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Field Safety Corrective Action (FSCA) – US FDA

What is Medical Device Reporting?

Medical Device Reporting (MDR) is one of the FDA’s post-market surveillance techniques for monitoring device performance, detecting potential device-related safety concerns, and contributing to device benefit-risk assessments.

  • There are mainly two groups of reporters of which the mandatory group includes the manufacturer, importers and device user facilities, and the voluntary group includes healthcare professionals, caregivers, patients, consumers
  • Once submitted, the FDA reviews the MDR and validates the totality of the given information
  • The MDR submission by itself cannot act as evidence that the medical device reporting is responsible for a particular adverse event unless the reporter believes that the adverse event has or may have occurred due to the device or the medical device reporting has a role in the mentioned event

What Event Qualifies to be Reported?

  • A medical device reporting placed in the market contributes to a death or a serious injury
  • A medical device reporting has malfunctioned and is likely to cause death or a serious injury if the malfunction were to recur

Who can Report an Adverse Event to FDA?

It is considered mandatory for the manufacturers, importers, and device user facilities) of reporters to report any adverse event through form FDA 3500A.

The summary of Requirements for Mandatory Reporting:

ReporterDescriptionFDA Form(s)Report toWhen to Report
Manufacturer30-day reports of deaths, serious injuries, and malfunctionsFDA 3500AFDAWithin 30 calendar days of becoming aware of an event
 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 healthFDA 3500AFDAWithin 5 workdays of becoming aware of an event
ImportersReports of deaths and serious injuriesFDA 3500AFDA and the manufacturerWithin 30 calendar days of becoming aware of an event
 Reports of malfunctionsFDA 3500AManufacturerWithin 30 calendar days of becoming aware of an event
User FacilityDevice-related DeathFDA 3500AFDA & ManufacturerWithin 10 workdays of becoming aware
 Device-related Serious injuryFDA 3500AManufacturer. FDA only if manufacturer unknownWithin 10 workdays of becoming aware
 Annual summary of death & serious injury reportsFDA 3419FDAJanuary 1 for the preceding year

(source-FDA Website)

The voluntary reporting can be done through MedWatch Online reporting Form or by requesting for assistance by calling 1-800-332-1088:

  • Healthcare professionals are advised to report through form FDA 3500
  • Patients/Consumers are advised to report through form FDA 3500B

In case of Emergencies, reporting can be done by contacting the FDA Office of Crisis Management, Emergency Operations Centre.

Who is Responsible to carry out Corrective Action for the Reported Event?

For any reportable or reported adverse events, the manufacturer is obliged to carry out a corrective action such that the implemented corrective action and preventive action aims to eliminate any medical device reporting malfunctions related to patient safety.

The manufacturers, importers and the user facilities are primarily responsible for carrying out a corrective action whose goal is to gather data, evaluate it, detect and investigate product and quality issues, and then take suitable and effective corrective action to keep them from happening again.

Top 5 Medical Device Safety Action Plan Objectives

FDA carries out inspections to ensure that the corrective actions undertaken by the manufacturer are well adequate to eliminate any recurring adverse events.

The Key objectives of such inspections are:

  • To create a medical device patient safety net in the United States of America
  • To put forward a system to check on the latest regulatory options to implement postmarket mitigations
  • To guide innovations to make a safer medical device
  • Bring Improvements in medical device cybersecurity
  • Integrate the premarket and post-market offices and operations of the Centre for Devices and Radiological Health (CDRH) to promote the implementation of a TPLC (Total product life cycle) approach to device safety

Corrective and Preventive Action (CAPA) Procedure

Every manufacturer is mandated to establish and maintain a CAPA process as per the FDA’s Quality System Regulation (QSR) 21 CFR 820.100.

The process must well contain the requirements on input data sources, decision criteria of non-conformance, investigational procedure, root cause analysis, actions to address the non-conformance, effectiveness verification procedure, implement actions to eliminate recurring problems taking into consideration about the in-house product design changes as well as the impact to existing products in the market.

The FDA requires all these activities to be documented and recorded.

  • Manufacturers are required to create a report as per 806.10 of any corrective actions implemented on the device and submit it to the FDA
  • Manufacturers and Importers must also keep records of the corrective actions that are not required to be reported to the FDA. Voluntary submission of such a report can be done based on 21 CFR 7

FDA’s Inspection Operation

On various grounds, the FDA performs inspections such as scheduled investigations, surveys, or a response to a reported problem. FDA’s Office of Regulatory Affairs (ORA) leads all such inspectional operations.

There are FDA Forms involved in these inspections,

  • Form 482 “Notice of Inspection” presented by the FDA immediately prior to inspection
  • Form 483 is issued to the firm’s management at the conclusion of the inspection if the investigator determines observations that violate the FD&C act rules

Objectives of Inspection after implementation of a Corrective Action

  • Check if the corrective actions implemented have been well defined and documented
  • Verify if the right sources of product and quality issues have been found
  • Check if there are any unfavourable trends in the product and quality information
  • Verification of the received data based on completeness, accuracy and time of reception
  • Check if appropriate statistical methods are applied to detect and identify the extent of recurring quality problems
  • Verify if a failure investigation is carried out and check if there has been a genuine attempt to find the root cause (wherever possible)
  • Check if there is control for the prevention of distribution of non-conforming products
  • Verify if appropriate actions have been taken for significant product and quality problems identified from data sources
  • The effectiveness of the corrective action is validified and verified before implementation by ensuring that the corrective actions do not lead to any adverse effects on the finished device
  • Check if corrective actions for product and quality problems were implemented and documented
  • Verify if all non-conforming product and quality problems and corrective actions have been properly disseminated, including dissemination for management review

FAQ

What is the Voluntary Malfunction Summary Reporting Program?

It permits manufacturers to report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis.

The VMSR program lets the manufacturers submit separate summary reports for each unique combination of the device model, brand name, device model, and problem code(s).

Every summary report is made available to the public in the MAUDE. It is mandatory to submit individual reports of death or serious injury events continue to be required, under sections 803.50 and 803.52, or 803.53, as applicable.

How to report Medical Devices licenced as biological products?

CBER (Centre for Biologics Evaluation and Research) is designated the lead centre in the FDA for regulating in vitro diagnostic (IVD) medical devices intended for screening or confirmatory clinical laboratory testing associated with blood banking practices and other process testing procedures.

IVD devices licensed as biological products are also subject to the applicable regulations under 21 CFR Part 803 – Medical Device Reporting.

Where to search for the medical device Reports?

The Manufacturer and User Facility Device Experience database contains mandatory reports filed by manufacturers and importers from August 1996 to the present, all mandatory user facility reports from 1991 to the present, and voluntary reports filed after June 1993.

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

What are the data that are not required to be presented for routine review?

In accordance with Agency policy (CPG 7151.02), records regarding the results of internal quality audits, management reviews, third-party audits (including ISO audits), or supplier audits are not required to be presented.

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