Field Corrective and Safety Action (FSCA): A Comprehensive Compliance Guide

In the medical device industry, maintaining patient safety is the highest priority. When a device on the market poses a potential risk, a Field Corrective and Safety Action (FSCA) must be initiated to mitigate the risk of death or serious health deterioration.

What is a Field Corrective and Safety Action?

FIELD CORRECTIVE AND SAFETY ACTION, often called Field Safety Corrective Action (FSCA), involves manufacturer-led steps to address device risks post-market. Actions include device returns, modifications (e.g., software updates or labeling changes), or usage advice communicated via Field Safety Notices (FSN). The goal is preventing serious incidents like life-threatening injuries or permanent impairments.

Common Examples of FSCA:

• Device Returns: Recalling the product back to the manufacturer.
• Device Modification: Implementing design changes, such as software updates or "software locks" to make a device temporarily unavailable.
• Labeling Updates: Permanent or temporary changes to instructions for use (IFU) or device labeling.
• Professional Advice: Guidance provided by the manufacturer regarding the safe operation of the device

Key Roles and Responsibilities

To ensure regulatory compliance, specific roles within an organization must manage the incident reporting process:

Role	Responsibility
Marketing Officer	Reports the incident to the relevant national authority where the incident occurred.
Incharge Warehouse	Responsible for executing corrective actions in alignment with regulatory requirements.

Important Definitions in FSCA

Understanding these terms is critical for accurate reporting and compliance:

Adverse Event: Any death or serious deterioration in health, including life-threatening injuries or permanent body impairment.

Affected Product: The specific product subject to a complaint or investigation.

Complaint: Any communication (written or oral) alleging deficiencies in a device’s safety, quality, or performance after distribution.

Serious Public Health Threat: An event type resulting in imminent risk of death or serious injury requiring immediate remedial action.

The FSCA Reporting Process

When a medical device is suspected of being harmful, a formal Field Corrective and Safety Action Reporting Form must be completed. This ensures all data points are captured for regulatory review.

Mandatory Reporting Information:

1. Recipient Details: Contact information for the organization and person reporting the incident.
2. Product Specifics: Product name, catalogue number, lot/batch/serial numbers, and expiry dates.
3. FSCA Description: Detailed background information, justification for the action, and the implementation schedule.
4. Distribution List: A list of all countries where the affected product was distributed.

FIELD CORRECTIVE AND SAFETY ACTION REPORTING FORM

1. RECIPIENT DETAILS

Date of this report:
Type of report: ▯ Initial report ▯ Follow-up report ▯ Final report
FSCA reference number:
Name of recipient organization:
Name of contact person:	Email of contact person:
Street and No .:	City and postcode:
Country:	Telephone:

 

2. MANUFACTURER DETAILS

Name of manufacturer::
Name of manufacturer:	City and postcode:
Street and No .:	Telephone
Country:
Name of contact person:	Email of contact person:
Reference number assigned by the manufacturer:

3. PRODUCT DETAILS

Product name:

Product code (catalogue number):

Lot number/batch number/serial number:

Expiry date:

Associated devices/accessories (lot numbers/expiry dates):

Instructions for use version number:

Please attach a copy of the instructions for use.

4. FSCA description

Background information and reason for the FSCA:

Description and justification of action (corrective/preventive):

Date complaint reported to manufacturer (and/or distributor)::

Advice on actions to be taken by distributor and the user:

Field Safety Notice attached:

Time schedule for implementation of different actions:

List of countries this FSCA has been distributed to:

5. COMMENTS

6. SIGNATURE

Name:

Signature:

Date: