Aaron Liang I think the instructions for completing FDA Form 3500A you have is the most current, it is the one that my organization was referencing for MDR prior to eMDR. From my understanding block B4 should be the date that the report is filed by the initial reporter as referenced in 21 CFR 803.52(b)(b4) and indicated as such in the instructions.

In Comment G, Section III of the Final Rule of the MDR: Electronic Submission Requirements the FDA has clarified in their response to the comment as "The date received by you is the date that you become aware of the event, which is also reported elsewhere on Form FDA 3500A. We are asking for the “Date of this report” to provide the reporting entity with a means of documenting the date that the MDR is submitted to FDA. This change will make the information requested for device reports consistent with the information recorded by other Centers for products that are reported using the Form FDA 3500A."

From this it is clear to me that "the date received by you" or the awareness date is a separate entry on Form FDA 3500A (specifically block G4 as per 21 CFR 803.52(e)(4)). This is separate from the date that the manufacturer submits this report to the FDA which is documented in block B4.

Hope this makes sense.

Steve Edwards Joanne, I apologize. The links I provided blended together and looked like one. Here they are again.

Instructions for 3500A. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM295636.pdf and the

Federal Register
https://www.federalregister.gov/articles/2014/02/14/2014-03279/medical-device-reporting-electronic-submission-requirements#table_of_contents

Hopefully, they come out distinct this time.

Steve Edwards Aaron, Thank you for your comment. I agree with what you are saying for Comment G. Per Comment G, B4 should represent the Date Sent. However, these are the specific words from the Instructions for FDA Form 3500A, referring to Block B4.

“For all mandatory Medical Device reports, enter the date the initial reporter provided the information about the event (i.e. the first person or entity who initially provided information to the user facility, manufacturer or importer).”

Are you saying that you interpret this to mean that this is the date the reporter submitted the information to the FDA? If so, why would the example include the statement about the person or entity providing information to the mfg? I would think that if B4 was to contain the date sent to FDA, the example would say something like ... information to the FDA. Thoughts?

Aaron Liang Yes, you are right in that this is a conflicting statement. From those instructions it seems like they want field B4 for MDR's to refer to the awareness date. I guess that would make sense since the MDR reporting clock begins as soon as a representative of the manufacturer becomes aware. This would differentiate it from field G4 since unless reported directly from the source to the manufacturer there is likely a lag between the awareness date and the date a manufacturer receives the information. Also, if field B4 implies the awareness date then it would be an easy well for them to check if the report is late?

Danny Nguyen, RAC Hello all,

In my experience here is my take with the two sections on the 3500A form. Section B4 is the aware date of the event. Section G4 is the date the manufacturer was made aware of an event that now makes it reportable. In most cases, these dates would be the same on the 3500A form; however there can be variations depending on the nature of the complaint. If you have an upgrade to reportability, whether it's from additional information from the customer or from returned device evaluation findings, then you add that new aware date to Section G4.

Here is an example. The patient underwent a routine transplant procedure with no indication of a problem problem; however the returned device evaluation finding identified an issue that would now make it reportable. You would still mention the original B4 date in your 3500A report (aware date of the routine transplant) but in G4 you mention the second aware date (the aware date that now makes it reportable). I hope this makes sense. Thanks.

Danny Nguyen, RAC Also just to add that the regulatory clock is dependent on the date in Section G4.

believe Aaron is correct in his first post: B4 should be the date the report is submitted to the FDA, whereas G4 should be the manufacturer’s awareness date.

Quoting the FDA response to the comment on the new rule: “We are asking for the ‘Date of this report’ to provide the reporting entity with a means of documenting the date that the MDR is submitted to FDA.”

The current language of 803.53(b)(4) reads “Date of this report”, not “Date of report by initial reporter” cited here on ecfr.gov

http://www.ecfr.gov/cgi-bin/text-idx?SID=462c5a8959a8729bae0e2bc5215a244a&mc=true&node=se21.8.803_152&rgn=div8

Section (e)(4), representing the entries in the G block, says “Date received by you”.

The language in the general instructions for 3500A document appears to have been published prior to the promulgation of the new rules and the revision to 803.52(b)(4). Notably, the language appearing on the accessdata.fda.gov site seems to be outdated:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=803.52