US FDA Complaints and 21 CFR 803 Medical Device Reporting

 21 CFR 820.3(b): Complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”

The below figure shows the complaints handling process,

Section 519 of Food, Drug and Cosmetic Act & 21 CFR 803 Medical device Reporting.

21 CFR 803(o) MDR reportable event (or reportable event):

 An event that reasonably suggests that devices:

(i) May have caused or contributed to a death or serious injury, or

(ii) Has malfunctioned and to cause or contribute to a death or serious injury if the malfunction were to recur.

21 CFR 803(k) Malfunction:

Failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device.

21 CFR 803(W)) Serious injury:

 an injury or illness that:

(1) Is life-threatening,

(2) Results in permanent impairment of a body function or permanent damage to a body structure, or

(3) Necessitates medical or surgical intervention

Mandatory Reporters:

1.Manufacturers shall report the following to FDA through electronic MDR using electronic submission gateway(ESG)

·       30 day reports of deaths, serious injuries and malfunctions

·       5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health

Voluntary Malfunction Summary Reporting Program: As of August 2018, Some of manufacturers may be eligible submit summary reports of medical device adverse events on a quarterly basis to the FDA.Some cases this summary reporting cannot be used(Example new type of reportable malfunction) .

You can determine the Voluntary malfunction summary reporting device eligibility in Product classification database.

2.Distributor shall report the following to FDA and/or manufacturer through electronic MDR using electronic submission gateway(ESG).They have to report within 30 calendar days of becoming aware of an event

·       Reports of deaths and serious injuries (Both FDA and Manufacturer)

·       Reports of malfunctions(Only Manufacturer)

2. Device User Facility (Examples-hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility) shall report the following to FDA and/or manufacturer through Form FDA 3500A .They have to report within 30 calendar days of becoming aware of an event

·       Device-related Death (Both FDA and Manufacturer)

·       Device-related Serious injury (Only Manufacturer)

User Facility shall submit the annual summary of death & serious injury reports to FDA (January 1 for the preceding year)

Voluntary reporters (health care professionals, patients, caregivers and consumers)

• Report using  MedWatch

Manufacturer and User Facility Device Experience Database - (MAUDE)

• Contains device specific mandatory and voluntary medical device reporting information

MDRs are used to identify:

·       CAPA

·       Device recall

·       Notice to public (Safety communications)

References

Medical Device Reporting (MDR): How to Report Medical Device Problems

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems#overview

MAUDE database

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Product classification database

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm