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Wednesday
Jul252012

Getting Your FDA 510(k) Medical Device Approved: How Long Does It Take?

How long does it take to get FDA approval for your medical device? About 90 days according to Palomar's CFO Paul Weiner.

Since we posted about Fairwarning's article on the RevecoMED LipoTron (or Lipo-Ex) there has been a lot of fiery back-and-forth in the comments and we've been getting more than the usual number of emails, including emails asking us questons about FDA approvals of medical devices in the US.

Read Fairwarning: The LipoTron 3000 (Lipo-Ex) FDA UnApproved $85k Massager

Now I have no real experience with any of the individuals or companies involved but one of the comments from the Fairwarning article caught my attention. It was this:

The company’s (RevecoMED's) initial application “wasn’t in-depth enough,” Rosen said, and the FDA repeatedly sought additional data. Finally, according to Rosen, “We said, ‘You know what, it’s not worth it.”

"It's not worth it"?

I would have thought that any business producing and selling cosmetic medical devices in the US would view FDA approval as being absolutely mandatory.

Perhaps the LipoTron guys know something I don't.

I haven't ever gone through the FDA approval process although I have many friends who have. What does it really take to get FDA approval for a medical device? How long does it really take?

The 510(k) process applies to most Class II medical devices sold in the US and a small number of Class I and Class III devices as well. Technically, the FDA does not "approve" medical devices; they "clear" them for sale. Once a FDA 510(k) number has been granted, it doesn't expire. However, you must remain in compliance with all FDA regulations to continue selling products in the US. The FDA may visit your facility at any time to conduct an inspection to ensure you are in compliance with the Quality Systems Regulation (QSR), 21 CFR Part 820.

Once you have submitted a 510(k) application, the FDA has 90 days to review it. This review does not mean clearance. During the review process, they likely will ask for additional information at which time the "clock" is stopped and then resumed upon the FDA's receipt of the answer to their questions. If a product is cleared, the FDA will mail the applicant a letter with an assigned 510(k) number that says they "have determined that the device is substantially equivalent to legally marketed predicate devices – and therefore, the company may begin to market the device subject to the general controls provisions of the Food, Drug and Cosmetics Act."

Essentially, when the FDA sends you this letter, they are not "approving" your device, they are saying that your device is substantially equivalent to the predicate device(s) selected in your 510(k), and which has already been cleared for sale by the FDA, and that you are now cleared to sell your device. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is cleared for sale in the US.

Once you have received your FDA 510(k) "clearance" letter, the final step is to complete the FDA device listing and establishment registration using the online FURLS system on the FDA website.

Read: The 510(k) Approval Process on the FDA website here

I did a quick web search and immediately found an MD&DI article that asked executives of medical device manufacturing companies to share their perspectives on the factors that are shaping the healthcare industry. What's of interest in this case is what Paul Weiner of Palomar has to say about getting FDA approval for new cosmetic lasers and IPLs.

Paul S. Weiner, CFO, Palomar Medical Technologies Inc. (Burlington, MA) from the article here

The industry we specialize in is cosmetic lasers used for permanent hair reduction, skin rejuvenation, photofacial treatments on vascular and pigmented lesions, tattoos, acne, etc. 

When we started selling our lasers seven years ago, we concentrated on the high-end market—that is, the dermatologists and plastic surgeons. We've captured a lot of that market. But our industry is similar to the way computers work: every few years you need to buy a new one if you want the latest and greatest technology. So every two or three years, the laser or light source technology that's out there becomes outdated, and the markets that we've been penetrating will usually step it up and buy the next generation of products. 

Over the last few years, we've also been penetrating down into the lower-end markets: the general practitioners, OB/GYNs, and even the spa and salon market. This market is worldwide and regulatory approvals for the devices are on a country-by-country basis and state by state within the United States.

The cost of the devices is also coming down, so they become a more affordable investment for smaller operations, such as spas and salons. The return on investment for these devices is about six months, so the financial benefits are obvious to potential customers. The whole industry has been driving in the direction of bigger markets, with lower prices, and better technology. 

"...even the spa and salon market"? Hmmm... I'll leave that alone for a second so that we can get to Weiner's comment about how long FDA approvals actually take for Palomar:

All of our devices are FDA cleared through the 510(k) process rather than a PMA process. These are noninvasive procedures; instead of taking maybe five to seven years for a PMA application, we do a 510(k), which generally takes about 90 days for FDA to review

Certainly over the last few years, there have been a number of changes with FDA. That's because as more and more devices are being developed and going through the agency, FDA is becoming more familiar with these devices and their overall safety. This allows us to get the devices through FDA a lot faster. And there are more predicate devices out there, which means you don't have to do as many clinical trials to prove the safety and efficacy you need to get the 510(k) clearance. 

With our first device, which was approved in 1996, it took us about a year to get clearance from FDA. Clearances now take about 90 days. 

Once you get past FDA, you're in good shape for obtaining regulatory approval from other countries. Europe requires the CE mark, which is not too difficult to obtain, especially once you've received FDA clearance. There are other areas of the world, such as Japan and China, where you need different approvals. Palomar has its international distributors work with their local governments to get the regulatory approval for the devices.

(bold emphasis; ours)

So if Palomar is taking just 90 days to get FDA approval for it's devices it doesn't seem that the process is so terribly onerous that smaller players couldn't get approval.

(Now undoubtedly the reason that Palomar is taking just 90 days is that they're using an iterive process that is using thier existing approvals to provide a springboard and get their approvals fast. I'm guessing that since RevecoMED's application for the LipoTron for fat-melting didn't have this history and they were being asked to provide more information about both safety and effectiveness. I'm also guessing that they were hoping to coat-tail on other fat-melting technologies but the FDA wouldn't just rubber stamp it and was asking for more information that would be expensive to produce.)

But the "it's not worth it" quote from RevecoMED's CEO seems to argue agains that. It seems to indicate that RevecoMed counted some beans and came down on the side of foregoing FDA approval and trying to sell the LipoTron as a Type 1 "massager" device once it became obvious that they weren't going to get 510(k) approval tout de suite.

That's what I find really strange; the fact that you would go to market without having already wrapped up your FDA approval. Sciton, Palomar, Solta or any of the bigger players wouldn't even think about selling a device having a Sword of Damocles hanging over it.

Reader Comments (4)

I guess if you have a real business you run it like a real business.

Around March 2008, the FDA told RevecoMED a Pre-Market Approval (PMA) would be required because there was no predicate device sufficient for their 510k submission.

07.27 | Unregistered CommenterPaige

After reading this article, which had some good points, I thought I would do a little fact checking myself before I accepted what I read. In reading the article, I have to agree that companies that are as large as Palomar can "spring board" their way into a 90 day approval process without much resistance. What had me most curious was how companies that were submitting new indications, or companies that were new to the FDA's lastest procedures, how are they fairing through this process? What can that process look like. I know a few FDA consultants, so I asked them and the information they provided me is below:

"The FDA has 90 days to review the original 510(k). If there are no additional questions the Sponsor/510(k) Holder will receive a letter of substantial equivalence. However, if the FDA has a single question they will issue a deficiency letter. The deficiency letter states the following:
 
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above. We cannot determine if the device is substantially equivalent to a legally marketed predicate device based solely on the information you provided. To complete the review of your submission, we require that you address the following deficiencies."
 
If the submitter does submit a written request for an extension, FDA will permit the 510(k) to remain on hold for up to a maximum of 180 days from the date of the additional information request.
 
You can receive up to two deficiency letters per 510(k) submission. You can ask for a 180 day extension for both deficiency letters. This means it could take up to 450 days (360 days of extension + 90 days for first review) before the FDA makes their decision as to the substantial equivalence of the device under review."

It was a nice article, but a little slanted so I hope this helps take away some of the mystery from the article.

A couple of things need to be clarified:

"Technically, the FDA does not "approve" medical devices; they "clear" them for sale."

-Yes, devices are "cleared" for sale based on the predicate device, but they are "approved" for use within the context of their 510(k) submission. Many devices, RF skin tightening devices, for example, are cleared for sale, but not approved for skin tightening. The RF predicate devices listed as equivalents are electrosurgical units, and they are described as a device that produces an RF generated electrical charge for cutting or coagulating. RF Therapy devices do not fall into this category of "approval," and they have been cleared for sale based on deception, or a lack of research on the part of the FDA. 510(k) and PMA is an integrity based system, and it takes oversight to actually crackdown on violators.

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