Tuesday, Sep 19, 2023

An Overview of Regulatory Compliance Risks and Costs

The Food and Drug Administration continues to scrutinize medical devices closely, so device manufacturers are taking extra care to avoid issues. However, compliance problems that are often easy to avoid cause problems for manufacturers.

 Medical devices that are non-compliant lead to a range of issues, including damage to the company’s reputation, financial losses, and legal problems. While this is clear enough, the details are not always easy to understand. Four categories of compliance challenges probably account for most of the issues that device manufacturers encounter.

CAPA Noncompliance

CAPA-related complaints account for more FDA 483 Observation Letters than any other issue. Company efforts at regulatory compliance can go wrong when someone misses an obscure detail. The FDA 483 Observation Letters that results are public records. Companies get in trouble because they do not follow CAPA procedures exactly, fail to comply with cGMP, or don’t have good quality management processes. 

Supply Chain Issues

A medical device manufacturer is responsible for ensuring the supply chain is compliant with relevant federal regulations. Components that violate federal standards are likely to be discovered. A couple of years ago, one in six medical device firms got 483 Letters because they did not have compliant purchasing controls. Minimize your supply chain risks by being familiar with all supply change partners and monitoring their processes.  

Inadequate Complaint Handling

Any medical device manufacturer without a solid process for handling complaints is bound to get in trouble with the FDA eventually. Mishandling of customer complaints is the second most common source of FDA 483 letters. Evaluate your process for receiving, recording, and addressing all customer complaints to reduce the odds of any failures.

Poor Quality Management

The FDA will be looking at your quality control as well as your complaint handling. Review your quality management, evaluate it according to an applicable standard, and make some adjustments where needed. Know what processes require validation and build validation steps into procurement, manufacturing, and testing.