Entering and Reviewing Data for 3500A Reports
When you populate a regulatory report, many fields are copied from the product issue record. When you edit these fields in the regulatory report record, the edits are not copied back to the product issue record.
This task is a step in Process of Regulatory Reporting.
To review and enter data for the 3500A report
Navigate to Regulatory Reports screen, then the Regulatory Report List view.
In the Regulatory Report List, drill down on a 3500A regulatory report record.
Review and if necessary modify the information in the More Info and Patient views.
If you are a manufacturer:
Make sure that the Facility Type field in the Importer view is blank. By default, this field is set to blank.
Complete the fields in the Manufacturer view.
These fields populate section G of the 3500A form. Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.
Field Comments Mapping to 3500A Form (A)NDA #
The abbreviated new drug application or the new drug application number.
This field is automatically populated if there is an (A)NDA number associated with the protocol site.
G5
10-day
Select the check box to indicate the report is a 10-day report.
G7
15-day
For reports of serious and unexpected adverse events.
G7
5-day
For events requiring remedial action to prevent unreasonable risk to public health, or where written notice is required.
G7
Address
Manufacturer contact office address - Street.
G1
AE Terms
List of adverse event terms that most accurately characterize the adverse event described in Event Detail section.
G8
City
Manufacturer contact office address - City.
G1
Consumer
Report Source is the consumer or treating health care provider.
G3
Contact Name
Manufacturer contact’s last name.
G1
Contact Office
Manufacturer’s contact office.
G1
Country
Manufacturer contact office address - Country.
G1
Distributor
Check this if report was received from the distributor (importer) of the suspect product.
G3
First Name
Manufacturer contact’s first name.
G1
Follow-up
Check if the report is a follow-up to a previously submitted report.
G7
Follow-Up #
Follow-up sequence number.
G7
Foreign
Report Source is a foreign source (for example, foreign medical facility, affiliate, or government).
G3
IND #
The investigational new drug (IND) application number.
This field is automatically populated if there is an IND number associated with the protocol site.
G5
Initial
Check if the report is the first submission of a manufacturer report (30 day report for device).
G7
Literature
Report Source is the scientific literature or an unpublished manuscript.
G3
Mfg Report #
Regulatory report number.
G9
OTC Product
Check if the suspect medication can be purchased over-the-counter (without a prescription).
G5
Other
Report Source is any source not covered by the previous categories.
G3
Periodic
For reports of serious labeled and non-serious (labeled and unlabeled) adverse events.
G7
Phone #
Manufacturer contact’s work phone number.
G2
PI Received
The date when a company representative became aware of the event.
G4
Postal Code
Manufacturer contact office address - Postal Code.
G1
Pre-1938
Check the box if the suspect medication was marketed prior to 1938 and does not have an NDA #.
G5
Products
Product(s) involved in the event.
Professional
Report Source is a physician, pharmacist, nurse, and so on.
G3
Protocol #
Protocol number identifies the clinical trial at a site. If regulatory report is an IND safety report, enter the protocol number.
G6
Received Report #
Report number for the MedWatch form received from a Importer or a User Facility.
MedWatch Header
Representative
Check this if a company representative reported the event based on information from a health professional.
G3
State
Manufacturer contact office address - State.
G1
Study
Report Source is a postmarketing, clinical trial, surveillance, or other study.
G3
User Facility
Check this if the manufacturer received the report from the MDR contact in a user facility as identified in section F.
G3
If you are a device manufacturer, complete the fields in the Investigation view.
These fields populate section H of the 3500A form. Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.
Field Comments Mapping to 3500A Form Evaluation
If an evaluation was conducted, note summary here and choose Evaluation Summary Attached in Evaluated by Mfg Field.
H3
Death
Check only if the death was an outcome of the adverse event.
H1
Correction
Do not check when creating an initial report.
Follow-up with changes to previously submitted information.
H2
Serious Injury
Event is life-threatening, results in permanent impairment, requires intervention to prevent permanent impairment.
H1
Additional Information
Do not check when creating an initial report.
Information concerning the event that was not provided in the initial report.
H2
Malfunction
Device malfunctions.
H1
Response to FDA Request
Do not check when creating an initial report.
Additional information requested by FDA concerning the device/event.
H2
Other
Event not covered by death, serious injury, or malfunction. This type of category should be rarely used.
H1
Device Evaluation
Do not check when creating an initial report.
Evaluation/analysis of device.
H2
Mfg Narrative
Any additional information, evaluation, or clarification of data presented in previous sections.
H10
Recall
Remedial Action - Recall.
H7
Method Codes
Method codes capture two items — the source of the device that was evaluated and the type of evaluation performed.
Do not enter more than four codes.
H6
Repair
Remedial Action - Repair.
H7
Result Codes
Describes the results of evaluation and analyses of the reported device problem(s).
Do not enter more than four codes.
H6
Replace
Remedial Action - Replace.
H7
Conclusion Codes
Describes the evaluation conclusions.
Do not enter more than four codes.
H6
Relabeling
Remedial Action - Relabeling.
H7
Evaluated by Mfg
If you do not check this box, then you should complete the Non-Evaluation Codes field.
Identify if the device was evaluated.
H3
Notification
Remedial Action - Notification.
H7
Non-Evaluation Codes
If an evaluation of a returned medical device was NOT conducted, provide the appropriate code.
H3
Corrected Data
Additional, corrected, or missing information, identifying each data item by the applicable section and block number.
H11
Inspection
Remedial Action - Inspection.
H7
Usage of Device
Indicates whether the use of the suspect medical device was the initial use, reuse, or unknown.
H8
Patient Monitoring
Remedial Action - Patient monitoring.
H7
Mfg Date
Month and year of manufacture of the suspect medical device.
This field can be based on asset number (asset manufacture date) or lot number (effective start date).
H4
Modification
Remedial Action - Modification.
H7
Labeled Single Use
Indicates whether the device was labeled for single use.
H5
Other
Remedial Action - Other - Specify the type of action in this field.
H7
Correction #
If action reported to FDA under 21 USC 360i(f), list correction or removal reporting number.
H9
If you are a user facility or importer, complete the fields in the Importer view.
These fields populate section F of the form. Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.
Field Comments Mapping to 3500A Form Facility Type
Indicate whether the report is from a user facility, importer, or others.
F1
Importer
Name of the distributor or importer.
F3
Contact Name
Last name of the distributor’s or importer’s representative to contact regarding the event.
F4
Device Age
The approximate age of the device.
F9
Report #
Regulatory report # for this report, which is being submitted by an importer.
This number is auto-populated when the report is generated.
F2
Address
Distributor’s or Importer’s address - Street Address line #1.
This field is auto-populated based on the distributor’s or importer’s name.
F3
First Name
First name of the distributor’s or importer’s representative to contact regarding the event.
F4
Age UoM
Unit of measurement for device age.
F9
Report Type
Indicates if the report to the regulatory agency will be an initial or follow-up report.
F7
City
Distributor’s or importer’s address - City.
F3
Phone #
Contact’s work phone number.
F5
Patient Codes
Patient codes describe what happened to the patient as a result of the event.
Do not enter more than three codes.
F10
Follow-up #
Sequence number of the follow-up report.
F7
Postal Code
Distributor’s or importer’s address - Postal Code.
F3
Reported FDA
Indicates if the distributor or importer has already sent a report to the regulatory agency.
F11
Device Codes
Device codes describe device failures or problems encountered during the event.
Do not enter more than four codes.
F10
Reported Mfg
Indicates if the distributor or importer has sent a report to the manufacturer.
F13
State
Distributor’s or importer’s address - State.
F3
FDA Report Date
Date the report was sent to the regulator agency.
F11
Event Location
Location of the actual occurrence of the event.
F12
Mfg Report Date
Date the report was sent to the manufacturer.
F13
Country
Distributor’s or importer’s address - Country.
F3
PI Received
The date when a company representative became aware of the event.
F6