FDA Medical Device Fast Tracking PreRequisite Dangers
Tracking # |
FDA1949887 |
Submitted | Dec. 20, 2018 |
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Communications
From: John Ricker
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
Any documents that detail list of 510(k) predicate devices that have been recalled.
Any documents with a summary of 510(k) predicate device recalls.
Any documents that summarize 510(k) predicate devices.
Any documents that summarize product recalls.
Please prioritize these items in the order they are listed.
In the event that there are fees I would like to apply for a fee waiver. This information will summarize crucial public health information regarding medical devices that were fast tracked through 510(k) utilizing substantial equivalence and then shown that the predicate device was recalled. Due to substantial equivalence the medical device submitted under the 510(k) fast track will be at risk for similar if not identical issues. I.E. a new metal hip replacement is fast tracked under 510(k) utilizing substantial equivalence to a prior metal hip replacement. The prior metal hip replacement is recalled for product failure and leeching toxic metals. The new metal hip replacement was fast tracked under the substantial equivalence to the prior metal hip replacement that has now been recalled. This information about 510(k) predicate devices that have experienced recalls is very much in the public interest and will benefit the general public.
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.
Sincerely,
John Ricker
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
The FDA has been on furlough since December 21st. Any requests will be logged this week since we just reopened. More information about the government shutdown can be found on www.fda.gov<http://www.fda.gov>. The email box is for the FDA FOIA Liason. If you have questions about specific requests, please contact the person working on your request. You can find that information in your acknowledgement letter.
Regards
FDA FOIA
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From: Food and Drug Administration
Note: Do NOT reply directly to this E-mail
John Ricker John Ricker
Re: Confirmation # FDA1949887
In Reply refer to: 2019-602
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
510k list of recall etc
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: Any documents that detail list of 510(k) predicate devices that have been recalled. Any documents with a summary of 510(k) predicate device recalls. Any documents that summarize 510(k) predicate devices. Any documents that summarize product recalls. Please prioritize these items in the order they are listed. In the event that there are fees I would like to apply for a fee waiver. Th...
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 http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm. If you have any questions about your request, please call Claire B. Stansbury, Information Technician at (301) 796-8979 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
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Fax:(301)827-9267
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E-mail: ogis@nara.gov
Fax: 202-741-5769
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: John Ricker
I am appealing your constructive denial of my request filed 1/9/2019.
It has been over a year without any communication from the FDA. I have frequently sent in communications and requests to check on this but have received no reply. The statutory deadlines have all been significantly passed.
I am requesting IMMEDIATE release of all requested records.
John Ricker
From: Food and Drug Administration
Mr. Ricker,
Your request is open to CDRH for processing, I have copied Jasmine so she can provide an estimate of response.
When contacting FDA regarding your request always use the file number and your file number is 2019-602.
Regarding your appeal for constructive denial, I can send your appeal to HHS to log, but HHS and DOJ have determined that failure to respond is not an appealable issue and they remand the request back to FDA for processing.
Please let me know if you would like your appeal logged.
Regards,
Katherine
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From: Food and Drug Administration
Good Afternoon Mr. Ricker,
I attempted to call you to see if we can discuss your request. Are you available any time tomorrow to discuss your request?
Thank you
Jasmine Howard
Jasmine Howard
Branch Chief, Division of Information Disclosure
Center for Devices and Radiological Health
Office of Communication and Education
U.S. Food and Drug Administration
Building 32, Rm 4204
Tel: 301-796-5950
jasmine.howard@fda.hhs.gov<mailto:jasmine.howard@fda.hhs.gov>
[cid:image011.png@01D51548.FF468D20]<http://www.fda.gov/>
[cid:image012.jpg@01D51548.FF468D20]<https://www.facebook.com/FDA> [cid:image013.jpg@01D51548.FF468D20] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image014.jpg@01D51548.FF468D20] <http://www.flickr.com/photos/fdaphotos/> [cid:image015.jpg@01D51548.FF468D20] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: Customer Service <https://www.research.net/s/cdrhcustomerservice?ID=3031&S=E>
From: John Ricker
Hi Katherine and Jasmine,
Yes, please log my appeal.
Jasmine, I work in the mortgage industry so my days are a bit... hectic at the moment. I’ll be free around 12-12-30 or after 5 tomorrow
I’d prefer email if possible,
Thanks,
806-891-2076
John Ricker
From: Food and Drug Administration
Good Morning Mr. Ricker.
Would you be able to provide me additional information regarding your request? For example, Do you have a specific device or manufacturer you are requesting this information about? Do you have the recall number for reference?
Are you looking for the entire 510(k)s or just the clearance letters? Any information would be very helpful into completing your request.
Thank you
Jasmine Howard
Branch Chief, Division of Information Disclosure
Center for Devices and Radiological Health
Office of Communication and Education
U.S. Food and Drug Administration
Building 32, Rm 4204
Tel: 301-796-5950
jasmine.howard@fda.hhs.gov<mailto:jasmine.howard@fda.hhs.gov>
[cid:image011.png@01D51548.FF468D20]<http://www.fda.gov/>
[cid:image012.jpg@01D51548.FF468D20]<https://www.facebook.com/FDA> [cid:image013.jpg@01D51548.FF468D20] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image014.jpg@01D51548.FF468D20] <http://www.flickr.com/photos/fdaphotos/> [cid:image015.jpg@01D51548.FF468D20] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: Customer Service <https://www.research.net/s/cdrhcustomerservice?ID=3031&S=E>
From: John Ricker
Hi Jasmine,
I’m not inquiring about a specific device or recall number. I’m interested in any 510k where the predicate device has been recalled but not the 510k itself just it’s predicate.
I’m also interested in tracking delays between the predicate device getting recalled and the 510K device getting recalled.
Thanks,
John
From: Food and Drug Administration
Thank you Mr. Ricker,
I am looking further into your request. I will reach out to you if I need any further clarity of your request.
Jasmine Howard
Branch Chief, Division of Information Disclosure
Center for Devices and Radiological Health
Office of Communication and Education
U.S. Food and Drug Administration
Building 32, Rm 4204
Tel: 301-796-5950
jasmine.howard@fda.hhs.gov<mailto:jasmine.howard@fda.hhs.gov>
[cid:image011.png@01D51548.FF468D20]<http://www.fda.gov/>
[cid:image012.jpg@01D51548.FF468D20]<https://www.facebook.com/FDA> [cid:image013.jpg@01D51548.FF468D20] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image014.jpg@01D51548.FF468D20] <http://www.flickr.com/photos/fdaphotos/> [cid:image015.jpg@01D51548.FF468D20] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: Customer Service <https://www.research.net/s/cdrhcustomerservice?ID=3031&S=E>
From: Food and Drug Administration
My apologizes, I have a few more clarity questions for you. In your original request, you appear to be the seeking 510(k)s for new metal hip replacements. Would you want us to stick with the type of device you stated in your request (metal hip replacements) whose product codes are OQG, OQI, OGH, MAY and KWZ? Are you now saying, you are now seeking any 510(k)s where the predicate device has been recalled? If so, is there a specific timeframe you can narrow your request to?
For your convenience, enclosed is a link to the product codes database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
Thank you so much for your clarity,
Jasmine Howard
From: Food and Drug Administration
Thank you Mr. Ricker for our short conversation today. I believe I understand what you are looking for now. Because it would be quite a voluminous request, can you please limit your timeframe?
Much appreciated
Jasmine
From: John Ricker
Sure, go ahead and limit it to 2018-present for the recalls and let me know if that’s still too much,
Thank you!!
From: Food and Drug Administration
Thank you. I will update your request and I believe you will hear from either Katherine Uhl or the appeals office in regards to your appeal. They we get back to you with an approximate timeframe.
From: Food and Drug Administration
Dear John Ricker, Please see the attached acknowledgement letter for information concerning your FOIA matter. The tracking number for your appeal is 2020-00258-A-PHS. For status updates or other inquiries, please contact our office via email or call (202) 260-6933. FOIARequest@psc.hhs.gov Sincerely, Jacqueline Trent
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Dear Mr. Ricker, Attached please find a Constructive Denial Remand Letter for your appeal no. 2020-00258-A-PHS. If you have any questions regarding your FOIA matter, please e-mail our office. Sincerely, Elizabeth Webb FOIA Specialist PHS FOIA Office Email: FOIARequest@psc.hhs.gov Phone: (202)260-6933
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Dec. 20, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1949887.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good afternoon,
Thank you for reaching out regarding your FOIA appeal. The HHS FOIA office had closed your appeal on October 1, 2020 and remanded it to the FDA FOIA Office for completion. You may contact the FDA FOIA Office at 301-796-3900 for further updates regarding the status of your request.
Thank you,
Liz Webb
Government Information Specialist
FOI/PA Division
Office of the Assistant Secretary for Public Affairs
U.S. Department of Health & Human Services
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From: Food and Drug Administration
Mr. Ricker:
I've just be assigned your request(attached) for processing. After review of your request and meeting with our program offices in order to respond to your request we concluded the following:
1. FDA would have to create new records or perform analysis of existing records.
2. Your request requires a large number of documents that require the deployment of a substantial amount of agency man-hours to search for and compile.
As a result, under FOIA regulation 45 CFR 5.1(a)<https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-5> The FOIA does not require agencies to create new records or to perform analysis of existing records. In addition under 21CFR20.50<https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=20.50> we have concluded that your request would result in being overly burdensome. Due to the records being voluminous it would be an unduly burden and interfere with the operations of the Food and Drug Administration.
In order to satisfy your request without disproportionate adverse effects on agency operations. We recommend you use the Medical Device Recalls<https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm> and 510K Premarket Notification<https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm> databases to find the records you're seeking.
Please feel free to contact me if you have any additional questions.
V/r,
Ms. Stanza Ludgood
Branch A Team Lead
Division of Information Disclosure, (DID)
Office of Communication and Education, (OCE)
Center for Devices and Radiological Health, (CDRH)
Food and Drug Administration, (FDA)
301-796-2922
Stanza.Ludgood@fda.hhs.gov<mailto:Stanza.Ludgood@fda.hhs.gov>
[cid:image001.png@01D97751.63672260]
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Excellent customer service is important to us.
Please take a moment to provide feedback regarding the customer service you have received:
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