Get Fsca Report Form

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

The Corrective Action Record is used to record the problem, root cause analysis, and corrective actions taken for the problem. The document is optimized for small and medium-sized organizations – we believe that overly complex and lengthy documents are just overkill for you.

A Field Safety Corrective Action is an action taken by a manufacturer to report any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer to the National Competent Authority.

1. Before filling this form, the reporter collects and collates the prescribed information in the form. 2. This form will serve as the reporting tool in lieu with the Medical Devices Rules, 2017.

Field safety corrective action (FSCA) may be requested by the Medical Device Authority for specific cases such as complaints and mandatory problem reporting (MPR). Field safety notice should be presented to the user and the Medical Device Authority before or during corrective action is taken by the establishments.

on Feb 18, 2022. A corrective action plan (CAP) is part of safety management. It is a step-by-step set of actions designed to identify issues and gaps in the system and identify the root cause to prevent recurrence. When an internal or external audit is completed, they can reveal safety concerns.