21 CFR Part 803 — Medical Device Reporting

MDR requirements, reportable event criteria, and Veridian Corp reporting procedures

CFR Part: 21 CFR Part 803

Title: Medical Device Reporting

Form: FDA 3500A

Veridian SOP: SOP-MDR-001

Reportable Event Criteria (§803.3)

Event Type	CFR Reference	Definition	Reporting Timeline
Death	§803.50(a)(1)	Device may have caused or contributed to a patient death	30 calendar days
Serious Injury	§803.50(a)(2)	Device may have caused or contributed to serious injury	30 calendar days
Malfunction	§803.50(a)(3)	Device malfunction that would likely cause death or serious injury if recurrence	30 calendar days
5-Day Report	§803.53	Remedial action initiated to prevent unreasonable risk of death or serious injury	5 working days

All employees must report potential device-related adverse events to Regulatory Affairs within 24 hours of becoming aware per SOP-MDR-001.

The Regulatory Affairs team must complete reportability determination within 5 business days using the MDR Decision Tree (Form MDR-DT-001).

FDA Form 3500A must be submitted electronically via eMDR within 30 calendar days for all reportable events per 21 CFR 803.50.

Supplemental or follow-up reports must be submitted within 30 calendar days when new information becomes available per 21 CFR 803.56.

MDR records must be retained for a minimum of 2 years from the date of the report per 21 CFR 803.30.

Device	510(k)	Serious Injury	Malfunction	5-Day Reports
Veridian Pulse Monitor	K240847	2	8	0
Veridian Glucose Patch	K231156	1	14	0
Veridian Insulin Delivery	K220893	3	11	1
Veridian Thermometer	Exempt	0	2	0