Get the up-to-date medwatch 3500a 2024 now

Show details

4.3 out of 5

55 votes

The following specific information is to be incorporated Include the phrase continued at the end of each field of FDA Form 3500A that has additional information continued onto another page Section G All manufacturers may be substituted for section D Suspect medical device on the front of the form to enable the submission of a one page form If section G is reproduced on the front of the form it must be an identical reproduction of the original section G All submissions must be made in English ...

Here's how it works

01. Edit your medwatch form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send medwatch via email, link, or fax. You can also download it, export it or print it out.

The best way to modify Medwatch 3500a in PDF format online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Adjusting documents with our comprehensive and intuitive PDF editor is simple. Make the steps below to fill out Medwatch 3500a online easily and quickly:

Sign in to your account. Log in with your email and password or create a free account to test the product before choosing the subscription.
Import a form. Drag and drop the file from your device or import it from other services, like Google Drive, OneDrive, Dropbox, or an external link.
Edit Medwatch 3500a. Effortlessly add and highlight text, insert pictures, checkmarks, and icons, drop new fillable fields, and rearrange or remove pages from your document.
Get the Medwatch 3500a completed. Download your adjusted document, export it to the cloud, print it from the editor, or share it with others via a Shareable link or as an email attachment.

Take advantage of DocHub, one of the most easy-to-use editors to promptly manage your paperwork online!

See more medwatch 3500a versions

We've got more versions of the medwatch 3500a form. Select the right medwatch 3500a version from the list and start editing it straight away!

Versions	Form popularity	Fillable & printable
2022	4.2 Satisfied (31 Votes)
2019	4.9 Satisfied (52 Votes)
2015	4.8 Satisfied (50 Votes)
2009	4.3 Satisfied (55 Votes)
2003	4.9 Satisfied (49 Votes)

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

Where do I send my FDA Form 3500A?

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

What are MDR reportable events?

An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

What should I not report to MedWatch?

What Not to Report to FDA MedWatch: Tobacco product problems. Vaccines. Investigational (study) drugs. Mandatory reporting required by regulated industries (Drugs and Biologics, Devices) Dietary Supplements. Veterinary Medicine Products.

When should a MedWatch form be submitted to the FDA?

User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

Where do I send my FDA Form 3500A?

form 3500a

medwatch 3500a instructions medwatch form 3500a download fda form 3500 vs 3500a fda 3500a pdf fda form 3500b fda adverse event reporting form when should a medwatch form be submitted to the fda? sample medwatch form

Related forms

be ready to get more

Complete this form in 5 minutes or less

Get form

What is the purpose of the MedWatch?

The FDA developed MedWatch to provide important safety information to consumers and to allow consumers to report serious problems with human medical products.

What should be reported to the FDA?

Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. (Key terms are defined in 21 CFR 803.3.) Instructions are available for completing the required 3500A form.

When should a MedWatch form be submitted to the FDA?

Device User Facility Reporting Requirements User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

What gets reported to MedWatch?

MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines. Biologics such as blood components, blood/plasma derivatives and gene therapies. Medical devices such as hearing aids breast pumps, and pacemakers.

What does MedWatch stand for?

MedWatch is the Food and Drug Administration's \u201cSafety Information and Adverse Event Reporting Program.\u201d It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event.

Get the up-to-date medwatch 3500a 2024 now

Here's how it works

The best way to modify Medwatch 3500a in PDF format online

See more medwatch 3500a versions

Complete this form in 5 minutes or less

Got questions?

Where do I send my FDA Form 3500A?

What are MDR reportable events?

What should I not report to MedWatch?

When should a MedWatch form be submitted to the FDA?

Where do I send my FDA Form 3500A?

Complete this form in 5 minutes or less

People also ask

What is the purpose of the MedWatch?

What should be reported to the FDA?

When should a MedWatch form be submitted to the FDA?

What gets reported to MedWatch?

What does MedWatch stand for?

3500a

Try more PDF tools