Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

PMAs are subject to "periodic reporting" via 814.82(a)(7), usually defined as annually in the PMA Approval letter, due annually from the date of approval.  However, the annual report must include information (eg, number devices distributed) that cannot be generated instantaneously. 

There must be an acceptable window after the anniversary date that FDA expects such reports (30d? 60d?) to permit the collection and analysis of the reporting period data.  However, I cannot find any information/guidance on how long after the anniversary date it is acceptable to submit the PMA annual report.

Any guidance, experience, "accepted practice" would be appreciated.

Hello Anon,

Indeed there is not information when what the "end date" or a window for making submissions.  Though without seeing the actual PMA Approval Letter might be some conjecture, however, can explain what I have done in the past.  You are correct that on the anniversary some of the data available such as sales volume, customer complaints, and adverse events reports may not be completely through the internal system.  You can create a "complete" date which is say 30 days before the annual date where you compile everything up to that point.  This happens just on the first annual report, but then subsequent annual reports thereafter can be in a 12 month period.  What is important is the organisation does not take weeks and weeks (or months) to compile the data.  While you can not do this instantaneously - it also has to be done in a timely manner.  The important things I found is clearly define the dates from when the data is gathered, reviewed, analysed, and reported.  After the first annual report as said it is easier to create a 12 month rolling period - just make sure you stay on top of this, because in subsequent years if delays occur, it pushes it out further.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 03-Oct-2022 14:39
From: Anonymous Member
Subject: PMA Annual Report timing

This message was posted by a user wishing to remain anonymous

PMAs are subject to "periodic reporting" via 814.82(a)(7), usually defined as annually in the PMA Approval letter, due annually from the date of approval.  However, the annual report must include information (eg, number devices distributed) that cannot be generated instantaneously.

There must be an acceptable window after the anniversary date that FDA expects such reports (30d? 60d?) to permit the collection and analysis of the reporting period data.  However, I cannot find any information/guidance on how long after the anniversary date it is acceptable to submit the PMA annual report.

Any guidance, experience, "accepted practice" would be appreciated.

As Richard says, I recommend choosing a date about a month or so before the anniversary date and compiling/analyzing all data as of that date.  In your report and cover letter, indicate that all information is "as of" that date.  By all means, submit on time, by the anniversary date.

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Douglas Ferguson
VP, Clinical and Regulatory
Concord MA
United States
------------------------------

Original Message:
Sent: 03-Oct-2022 14:39
From: Anonymous Member
Subject: PMA Annual Report timing

This message was posted by a user wishing to remain anonymous

PMAs are subject to "periodic reporting" via 814.82(a)(7), usually defined as annually in the PMA Approval letter, due annually from the date of approval.  However, the annual report must include information (eg, number devices distributed) that cannot be generated instantaneously.

There must be an acceptable window after the anniversary date that FDA expects such reports (30d? 60d?) to permit the collection and analysis of the reporting period data.  However, I cannot find any information/guidance on how long after the anniversary date it is acceptable to submit the PMA annual report.

Any guidance, experience, "accepted practice" would be appreciated.

As others have mentioned, we have submitted annual reports 30 days prior to the anniversary date and have clearly stated the reporting time period so far and no concerns raised by the Agency.

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Sri Lekha Eedulakanti
Regulatory Affairs Manager
Richmond BC
Canada
------------------------------

Original Message:
Sent: 03-Oct-2022 14:39
From: Anonymous Member
Subject: PMA Annual Report timing

This message was posted by a user wishing to remain anonymous

PMAs are subject to "periodic reporting" via 814.82(a)(7), usually defined as annually in the PMA Approval letter, due annually from the date of approval.  However, the annual report must include information (eg, number devices distributed) that cannot be generated instantaneously.

There must be an acceptable window after the anniversary date that FDA expects such reports (30d? 60d?) to permit the collection and analysis of the reporting period data.  However, I cannot find any information/guidance on how long after the anniversary date it is acceptable to submit the PMA annual report.

Any guidance, experience, "accepted practice" would be appreciated.

This message was posted by a user wishing to remain anonymous

We have always submitted 30 days prior to anniversary date and have clearly indicated the time period of the data reported, no concerns received the Agency with this practice till date.
Original Message:
Sent: 03-Oct-2022 14:39
From: Anonymous Member
Subject: PMA Annual Report timing

This message was posted by a user wishing to remain anonymous

PMAs are subject to "periodic reporting" via 814.82(a)(7), usually defined as annually in the PMA Approval letter, due annually from the date of approval.  However, the annual report must include information (eg, number devices distributed) that cannot be generated instantaneously.

There must be an acceptable window after the anniversary date that FDA expects such reports (30d? 60d?) to permit the collection and analysis of the reporting period data.  However, I cannot find any information/guidance on how long after the anniversary date it is acceptable to submit the PMA annual report.

Any guidance, experience, "accepted practice" would be appreciated.