What will be reported in MedWatch 3500?

What will be reported in MedWatch 3500?

The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

What is an FDA 3500 form?

Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.

What should I report to MedWatch?

What to Report to FDA MedWatch: Use MedWatch to report adverse events (observed or suspected) for human medical products, including serious drug side effects, medication errors/product use errors, product quality problems, and therapeutic failures.

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.

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 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 primary purpose of MedWatch?

What do you need to know about FDA form 3500?

Information for Consumers, Patients and Caregivers: 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.

Can a voluntary report be submitted to MedWatch?

They should generally not be submitted to FDA MedWatch as voluntary reports. 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.

What are the instructions for form FTB 3500?

Specific Instructions 1 General Questions. All organizations complete form FTB 3500, Side 1 through Side 5. 2 Part III Financial Data. Include receipts and expenses from all sources. 3 Specific Section Questions. 4 Additional Questions. 5 Attachments.