Regulatory Open Forum

Has anyone teased apart the confounding overlap between reporting requirements in 21 CFR 7, 803, and 806? Specifically, how does MDR reporting (803) differ in scope and timeline from reports/notifications to FDA in the event of a recall (7), or in the event of a reportable correction or removal (806). 

Any help or words of wisdom would be welcomed. 

Thank you,

The easiest way to start assumes there is no connection between Part 803 and Part 806 and to ignore Part 7.

Both Part 803 and Parts 806 cover reports to FDA so it is convenient to state certain characteristics: What triggers the report, When is it due, What is the content, Who is it transmitted, and What records when it is not reportable.

Part 803 covers reportable events related to death or serious injury.

Trigger: You learn that device has a) caused or contributed to a death or serious injury, b) the device malfunctioned and if it were to happen again, could cause or contribute to a death or serious injury.

Due: In most case, within 30 days of becoming aware, but there are special cases for 5 day reports

Content: The regulation has prescribed data elements for medical devices

Transmission: Must use an eMDR system that gets the information to the right place in FDA’s Electronic System Gateway

Not reportable: When investigation reveals it is not reportable, document the reason why in the MDR Event File.

Every complaint (820.198) must be evaluated for reportablility. Every MDR must have an associated complaint, but the converse is not true.

Part 806 covers changes you make to a device you have already shipped.

Trigger: You initiate the change to a shipped device

Due: 10 days after initiation

Content: The regulation lists the prescribed data elements

Transmission: Send it to the district recall coordinator by the method she prefers

Not reportable: You must keep records with prescribed data elements

You should evaluate every design change for the reason you make the change because some decision changes must result in changes to shipped devices, which could be reportable.

If you report under Part 806, FDA will use Part 7 to decide if the report requires a recall and will classify it. Remember that the device manufacturer does not make the recall decision or define the class. You only decide whether the issue is reportable under Part 806.

Dan, 

Thank you for the helpful reply!

From what you say, I assume firm-initiated recalls are quite rare and only occur when the firm is certain its product is subject to seizure and they want to get the recall completed asap. It seems advantageous in any other case to simply report under 803 or 806, and let FDA decide to trigger a recall as per part 7. Would you agree with that comment?

Regards,

I would not agree with this.

When you submit a Part 806, assume you are initiating a voluntary recall. The recent guidance document tries to clarify when these reports are due. A common example is an update to the Instructions for Use that helps reduce a risk to health. If you were to do this, then you would notify FDA under Part 806 and they would, probably, initiate the recall process under Part 7.

None of this relates to seizure, which is a legal act usually involving a court order, US Marshalls, etc.