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Meet FDA RequirementsMeet FDA Requirements for Medical Device Company Compliance

Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations ensure that you deliver safe and effective products. Knowledge and experience is required to do this effectively and to avoid costly mistakes.

At this point, it’s important to realize that although we talk about the FDA as a regulatory body, it is, in fact, a law enforcement agency with the powers associated with such authorities. The FDA can cite, fine and prosecute for violations of laws, such as 21 CFR Part 820 or 21 CFR Part 11. The laws the FDA enforces are administrative laws that are part of a national regulatory scheme, like police law and international trade.

Medical device companies not compliant with 21 CFR Part 820, and other applicable regulations, make themselves vulnerable to FDA enforcement practices. The tricky part is that the FDA doesn’t tell you how to operate as a compliant company. You have the flexibility to implement the necessary processes to satisfy the applicable regulations and support them with your own compliance practices. However, you’re expected to fully understand the intent of the regulations and meet those expectations—regardless of your size and resources.

While FDA enforcement actions rarely result in jail time for executives, they can force expensive corrections and cause significant damage to your reputation. Truly, it’s best to comply to FDA requirements willingly and faithfully.

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