Hello - on this subject and in this e-mail thread there are a number of items to consider.
1) Finding prior 510(k) clearances:
- In some instances FDA has chosen not to post certain clearances known only to FDA, though this is rare.
- For some older clearances there are inconsistencies in spellings of the company name, product name, and other searchable data. One my 510(k)'s was the subject of such a problem that still persists today - from 2001.
- A researcher sometimes has to: (i) Use brute force and manually search, (ii) Download as much data as possible and perform wildcard searches, or, (iii) Ask for outside help from FDA, FOI Services or other external resources including an inquiry to FDA from outside counsel.
2) On the Topic of 510(k) Statements and Summaries:- Companies
do have a legal obligation to respond to all requests within 30 days.
- One commenter noted that FDA has not acted on this in some time which for a lack of better words is too bad - as it unfairly relieves some companies of legally-based disclosures. This unfortunately ties in with CDRH's recent pullback from issuing device-related 483's and Warning Letters.
- I am aware of a USA company and one its US-based subsidiaries receiving a Warning Letter for not responding to a 30-day request but that was many years ago.....
Respectfully, FDA should strictly enforce this as many of their current and future initiatives surrounding 510(k)'s are based on predicates, and predicates being less than 10 years old...... Unless FDA truly intends to change the 510(k) program to performance-based testing only which is a different topic altogether.
Thanks, Frank Pokrop
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Frank Pokrop CQA, CSQE, CPGP, CQE, RAC
Sr. Director, Regulatory Affairs
Carlsbad CA
United States
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Original Message:
Sent: 05-Dec-2019 09:13
From: Julie Omohundro
Subject: Predicate 510(k) Summary
I think a lot depends on what you imagine the purpose of the Summary and Statement, and of posting them, to be, if you have imagined them to have any purpose at all. But that's a muse for another day. Today, it's a moot point, because I can't imagine FDA actually enforcing this requirement. Not sure if it was ever intended to be enforced.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 05-Dec-2019 07:02
From: James Bonds
Subject: Predicate 510(k) Summary
It has been my experience that FDA will act on your behalf to prompt a recalcitrant sponsor to provide a redacted 510(k) based on their statement. However, I have not experienced them going to the extent of withdrawing a 510(k) clearance. I also have not had experience with a sponsor claiming the entire 510(k) is confidential, although there would certainly be grounds for a legal challenge to such a claim (but who would expend $$ and time pursuing such?). Personally, I believe that FDA should propose legislative action to eliminate the 510(k) statement as an option since there is no enforcement provision in the FD&C act, and require 510(k) summaries.
James
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James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
Original Message:
Sent: 04-Dec-2019 10:44
From: Anonymous Member
Subject: Predicate 510(k) Summary
This message was posted by a user wishing to remain anonymous
I have reported several companies to FDA for not providing their 510(k) copy (requested based on statement) or responding that the entire 510(k) is confidential.
FDA addressed the first one I reported, but none of the others. I have to think, if FDA is under resourced, then I would prefer they use the resources for other enforcement over noncompliance with the 510(k) statement.
"Noncompliance with the 510(k) Statement will be deemed a prohibited act under section 301(p) of the FD&C Act and FDA may choose to use its enforcement powers to obtain compliance."
Original Message:
Sent: 28-Feb-2019 15:57
From: Julie Omohundro
Subject: Predicate 510(k) Summary
I've never had cause to request a 510(k) statement, but at one time it was my impression that FDA was not inclined to intervene in the event that a company did not respond to a request. I would be interested to know a bit more...
Richard, when you say FDA holds really strongly to the 30 days, what type of action on FDA's part are you referring to as "holding strongly"?
Ginger, after you sent the letter to your FDA contact, did you get the Statement?
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 28-Feb-2019 08:10
From: Ginger Cantor
Subject: Predicate 510(k) Summary
Hello Mike,
To follow up on Statement versus Summary, a company filing a Statement instead of a public summary is obligated to provide WHOEVER requests a complete copy of their 510(k), at no charge, within 30 days. You do not have to ask FDA or FOI for it or go through them.
The 510(k) holder is allowed to redact proprietary information, trade secrets, etc. before providing. But they are not allowed to redact safety or efficacy data- technical data -that demonstrates the device was SE.
If I see 510(k) Statements filed by my client's competitors, I always request the complete 510(k). And bonus then, since I am not part of the client company, it is unclear to the 510(k) holder who is asking.
I have a standard letter template I shoot off. PM me if you want a copy. Sometimes though, the company or its listed contact has moved and the letter gets returned. Best to confirm the address on the clearance with the establishment/device listing database.
If they don't provide it, I will report them to FDA. I had one Japanese company send one page of it (cover page) along with a letter saying their legal counsel told them they didn't have to provide it. That letter went straight to my contact at FDA.
Just for education/competitive analysis it is fun to request them and see how others are positioning their device.
Good luck!
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 27-Feb-2019 11:13
From: Richard Vincins
Subject: Predicate 510(k) Summary
The company can choose to provide either a 510(k) Summary or a 510(k) Statement. A 510(k) Summary (as maybe seen in example on FDA website) contain the summary information about the device. A 510(k) Statement is a "promise" that information related to safety and effectiveness will be provided in 30 days. Usually do not recommend 510(k) Statement as FDA holds really strongly to the 30 days and must provide the file.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 27-Feb-2019 05:49
From: Mike Kilkelly
Subject: Predicate 510(k) Summary
Can some one explain why some 510k's have a summary and some only have a statement?
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Mike Kilkelly
Quality Manager
Galway
Ireland
Original Message:
Sent: 26-Feb-2019 10:43
From: William Coulston
Subject: Predicate 510(k) Summary
I apologize in advance if you have already done this but go to this link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm and search for the predicate. If it is recently cleared the 510(k) summary may not have been posted yet. There are also circumstances in which the 510(k) summary is not available due to some technological glitch. Finally, some postings only have a statement not a summary.
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William Coulston PMP, MS, RAC
Quality & Regulatory Manager
San Antonio TX
United States
Original Message:
Sent: 26-Feb-2019 10:23
From: Anonymous Member
Subject: Predicate 510(k) Summary
This message was posted by a user wishing to remain anonymous
I am trying to find a chosen predicate's 510(k) summary. The only comment I can find on the FDA search is that I can get the information on FDA internet. I requested it from FOIA a month ago, still no answer. I tried the company's Web site, but not there either. I'm preparing our pre-Submission and the summary would be of very great help.
Does anyone have any ideas??