fda-510k-programIf you are a medical device company in the U.S., did you know FDA is required to inspect all class II and class III medical device companies every two years?

When was the last time you had a FDA inspection?

If it's been at least two years, are you ready for a FDA inspection?

How are your Design Controls and Design History Files?

Before you can answer that question, it might be helpful to get a better idea of just exactly what to expect during a FDA inspection.

Most everything about the FDA inspection process can be found on FDA's website.

Let me walk you through this process, having been through several FDA inspections.

greenlight.guru is the only quality management software platform designed exclusively for medical device companies. You can view our full platform and services here.

  1. FDA contacts you to schedule an inspection. While FDA can show up unannounced, it is far more likely that FDA will contact you via phone. But if your product has issues in the field, FDA may be more likely to show up one day.

  2. Work with FDA to schedule dates of inspection. Usually, FDA is willing to work with you on picking dates that will work for your company (within reason). Expect the FDA inspection to last every bit of 5 days.

  3. On the start date, FDA inspector will show up at your facility and present a Form 482 Notice of Inspection. The FDA inspector will also present his credentials. Yes, he has a badge and is a federal law enforcement official.

  4. The FDA inspector will likely describe the purpose for his visit but don't expect an official FDA inspection agenda. He will probably want to do a walk-through of your facility as one of the first orders of business.

  5. After the walk-through, the FDA inspector will dive right in. Expect him to start with Medical Device Reporting and complaint handling. (Medical Device Reporting (MDR) is addressed in 21 CFR part 803 and Complaints in 21 CFR part 820.198.)

  6. Generally, FDA is likely to follow Quality System Inspection Techniques (QSIT) during your FDA inspection. You should review FDA QSIT guidance document prior to the inspection. The inspection will take several days. Each day the FDA inspector is likely to give you a verbal summary of the day. You should expect the inspection to have some interruptions. It is common for the FDA inspector to reschedule parts of the inspection.

  7. As the FDA inspector wraps up the inspection, he will share with you a summary of his observations. In the event the inspector found issues, he will discuss and provide a draft of FDA Form 483 Inspectional Observations. The inspector will ask if you agree to correct the issues and record your responses. You are expected to provide a response to FDA 483 observations within 15 days.

  8. If you receive any 483 observations and/or a warning letter, you will then engage FDA on your corrective action plans and continue correspondence with the agency until you receive notification from FDA.

  9. Sometime after the inspection, you will receive an official FDA Establishment Inspection Report. Depending on your 483 responses and severity of the issues observed will determine the next steps. If you have significant deficiencies, FDA may decide to issue a warning letter.

  10. Once you close out any issues, it is very likely that FDA will show up again to re-inspect your facility. This re-inspection is more likely to be unannounced.


 

Guide to Design Controls for the Medical Device Industry


 

Jon Speer, Co-founder greenlight.guru

Written By Jon Speer


Jon is the founder and VP QA/RA at greenlight.guru (quality management software exclusively for medical devices) & a medical device guru with over 18+ years industry experience. Jon knows bringing a device to market is hard, so he built greenlight.guru to make it easier. Click here to get our actionable medical device insiders content delivered right to your inbox 1x per week.


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