FDA Remote Regulatory Assessment (RRA) Overview

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
  • It's ok to decline this FDA offer of this RRA but it could cause an earlier onsite
  • Passing the RRA pushes your audit scheduled to some # of years later
  • No 483 are possible but if major violations are found could trigger an immediate onsite audit
  • Usually, a 1-hour meeting starts the day with discussion and requests
  • emailing requests. FDA can accept up to 100MB per email so adjust your email server accordingly
  • On-Call from 9:30 to 3:30 for questions from FDA
  • Top-Down - SOP to records
  • Topics so far - CAPA, NCR, Complaints, Investigation, Corrections and MDR, Design Controls, A review of your latest design change, Training Specifically for Management Rep and meeting attendees and production key persons responsible for QC checks, Supplier approval and monitoring.
  • A verbal closing meeting with any findings
  • Have to FOIA the memo from FDA written to document in your QMS
 
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Watchcat

Trusted Information Resource
#2
Nice summary, thanks!

Do RRAs tend to last about as long as onsites? Or are they a good bit longer or shorter?
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#3
Shorter. They are covering topics lightly and as usual always CAPA + 1 subsystem. They are auditing 3-4 companies at a time.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#5
Also be careful of submitting your FOIA too early. There is a FOIA log on the FDA website with more examples


2021-2582 (April 2021)
Seventh Generation​
Please provide me with the report from the Seventh Generation Remote Regulatory Assessment
No Record(s)​




2021-4167 (June 2021)
Seventh Generation
Summary Report for Seventh Generation Medical Device Remote Regulatory Assessment conducted 04/13/2021 - 04/15/2021
Closed


The first example they submitted the FOIA too early and they closed the request with no records. They had to resubmit.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#6
Also be careful of submitting your FOIA too early. There is a FOIA log on the FDA website with more examples


2021-2582 (April 2021)
Seventh Generation​
Please provide me with the report from the Seventh Generation Remote Regulatory Assessment
No Record(s)​




2021-4167 (June 2021)
Seventh Generation
Summary Report for Seventh Generation Medical Device Remote Regulatory Assessment conducted 04/13/2021 - 04/15/2021
Closed


The first example they submitted the FOIA too early and they closed the request with no records. They had to resubmit.

Here are some notable ones

POLITICO I request all records of communications between FDA and the White House regarding cases of myocarditis among Covid-19 vaccine recipients. Please include all meeting logs and associated agendas on this topic.

The New Yorker correspondence to or from the Director, his Chief of Staff, the Principal Deputy Director, the Chief Medical
Officer, and the Deputy Director for Infectious Diseases that discusses the response (including, but not limited to, plans, operations, and communications) of the White House (including, but not limited to, the President, Vice-President, Chief of Staff, Senior Advisors, and National Security Council) to the novel coronavirus outbreak.

POLITICO I request all records of communications between FDA and the CDC regarding cases of Guillain-Barre syndrome associated with the Johnson & Johnson Covid-19 vaccine.

POLITICO I request all records of communications between FDA and the CDC regarding cases of myocarditis and pericarditis among recipients of the Pfizer-BioNTech and Moderna Covid-19 vaccines.

POLITICO I request all records of communications between FDA and the CDC regarding the Johnson & Johnson Covid-19 vaccine pause in April 2021. Please include all meeting logs and associated agendas on this topic.

POLITICO I request all records of communications between FDA and the White House regarding cases of Guillain-Barre syndrome associated with the Johnson & Johnson Covid-19 vaccine.

THE ASSOCIATED PRESS 1. For all accounts managed by the Food and Drug Administration, all of the metadata information contained in the email headers relating to emails: A: Sent To, From, CC, or BCC from the following addresses or accounts: [email protected]; [email protected]: [email protected]; and [email protected]. B: Sent To, From, CC, or BCC to any address ending in the domain: @biogen.com C: Containing any of the following terms in the subject line: “Call” “Meeting” “761178” “Talk” “Approval” “Accelerated” and “Good.”


THE DALLAS MORNING NEWS Under the Federal Freedom of Information Act, please provide any and all correspondence related to tests of Oleandrin on patients by Houston physician Dr. Kimberly Dunn, FROM Dr. Stephen Hahn and/or his staff TO Dr. Ben Carson and/or his staff. (Please note that under my earlier request 2021-2973 (still pending), I had asked for correspondence going the other direction, i.e. from Carson to Hahn.) Thank you.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
The letter FDA responds with for FOIA look like this:

Dear Requester: The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding: Summary Report for COMPANY XXXX Medical Device Remote Regulatory Assessment conducted 08/03/2021 – 08/06/2021 by Talmane Fisher, FDA

We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see FOIA Fees.

Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved.

Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process. If you have any questions about your request, please call Rochelle A. Coleman, Information Technician, at (301) 796- 8982 or write to us at: Food and Drug Administration Division of Freedom of Information 5630 Fishers Lane, Room 1035 Rockville, MD 20857 If you call or write, use the FOIA control number provided above which will help us to answer your questions more quickly.

You also have the right to seek dispute resolution services from: Office of Government Information Services and/or FDA FOIA Public Liaison National Archives and Administration Office of the Executive Secretariat 8601 Adelphi Road – OGIS US Food Administration College Park, MD 20740-6001 5630 Fishers Lane, Room 1050 Telephone:202-741-5770 Email: [email protected] Toll-Free: 1-877-684-6448 Email:[email protected]
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#8
Also this:

8/6/2021 conclude RRA with FDA

Ask about timing to FOIA the report memo for our records; two weeks should be fine, per FDA auditor.

8/23/2021 request FOIA to FDA for memo

FDA RESPONSE:
The requested records have not been completed please cancel your request and wait 60 days to reapply for the items.

Please respond to this email with your cancellation.

Best regards,

I then respond to this email requesting to cancel my FOIA request.

I receive an out-of-office message for two weeks and a new person's email to work with.

I forward my cancellation request to this new person and they too have an out-of-office message.

I can't make this up.

Why must I cancel my FOIA request? Why cant they wait until the records are available?
 

Watchcat

Trusted Information Resource
#9
Why cant they wait until the records are available?
Just a guess, but...

Perhaps response time is one of their performance metrics. This allows them to turn off their meter and reduce "average" turnaround time. In FOIA's defense, if it works like it does in a lot of organizations, this metric may have rolled downhill onto FOIA, which may have little to no control over how soon "other HHS components or other executive branch agencies " will complete the requested documents and make them available to FOIA. This provides cover for those who are way behind in their paperwork.

Back during my grassroots activist days, the new head of our local 911 center ask me to help persuade our city council to fund much-needed improvements, including certification to a recognized national standard. Among other things, he discovered that the previous director had set the system to automatically disconnect calls that hadn't been answered after a certain number of minutes, to reduce the average response time. If you've ever spent a long time waiting for customer service or tech support to pick up, only to get disconnected, they've probably done the same thing, for the same reasons.
 
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