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Recall vs. Field Correction - Field Corrections instead of a Recall

W

Watchwait

#11
#11
I have exactly the same question. Several of FDAs latest medical device reporting guidelines for manufacturers reference FDA Form 3417 Baseline Reporting. It is to be filled out within 30 days of submitting your first MDR for that product type. But the link to the form is broken on FDAs website, and I can find no other source! Converesely, if anyone can point to specific verbiage that stayed this requirement - better yet! But I believe the only thing that has been stayed was the inclusion of "denominator data".

I hae an email into FDA with this question as well.
 
Elsmar Forum Sponsor
A

Al Rosen

Staff member
Super Moderator
#12
#12
Have you tried the fax back system?
WHERE TO OBTAIN MDR FORMS, GUIDANCE DOCUMENTS OR OTHER MDR INFORMATION

CDRH Facts-On-Demand, telephone number 1-800-899-0381 or 301-827-0111. After connecting, follow the recorded instructions. The system allows for one request per call. Enter the shelf number of choice from the list below followed by the # (pound) sign and continue with the programmed prompts.

MDR DOCUMENTS FROM FACTS-ON-DEMAND SYSTEM

SHELF NO. -- TITLE
336# -- Final MDR Regulation, published 12/11/95
407# -- Baseline Report, FDA Form 3417
409# -- User Facility Annual Report, FDA Form 3419
799# -- MDR Related Documents Information
853# -- Instructions and Coding Manual for MedWatch 3500A, 77 pages 854# MedWatch, FDA Form 3500A
1061# -- Instructions for completing FDA Form 3417, Baseline Report
1096# -- Stay of effective date for denominator data on Baseline Report
1336# -- Amendment to final rule, Federal Register, 4/11/96
1853# -- Coding Manual Addendum
Click to expand...
 
M

MadameISO

#13
#13
Hello to all,

This is my first post!

I also have been looking for form F-3417 on FDA's website. I contacted FDA about it today and was told the baseline report requirement has been removed from 21 CFR 803.

The removal is formally documented in the Federal Register (Vol. 73 No. 115 of 2008-06-13 (page 33692) and No. 181 of 2009-09-17 (page 53686)).
A websearch for E8-13350.pdf and E8-21756.pdf will find the documents.

Best regards.
 
R

robert.beck

Involved In Discussions
#14
#14
Re: Recall vs field correction

Is it possible to get some clarification on the difference between a stock recovery and a market withdrawal?

I have a situation where a few units were shipped to a distributor. After they got there, we found a calibration problem that may pose a slight health risk, but we're not sure. The device has two redundant safety systems, and the primary system is improperly calibrated but the secondary system is ok. The units are still in the distributor's warehouse. We will get them back and fix them. What is this is? A stock recovery or a market withdrawal?

The problem with the latter is that this is not "routine." The problem with the former is that we released them to the distributor, even though they haven't gone to their final destination yet. In other words, from our perpsective they've been released, but from the distributor's perspective, they have not been sold.
 
M

MIREGMGR

#15
#15
Re: Recall vs field correction

robert.beck said:
Is it possible to get some clarification on the difference between a stock recovery and a market withdrawal?

I have a situation where a few units were shipped to a distributor. After they got there, we found a calibration problem that may pose a slight health risk, but we're not sure. The device has two redundant safety systems, and the primary system is improperly calibrated but the secondary system is ok. The units are still in the distributor's warehouse. We will get them back and fix them. What is this is? A stock recovery or a market withdrawal?

The problem with the latter is that this is not "routine." The problem with the former is that we released them to the distributor, even though they haven't gone to their final destination yet. In other words, from our perpsective they've been released, but from the distributor's perspective, they have not been sold.
Click to expand...
My take is that your situation is a Removal, not a Stock Recovery or a Market Withdrawal. Your district's Recall Coordinator should be consulted to determine if it should be a Recall, i.e. Class III, but I'd doubt that since no units have reached end users.
 
Y

yana prus

#17
#17
Re: Recall vs field correction

Hi All,

There is a new draft FDA guidance Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for
http :// www .fda. gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm340518.htm?source=govdelivery - DEAD 404 LINK UNLINKED

This guidance introduces a new term: Product Enhancement - change or improvement to a non-violative device as part of continuous device improvement activities. Product enhancements include, but are not limited to, changes designed to better meet the needs of the user, changes to make the product easier to manufacture, and changes to the appearance of the device that do not affect its use. A product enhancement is both (1) a change to improve the performance or quality of a device, and (2) not a change to remedy a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321 et seq.] caused by the device. A product enhancement is not a medical device recall.

Other terms are further detailed as well:
Correction means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location (21 CFR 7.3(h) and 21 CFR 806.2(d)). Depending on the circumstances involved, a correction can be a recall or product enhancement.
Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. (21 CFR 806.2(i)). Depending on the circumstances involved, a removal can be a recall or product enhancement.
 
Last edited by a moderator:
R

robert.beck

Involved In Discussions
#18
#18
Re: Recall vs field correction

looks like this is a REMOVAL. wish it were easier to tell when a removal was a recall. in this case, no devices were placed in service, but some got as far as a distributor warehouse.
 
R

robert.beck

Involved In Discussions
#19
#19
Here is an interesting situation related to field corrections: when a patient calls the help desk with a problem, it is often easier and faster to ship them a new device than walk them through a fix to the problem. the device is question is low risk monitor, not diagnostic not does it deliver any therapy. Often the problem is a user error but technically, these are complaints, and also technically these are correction recalls because the original device is replaced. After reading many FDA guidance documents, the strict conclusion is to report every one of these with an HHE. Treating these minor problems as recalls means sending FDA a lot of HHEs. Is there a better way to deal with this? All of the calls and the resultant actions are documented.

There is a second part to this situation. When the company determines that the problem is software-related, it reacts by generating a hotfix and sending those out to all devices in the field over the cellular network. These are clearly "corrections." Is there some way to justify not reporting these since 99% will be class III?
 
Sam Lazzara

Sam Lazzara

Trusted Information Resource
#20
#20
Hello Robert,
Interesting situation.

The actions you describe would not be considered a "Recall" per FDA regulations 21 CFR Part 7 or Part 810, since only FDA can determine that a Correction or Removal is a FDA Recall.

Regarding reportability of corrections or removals to FDA per 21 CFR Part 806....reports to FDA are required if the Correction/Removal is initiated to reduce a risk to health. You need to document a Health Hazard Evaluation (HHE) to make that determination.

When you replace the existing device with a new device, do you ask the customer to return the existing device?
If Yes, that would be a removal.
If No, your replacement action does not directly meet the definition for a Correction or Removal.

§806.10 Reports of corrections and removals.
(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:

(1) To reduce a risk to health posed by the device; or

(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under §806.1(b).

Regarding the "hotfix", the same requirements apply. You should document a HHE for the hotfix Correction, and if it meets FDA reportability criteria then you should report it to FDA.

You may find the attached presentation useful.
 

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