Medical Device Companies: Understanding Compliance Issues & Penalties

If you work in the medical device industry, then you already know there is a lot more involved than just the concept, design, and manufacturing of medical equipment. There are multiple steps to get your device on the market from innovating the idea, to patenting research and intellectual property, to getting registered and in compliance with the FDA (Federal Drug Administration). The FDA pays careful attention to every step in the development, trials, and creation of your medical device, as well as after the production, too. Click To Tweet

Key Medical Device Compliance Issues

There are numerous steps in establishing and getting a medical device on the market, and it is important to understand compliance issues and penalties to fully grasp what needs to happen with the processes and requirements the FDA places on medical device companies. Here are some of the top key medical device compliance issues and their consequences to help you better comprehend what is involved.

Corrective & Preventive Action (CAPA)

Non-compliance with CAPA regulations is one of the most commonly cited areas for medical device companies, according to the FDA, and most often “procedures for preventative and corrective action have not been (adequately) established.” Make sure to establish your CAPA procedure as part of your overall quality management system so you can properly document everything.

Medical Device Reporting

Another issue that medical device companies run into is not having proper medical device reporting (MDR) procedures, as laid out under FDA Code 21 CFR 908.17. Most common compliance issues with medical device reporting are:

  • There is no written procedure or plans to implement a written procedure which satisfies FDA requirements.
  • Important terms have been omitted, such as “cause or contributed”, “become aware”, “malfunction”, “reasonably suggests”, or MDR reportable event”.
  • Key descriptions have been omitted. For example, when a certain procedure is required to kick in.

Handling Complaints

Medical device companies are required to follow procedures for handling complaints. If you are not properly handling complaints, you may experience recalls or even product seizure by the FDA. Be sure to clearly document complaint procedures used by your company, implement changes and close out any complaints in a timely manner, and keep records to track and monitor complaints.

Non-Conforming Materials

Medical device companies use of non-conforming materials is not rare, in fact, this matter was fourth on the list of non-conformance issues. According to the FDA, each manufacturer must establish and maintain procedures addressing the identification, documentation, evaluation, segregation, and disposition of all non-conforming products.

Medical Device Non-Compliance Consequences

So what happens if your medical device happens to be non-compliant? Here are a few consequences that might occur.

FDA Audit

Always know that the FDA can come and audit your device at any time. If you manufacture Class II or Class III products, it has been said to expect an audit about every two years.

Form 483

If the FDA inspector happens to find anything non-compliant, you will be issued what’s called a from 483. The form outlines any questionable conditions and gives businesses 15 days to respond and take action.

Reputable Damage

Being non-compliant can also damage your business’s reputation. The FDA’s warning letters are available through public domain. People are able to see the reason for the warning, as well as the work you’ve done to correct it.

Medical Device Companies: Be Prepared

When you are involved in medical technologies, you have to be properly prepared. Make sure to learn what the requirements and guidelines are and go through the proper steps like registration, medical device testing, and other compliance requirements.

To learn more about protecting your company from compliance issues and penalties, Contact Us.

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