What is the MedWatch system?

What is the MedWatch system?

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines.

What is the purpose of a MedWatch form?

“A MedWatch Form is used to report an adverse or sentinel event to MedWatch” – the United States Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program. Founded in 1993, the MedWatch program was established by the FDA to help collect data on adverse events in the healthcare industry.

What should be reported to MedWatch?

Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.

What is the difference between Faers and MedWatch?

MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event.

What is MedWatch number?

Thank you for your interest in MedWatch and we look forward to serving your Medical Management needs. You may contact us directly at 800-432-8421, or if you would prefer, please complete our online form and one of our professionals will contact you shortly.

Where can MedWatch be found?

US Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville MD 20857-0001; 888.463. 6332. http://www.fda.gov/medwatch/; free Website.

Who can submit a MedWatch form?

MedWatch for Industry FDA Form 3500A pdf Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel.

Is reporting to MedWatch mandatory?

Mandatory Medical Device Reporting: The regulation specified that reports be filed on the FDA’s Medwatch Form 3500A or an electronic equivalent. 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.

What is MedWatch quizlet?

In addition to the FDA and the manufacturer reporting problems about the medication, the consumer(patient) may also report problems with medications directly to the FDA through a monitoring system called MEDWATCH. Consumers can submit concerns to the FDA through this online reporting system.

How do I submit MedWatch?

Reporters may mail or fax paper forms to the Agency (a fillable PDF version of the form is available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf) or electronically submit a report via the MedWatch Online Voluntary Reporting Form (https://www.accessdata.fda.gov/scripts/medwatch/).

How do I submit a MedWatch report?

Submit the MedWatch 3500A within 7 days with 15-Day checkbox unchecked but still indicating initial (essentially, submitting written report “early” as initial report) Submit the MedWatch 3500A within 7 days with 7-Day checkbox checked. E2B submissions within 7-day with follow-up on or before day 15.

How do I submit a MedWatch form?

An online version of Form FDA 3500 [voluntary version] is available at www.fda.gov/medwatch/report.htm to allow health professionals and consumers to complete the form and transmit it electronically to the agency.

What is the MedWatch Form FDA 3500a used for?

The MedWatch Form FDA 3500A is used for the submission of adverse experience reports and reports of product problems required under the Food, Drug, and Cosmetic Act (FDCA) or by FDA regulations by entities such as user facilities, distributors, importers, applicants, and manufacturers.

How to report an adverse event to MedWatch?

Voluntary Reporting For use by Health Professionals, Consumers, and Patients 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 do you need to know about MedWatch?

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:

Which is the voluntary reporting form for the FDA?

FDA has a voluntary reporting form, Form FDA 3500B, that is customized to make the completion of the form by non-health professionals or consumers easier. You may continue to use this Form FDA 3500, but can find a link to the new consumer form on the MedWatch homepage: www.fda.gov/medwatch.