Form Fda 3500B – Fill Out and Use This PDF

The Form FDA 3500B is designed for consumers to voluntarily report adverse effects and product problems related to drugs, medical devices, and other FDA-regulated products directly to the FDA. This critical reporting mechanism helps monitor product safety, enhancing public health protections. If you've experienced a problem with any FDA-regulated product, you are encouraged to provide as much detail as possible using this form. For step-by-step assistance with filling out Form FDA 3500B, click the button below.

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Form Fda 3500B PDF Details

In today's highly regulated healthcare environment, the importance of vigilance in reporting adverse events cannot be overstated. The FDA 3500B form serves as a critical tool in this regard, designed specifically for consumer voluntary reporting of issues related to drugs, medical devices, and other products regulated by the U.S. Food and Drug Administration (FDA). Aimed at enabling consumers to report any harmful effects, quality problems, or erroneous usage which could lead to unsafe situations, this form facilitates a direct channel of communication between the public and the FDA. It covers a broad spectrum of products, including but not limited to prescription medicines, over-the-counter (OTC) drugs, biologics, nutritional products, cosmetics, and foods, highlighting the FDA's comprehensive approach to monitoring post-market product safety. However, it notably excludes vaccines and investigational drugs or devices, which are subjected to separate reporting mechanisms. The form is designed with privacy in mind, ensuring that the identity of the reporter is protected, though it allows for the sharing of information with the product's manufacturer to promote better understanding and resolution of the reported issue. Completing the form is streamlined for ease of use, encouraging reporters to provide as much detail as possible without the requirement of having all information at hand. Furthermore, the FDA assures reporters of confidentiality and a commitment to utilize the reports for safety evaluation purposes, demonstrating a structured effort to safeguard public health based on consumer feedback. For those seeking to make a report, the FDA has made accessible various channels, including a toll-free number and an online reporting platform, underscoring the agency's dedication to accessibility and consumer engagement in monitoring and improving the safety of healthcare products.

Question	Answer
Form Name	Form Fda 3500B
Form Length	5 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	1 min 15 sec
Other names	3500B, fda form 3500b, fda 3500, form 3500b editable

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

MEDWATCH Consumer Voluntary Reporting

(FORM FDA 3500B)

Form Approved: OMB No. 0910-0291 Expiration Date: 6/30/2015

(See PRA Statement below)

When do I use this form?

•You were hurt or had a bad side effect (including new or worsening symptoms) after taking a drug or using a medical device or product.

•You used a drug, product, or medical device incorrectly which could have or led to unsafe use.

•You noticed a problem with the quality of the drug, product, or medical device.

•You had problems with how a drug worked after switching from one maker to another maker.

•Medical devices, including any health-related kit, test, tool, or piece of equipment (such as breast implants, pacemakers, diabetes glucose-test kits, hearing aids, breast pumps, and many others)

•Nutrition products, including vitamins and minerals, herbal remedies, infant formulas, and medical foods, such as those labeled for people with a specific disease or condition

•Cosmetics or make-up products

•Foods (including beverages and ingredients added to foods)

Don’t use this form to report:

•Vaccines – report problems to the Vaccine Adverse Event Reporting System (VAERS)

•Investigational drugs or medical devices (those being studied, not yet approved) – report problems to your doctor or to the contact person listed in the clinical trial

Will the information I report be kept private?

The FDA recognizes that privacy is an important concern, so you should know:

•We ask only for the name and contact information of the person filling out the form in case we need more information. This information will not be given out to the public.

•Information about the problem may be shared with the company that makes the product to help them better understand the problem you are reporting, unless you request otherwise (see Section E).

Are there specific instructions for filling out the form?

•Fill in as much information as possible and send in the report even if you do not have all the information.

•You can fill out this form yourself or have someone fill it out for you. If you need help, you may want to talk with your health professional.

•Feel free to include or attach an image. Please do not send the products to the FDA.

How will I know the FDA has received my form?

•You will receive a reply from the FDA after we receive your report. We will personally contact you only if we need additional information.

•Your report will become part of a database so that it can be reviewed and compared to other reports by an FDA safety evaluator who will determine what steps to take.

What types of products should I use this form for?

•Drugs, including prescription or over-the-counter medicines, and biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments, and bone) and gene therapies

How can I contact the FDA if I have questions?

Toll-free line: 1-800-332-1088

www.fda.gov/reportinghelp

To report online: www.fda.gov/medwatch/report.htm

The information below applies only to requirements of the Paperwork Reduction Act of 1995.

The burden time for this collection of information is estimated to average 25 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to the address to the right:

OMB Statement: “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

DO NOT SEND YOUR COMPLETED FORM TO THIS PRA STAFF EMAIL ADDRESS.

FORM FDA 3500B (4/13)

MEDWATCH Consumer Voluntary Reporting

General Information Page

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

MEDWATCH Consumer Voluntary Reporting

(FORM FDA 3500B)

Form Approved: OMB No. 0910-0291 Expiration Date: 6/30/2015

(See PRA Statement on preceding general information page)

Section A – About the Problem

What kind of problem was it? (Check all that apply)

Were hurt or had a bad side effect (including new or worsening symptoms)

Used a product incorrectly which could have or led to a problem

Noticed a problem with the quality of the product

Had problems after switching from one product maker to another maker

Did any of the following happen? (Check all that apply)

Hospitalization – admitted or stayed longer

Required help to prevent permanent harm (for medical devices only)

Disability or health problem

Birth defect

Life-threatening

Death (Include date):

Other serious/important medical incident (Please describe below)

Date the problem occurred (mm/dd/yyyy)

Tell us what happened and how it happened. (Include as many details as possible)

List any relevant tests or laboratory data if you know them. (Include dates)

For a problem with a product, including
•	prescription or over-the-counter medicine	
•	biologics, such as human cells and tissues used for transplantation
	(for example, tendons, ligaments, and bone) and gene therapies		Go to Section B
•	nutrition products, such as vitamins and minerals, herbal remedies, infant
	formulas, and medical foods
•	cosmetics or make-up products
•	foods (including beverages and ingredients added to foods)

For a problem with a medical device, including
•	any health-related test, tool, or piece of equipment
•	health-related kits, such as glucose monitoring kits or blood pressure cuffs		Go to Section C
•		 (Skip Section B)
•	implants, such as breast implants, pacemakers, or catheters	 (Skip Section B)

•other consumer health products, such as contact lenses, hearing aids, and breast pumps

For more information, visit http://www.fda.gov/MedWatch

Submission of a report does not constitute an admission that medical

personnel or the product caused or contributed to the event.

FORM FDA 3500B (4/13)

MEDWATCH Consumer Voluntary Reporting

Page 1 of 3

Section B – About the Products

Name of the product as it appears on the box, bottle, or package (Include as many names as you see)

Name of the company that makes the product

Expiration date (mm/dd/yyyy)

Lot number

NDC number

Strength (for example,		Quantity (for example, 2 pills,			Frequency (for example,		How was it taken or used (for example,
250 mg per 500 mL or 1 g)		2 puffs, or 1 teaspoon, etc.)			twice daily or at bedtime)		by mouth, by injection, or on the skin)?

Date the person first started taking					Why was the person using the product (such as, what condition was it
or using the product (mm/dd/yyyy):					supposed to treat?)
Date the person stopped taking or
using the product (mm/dd/yyyy):
using the product (mm/dd/yyyy):


Did the problem stop after the
Did the problem stop after the
person reduced the dose or stopped			Yes	No
taking or using the product?			Yes	No
taking or using the product?

Did the problem return if the person started taking or using					Do you still have the product in case we need to evaluate it? (Do not
the product again?					send the product to FDA. We will contact you directly if we need it.)
Yes	No		Didn’t restart			Yes	No

Go to Section D (Skip Section C)

Section C – About the Medical Device

Name of medical device

Name of the company that makes the medical device

Other identifying information (The model, catalog, lot, serial, or UDI number, and the expiration date, if you can locate them)

Was someone operating the medical device when the problem occurred?

Yes

If yes, who was using it?

The person who had the problem

A health professional (such as a doctor, nurse, or aide)

Someone else (Please explain who)

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.)

Date the implant was put in (mm/dd/yyyy)

Date the implant was taken out (If relevant) (mm/dd/yyyy)

Go to Section D

For more information, visit http://www.fda.gov/MedWatch

Submission of a report does not constitute an admission that medical

personnel or the product caused or contributed to the event.

FORM FDA 3500B (4/13)

MEDWATCH Consumer Voluntary Reporting

Page 2 of 3

Section D – About the Person Who Had the Problem

Person’s Initials	Sex	Age (at time the problem	Weight (Specify	Race
	Female	occurred) or Birth Date	lbs or kg)
	Male

List known medical conditions (such as diabetes, high blood pressure, cancer, heart disease, or others)

Please list all allergies (such as to drugs, foods, pollen, or others).

List any other important information about the person (such as smoking, pregnancy, alcohol use, etc.)

List all current prescription medications and medical devices being used.

List all over-the-counter medications and any vitamins, minerals, supplements, and herbal remedies being used.

 Go to Section E

Section E – About the Person Filling Out This Form

We will contact you only if we need additional information. Your name will not be given out to the public.

Last name

First name

Number/Street

City and State/Province

Country

ZIP or Postal code

Telephone number

Email address

Today’s date (mm/dd/yyyy)

Did you report this problem to the company that makes the product (the manufacturer)?

Yes No

May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the

product?	Yes	No

Send This Report by Mail or Fax

Keep the product in case the FDA wants to contact you for more information. Please do not send products to the FDA. Mail or fax the form to:

Mail:

MedWatch

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Fax:

1-800-332-0178 (toll-free)

Thank you for helping us protect the public health.

For more information, visit http://www.fda.gov/MedWatch

Submission of a report does not constitute an admission that medical

personnel or the product caused or contributed to the event.

FORM FDA 3500B (4/13)

MEDWATCH Consumer Voluntary Reporting

Page 3 of 3

Continued Entries

CONTINUED ENTRY FOR: Tell us what happened and how it happened. (Include as many details as possible)

CONTINUED ENTRY FOR: List any relevant tests or laboratory data if you know them. (Include dates)

CONTINUED ENTRY FOR: List all current prescription medications and medical devices being used.

CONTINUED ENTRY FOR: List all over-the-counter medications and any vitamins, minerals, and herbal remedies being used.

FORM FDA 3500B (4/13)

MEDWATCH – Consumer Voluntary Reporting

Continuation Page

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Step 1: Click the "Get Form" button at the top of this webpage to open our editor.

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Completing this document requires thoroughness. Ensure each and every field is completed properly.

1. The 3500B usually requires particular information to be entered. Be sure the subsequent blank fields are completed:

2. The third step is usually to complete the following fields: For a problem with a product, prescription or overthecounter, for example tendons ligaments and, nutrition products such as, formulas and medical foods, cosmetics or makeup products, foods including beverages and, Go to Section B, For a problem with a medical, any healthrelated test tool or, and Go to Section C Skip Section B.

3. This third segment should also be rather straightforward, Name of the product as it appears, Name of the company that makes the, Expiration date mmddyyyy, Lot number, NDC number, Strength for example mg per mL, Quantity for example pills puffs, Frequency for example twice daily, How was it taken or used for, Date the person first started, Date the person stopped taking or, Did the problem stop after the, Yes, Why was the person using the, and Did the problem return if the - each one of these empty fields will have to be completed here.

People who work with this form frequently make some mistakes while filling out Yes in this section. Remember to re-examine what you type in right here.

4. To go forward, the next section requires filling out several form blanks. Included in these are Name of medical device, Name of the company that makes the, Other identifying information The, Was someone operating the medical, If yes who was using it, The person who had the problem, Yes, A health professional such as a, Someone else Please explain who, For implanted medical devices ONLY, Date the implant was put in, and Date the implant was taken out If, which are integral to carrying on with this form.

5. When you near the final sections of your file, you will find a couple extra requirements that must be fulfilled. In particular, Section D About the Person Who, Persons Initials, Sex, Female, Male, Age at time the problem occurred, Weight Specify lbs or kg, Race, List known medical conditions such, Please list all allergies such as, List any other important, List all current prescription, List all overthecounter, Go to Section E, and We will contact you only if we should all be done.

Step 3: After rereading your fields you've filled out, press "Done" and you're done and dusted! Make a free trial option at FormsPal and gain immediate access to 3500B - download or edit in your FormsPal cabinet. FormsPal is committed to the confidentiality of our users; we ensure that all personal data put into our editor stays confidential.

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