As originally asked by Mark Driscoll.

Could someone please share with me their experience with the 510(k) application. After having identified relevant predicate devices and built appropriate performance testing protocols to analyze the impact of new device characteristics – how does one gain access to the performance data of the predicate devices to which substantial equivalence is sought?

Jean Bigoney, RAC, CQE
Regulatory Affairs Specialist.
In that case it would have been within the FDA’s power to reject the J&J argument. Just because an applicant argues that a device is SE to an existing device doesn’t mean CDRH has to agree.

I suspect there were “other factors” at work. After all, how can you insist on clinical trials to cover the average time that an implant can reasonably be expected to last in the human body (15 years).

The science surrounding wear debris in hip implants had been there for all to read for at least 10 years by 2005. Either no one was aware of it or it was argued off the table.

Eduardo Alvarez
Technical Sales Manager – Lighting Division at PLASKOLITE
An article at the link below where the use of predicates in a 510(k) for the metal on metal hip replacements led to very bad results.

[http://www.nejm.org/doi/full/10.1056/NEJMp1109094|leo://plh/http%3A*3*3www%2Enejm%2Eorg*3doi*3full*310%2E1056*3NEJMp1109094/PlS-?_t=tracking_disc]

How should predicates have been incorporated to prevent the outcomes?

Bruce Gibbins
Owner at Bruce Gibbins Consulting
Another source of useful information is DSMICA. Its an FDA branch that assists mainly small manufacturers with questions pretaining to the FDA. You can be pretty candid with your contact as their only role is information….not review.

Glenn Neuman
Director of Scientific Affairs at New World Regulatory Solutions, Inc.
I’ve seen a few FOIs and they were useless because of redaction. You pay for a few hundred blank pages! So I’m not a fan. Just talk to FDA — they are “reviewing their reviewing” all the time (and raising the bar). Use their guidleines; even check the “CDRH Learn” videos on the FDA website. Contrary to many stories. FDA does want you to be successful!

All this about predicate testing — in the IVD world, if you are better than that predicate, it can work against you! A “gold standard” reference method (or an FDA-recognized consensus standard) is preferred, because comparison to a predicate that was compared to a predicate that was compared to a predicate causes “predicate creep.” Now, new technologies that are better than the existing gold standard create new challenges!

Richard Lippman
Industry Regulatory Consultant at R.E. Lippman Regulatory Pathways
The lead review of a given 510(k) may or may not show up in an FOIA request reply and there is no guarantee it would be included. Othr reviews or correspondences will not appear and would be redacted.

Jean Bigoney, RAC, CQE
Regulatory Affairs Specialist.
I am curious to hear from anyone who has obtained a 510(k) submission for a predicate device as to what you actually get. Do you get the original submission only or do you also get any correspondence that may have taken place between the lead reviewer and the submitter?

Richard Lippman
Industry Regulatory Consultant at R.E. Lippman Regulatory Pathways
Many devices have device specific Guidance associated with a particular device which outlines the kinds of performance data needed to satisfy FDA’s requirements to support substantial equivalence in a 510(k). Look for Guidance Documents on the Device Center link. One also can obtain the Summaries of predicate devices through the FDA website (see 510(k) Clearances). By knowing the product code for the particular device, or if you know a specific company and/or trade name, you can look up the predicate and review the Summary by linking on the Summary icon. Additionally, one can request a Freedom of Information (FOIA) directly through the agency although these requests can take an extraordinary time to be filled. The biggest downfall of this method is that all submissions are usually redacted from confidential and commercial information, so what you get may disappoint you.

Shrikant Gupte. Ph.D.
Inventor- Antibiotic MIC strips of paper having MIC values printed on both sides of the strip.
While showing SE with predicate device for 510(K) purpose, which link of FDA provides information about the nature of testing Lab and what approvals or certificates or recognitions it should have ? Can the study site be located out of US in country such as India ?

William Hasbun
CEO of HMD-USA
Hi Michael,
Do you know if ophthalmoscopes are exempted from the 510k under the new regulations?

Michael Tomasovich, MS RAC
Senior Regulatory Project Manager & Director of Business Development for Regulatory Affairs Associates (RAA)
In order to determine if a device is
exempt, a regulatory analysis should be conducted by looking at the
regulations
and product code.

Regards,
Michael

Michael Tomasovich, MS RAC
Senior Regulatory Project Manager & Director of Business Development for Regulatory Affairs Associates (RAA)
Jeff,

Devices that do not need 510k clearance are
considered 510k exempt and are normally class I or some class II devices.
If
a device is considered to be 510k exempt, the sponsor only needs to
register as
the device manufacturer before beginning sales of the device. The sponsor
should have conducted an analysis and determined the device is 510k exempt
and
created a memo to file showing this determination so that when FDA does
inspect
the facility it will be able to see the thought process.

Regards,
Michael

Jeff Wright
Vice President Thera Clean Inc.
Great! I will look into that. Thanks for the help Bo and Jean….still open for other input as well if anyone else out there has a different approach.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Jeff Wright: Less than 510 (k) would be a non-regulated item. You get into the world of zip ties and such that don’t contact the patient or if they do they have no medical effect. I don’t know how to determine what falls into non-regulated products, but I’m sure others will chime in with suggestions.

Jeff Wright
Vice President Thera Clean Inc.
Is there another FDA level approval that is not 501k? A more basic and simple approval for something that is a basic, non technical type of device? Thank you, Jeff

Bob Freytag
President at Introworks – Launching is like nothing else in business, I improve your odds of launching success.
This is an interesting discussion and I can offer some insight into the process. A group I’m part of, Medtech Resource Alliance, conducted a study on the 510(k) Process. You can download it here, [http://www.medtechresourcealliance.com/resources/MRA_510(k)_Study_1012.pdf|leo://plh/http%3A*3*3www%2Emedtechresourcealliance%2Ecom*3resources*3MRA_510%28k%29_Study_1012%2Epdf/RO1q?_t=tracking_disc]

The findings validated many of the concerns we hear about and knowing this information when you’re entering the submission process can help set appropriate expectations.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
After going through a 510(k), we chose to use an FDA regulatory consultant who does these filings and negotiations (yes the FDA negotiates) to get the 510(k) issued with the least amount of back and forth refilling with the FDA.

Learning with a consultant is bad enough on delays, but doing it by ourselves would have been a nightmare of multiple delays.

Michael Tomasovich, MS RAC
Senior Regulatory Project Manager & Director of Business Development for Regulatory Affairs Associates (RAA)
There has been a lot of discussion about using the FOI process, but there is a little better means to follow. We utilize a company called FOI Services. They routinely request copies of 510ks and maintain a database. While many of the 510ks are older they are worth downloading as they provide a baseline of testing and data required for clearance. We then create the proper clinical precise and testing outline and submit a presub/pre-ide meeting request to advise FDA this is the proposed testing and does FDA concur. If they concur we can move forward, if additional testing or data is required they will advise us and we can adjust accordingly. While adding in a presub or pre-ide meeting can add cost to the program, it does provide great value to the sponsor. The meeting will introduce the new technology to FDA, it will open a dialogue between the sponsor and FDA, and it will confirm the appropriate regulatory path to follow.

Michael Tomasovich
Regulatory Affairs Associates

Mark Driscoll, P.Eng., Ph.D.
Professor at McGill University: Research, Partnerships & More
Indeed this is turning out to be a very interesting discussion and I thank you all for sharing your thoughts. It is clear that one can expect a justifiably time-consuming process. It also appears to me that the FOI act may pile on additional delays. In light of uncertainty in one’s 510(k) application – what are your thoughts or experiences with the Pre-Submission Program?

Bruce Gibbins
Owner at Bruce Gibbins Consulting
This is an interesting discussion. One point that I hope has not been overlooked is the intent of the 510(k) process; that is that the manufacturer intends to place a product into the market that is substantially equivalent to the “indications for use”, “performance” or “composition” of a predicate(s) already in the market place. In my experience the testing conducted on the product must be adequate testing to ensure the safety of the device and its efficacy for its indications for use. Although I have supplied performance data comparing my devices to the performance of predicates it has largely been ignored by the FDA during the evaluation.…see more

Robert Christensen
Medical Consultant
As I read over your question about the 510k process it well reminded me of the battles we had to endure over my preammendment and predicate implants for the temporomandibular joint.

These were 1960 devices which because of agendas and corruption of the process by certain CDRH and FDA personnel were put through an egregious process of approval. This story might well be read by anyone in the medical device industry, today.

The book, just released by Tate Publishing is titled, FDA You Were WRONG! You may well find that the playing field is not always level. As I stated in the subtitle, Stopping Innovation Stops America.

I do think when one sees these times of injustice and corruption of the process, one needs to have the courage to stand up to the Agency and people so involved.

By the way, Jack Slovick, You are so correct. I appealed a decision tot the Commissioner and they did not answer for 8 months but instead issued a $630,000 CMP

Dr. Bob Christensen