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Compliance In Focus
Posted by Brandy Chittester on Tue, Jun 11, 2013

Do Device Post-Market Studies Follow 812?

It just depends!

Do Device Post-Market Studies Follow 812?Recently during a monitoring visit for a post-market study, the monitor noted that the site inadvertently destroyed patient records.  Typically, the monitor would re-educate the site on 21 CFR 812.140(d) that an investigator shall maintain patient records throughout an investigation and for a period of two years after the latter of the following dates: the date the investigation is terminated or the date that the records are no longer required for purposes of supporting a premarket approval.

But, in this case (a post-market study), does the site have to comply with 812? Or, do they only have to retain the records for two years since the records aren’t needed to support a premarket approval?

As usual we ask, “What do the regulations say?”

Here is what was known:

  • It was a post-market study
  • The study was looking at an indication not yet approved by the FDA

In reviewing the Frequently Asked Questions about Medical Devices on the FDA website, we found the following:

  • Studies of an already cleared medical device in which the device is used or investigated in accordance with the indications in the cleared labeling are exempt from Part 812.
  • Studies of a cleared device for a new use must comply with the human subject protection (informed consent and additional safeguards for children in research), IRB, and IDE regulations.

Just what the monitor was looking for…and why it just depends!

In this case, the site did need to follow 812 since the study was a device for a new use.  In the explanation to the site for why they should not have destroyed any patient records, the monitor was able to site 21 CFR 812.140(d).

Have you had similar experiences while monitoring?  Please share your stories with us.

Photo Credit: CTSIatUCSF

Auditing vs Monitoring blog CTA

Topics: Post-Market Studies, 21 CFR 812.140(d), Pre-Market Study, Clinical Monitoring

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