Six Things You Should Know About FDA Medical Device Quality System Audits

Business Blog

Medical facilities relying on medical device use need to understand what FDA audits are and what their consequences can be. The following are six things you should know about FDA medical device quality system auditing

One common type of FDA audit is the pre-approval inspection.

The FDA will require a pre-approval inspection if a medical device company wishes to put a newly developed product on the market.

The pre-approval inspection will simply make sure that all the information on the application to the FDA is accurate. During the pre-approval inspection, the FDA will also verify that the company that is applying is capable of successfully manufacturing the product in question. 

Other common types of inspection are routine inspections and compliance follow-up inspections.

Medical device manufacturers generally have to undergo routine inspections every few years. The frequency with which inspections are necessary depends on the class of the medical device that the company is manufacturing.

Medical device manufacturers may also have to undergo a follow-up inspection if issues came up in a previous routine inspection. 

The FDA may require a "For Cause" inspection if a problem gets reported to them.

The FDA will conduct a "For Cause" inspection if there has been a problem with a medical device that was reported to the FDA. 

The FDA can sometimes conduct unannounced audits.

It's important for medical device manufacturers to be aware of the fact that the FDA is authorized to conduct audits unannounced. This means that manufacturers need to keep themselves prepared for an audit at any given moment. 

Conducting routine audits internally can help keep you prepared for FDA audits.

One of the best ways to remain prepared for an unannounced audit by the FDA is to conduct routine internal audits at a medical device manufacturing company. 

Companies should develop a schedule for routine audits. They can also have audits conducted by third-party consultants to ensure that they are meeting requirements they would need to meet to pass an FDA audit. 

There are numerous possible consequences of failing an FDA medical device quality system audit.

If there are issues that come up in an inspection, the FDA will provide the medical device manufacturer with what's known as FDA Form-483. This form will explain any violations that were detected during the audit. 

Your company will be expected to respond in writing after receiving FDA Form-483. The response should detail how any issues will be addressed. The FDA will schedule a compliance follow-up inspection at some date in the future to ensure that the manufacturer has successfully addressed the issues.  


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