearing the FDA's explanation!

MM.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
Re: U.S. Agents - Responsibility for reporting adverse events

By face value it does look like a contradiction.

I have no doubt that in a case of contradiction between the regulation and website (any website) contents, the rgeulation prevails, no matter how old and seemingly archaic.

Please note that the regulation quoted on the FDA website (the actual verbatim regulation text) in not guaranteed to be the latest; you should always check at eCFR.
 

Ajit Basrur

Staff member
Admin
#8
Interesting question. Agree there looks like a contradiction.

QAMed26, please let us know when you hear more on this subject. Thank you!
 

QAMed26

Starting to get Involved
#9
So interestingly enough, I heard back from the FDA twice yesterday (I really had no expectation that I would hear back from them at all).

Their first response was essentially saying they would look into it and then the final response near the end of the day was that the clause I was citing was actually 803.58 not 803.50, and 803.58 was indefinitely stayed in 2014 so there is no contradiction.

So at least I could sleep better last night.

Thanks to all who responded and for pointing me to the right FDA department. I really do enjoy this forum.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#10
This is the bit that was missing in the quote:

Effective Date Note:

At 79 FR 8846, Feb. 14, 2014, part 803 was revised. At 79 FR 8855, Feb. 14, 2014, 803.58 was stayed indefinitely.
It appears both on eCFR and on the FDA website (21 CFR 803).

Does anybody know which court stayed it, and why?
 
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