What is Form 3500 of the FDA?

June 17, 2011 - PRLog -- The FDA, in an ongoing commitment to human safety, has made available a simple process for
submitting reports on adverse events. The Form 3500 is available online at
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm085568.htm and can be used by patients and
medical practitioners to submit reports of untoward reactions to FDA-approved medical products.
Form FDA 3500 can be used to report adverse events, errors with the quality or manufacture of
products related to:
1. Medicines/drugs
2. Biologics (blood components, blood derivatives, allergenic substances, human cells, tissues
and cellular and tissue-based products)
3. Medical Devices
4. Dietary supplements, infant formulae and medical foods
5. Cosmetics
The Importance of FDA 3500
The FDA gives extreme importance to reports submitted, and in fact encourages voluntary
submission of the form in the interest of human safety. The reports thus submitted are carefully
evaluated by the FDA and become the basis for crucial decision making processes.
During adverse events, when a patient is critically ill, it is not really possible for the patient to file Form
3500. The onus to submit a report rests with the patient’s relatives or healthcare professionals to
ensure that the form is submitted in the interest of saving human lives.
Description of Form 3500
Form 3500 has several sections and they are described briefly herewith:
Section A relates to information about the patient, i.e. patient’s name, age, etc.
Section B relates to the adverse event, error or product problem.
Section C is a simple question on whether the product is available for evaluation. It is important to
note that the box needs to be ticked if the product is available, but the product itself should not be
sent to FDA at this stage.
Section D gives the option to mention two suspect drugs which could have caused the event, problem
or error.
Section E is limited to medical devices and this column should be filled in when reporting events
related only to medical devices.
Section F takes into account other products which may have caused the event, and information
related to the same can be included here.
Section G captures information on the reporter or the volunteer who has filled in the form.
Confidentiality terms highlighted in the form ensure total safety for the volunteer;
Submitting Form 3500
The Form can be submitted online at: https://www.accessdata.fda.gov/scripts/medwatch/medwatcho....
htm. To ensure security and safety of online submissions the website is protected by Secure
Socket Layers (SSL) and Pretty Good Protection (PGP). Java script needs to be enabled when
submitting the form.
As a user friendly process, the form has guidelines to help in filling in the required fields. Once
completed, a copy of the form can be printed out.
As attachments cannot be included when submitting the form, volunteers can `cut and paste’ relevant
data in appropriate spaces provided in the form.
The form can be submitted even if the person is not completely sure whether the cause of death is an
adverse event related to a medical product or device.
How to report:
• Fill in the sections that are applicable.
• Section D needs to be used for all products other than medical devices.
• Separate forms to be submitted for individual patients.
• The report can be faxed to: 1-800-FDA-0178 or by phone to 1-800-1088.
• The form can also be submitted online at: www.fda.gov/medwatch/report.htm.
References:
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/...
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadFo...

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