How do I report a medical device to the FDA?

How do I report a medical device to the FDA?

Voluntary MedWatch Reporting for Patients, Health Professionals and Consumers (Form FDA 3500):

1. Complete the MedWatch Online Reporting Form.
2. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Where are the MDR policies kept?

FDA’s Manufacturer and User Facility Device Experience (MAUDE) database contains all mandatory and voluntary MDRs filed since 1993. Companies have near-instant access to any adverse event report that’s been made about one of their own devices, or those of a competitor.

What is the FDA Maude database?

The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

When should a medical device report be submitted?

You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility.

How do I report to the FDA?

You can report a problem to the FDA online, via phone, or via mail. For emergencies: Call 9-1-1 immediately. In limited emergency situations (which are urgent but not life-threatening), you or your health care professional can report problems to the FDA’s emergency line at 1-866-300-4374 or 301-796-8240.

How do I report non compliance to the FDA?

If you have questions about submitting an allegation, you may contact the Allegations of Regulatory Misconduct Staff by phone at (240)402-7675 or by email at [email protected].

What is an FDA reportable event?

(o) MDR reportable event (or reportable event) means: (1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or.

What information from medical device reports MDR can FDA disclose to the public?

(a) We may disclose to the public any report, including any FDA record of a telephone report, submitted under this part. Our disclosures are governed by part 20 of this chapter. (3) Any names and other identifying information of a third party that voluntarily submitted an adverse event report.

How do I find a FDA complaint?

Report a problem with FDA-regulated products

1. Call 1-888-INFO-FDA (1-888-463-6332).
2. Call the FDA Consumer Complaint Coordinator for your state or region.

What is MDR report key?

The Master Event file includes two database key fields: MDR REPORT KEY which identifies unique reports and is important for linking most of the MAUDE files together and EVENT KEY which is an internally-generated field used to identify unique events.

How do I make a complaint to the FDA?