In this worthwhile and quick read from my alma mater, Wharton health care management professors Matthew Grennan and Robert Town argue the FDA process is "pretty close to optimal."

By comparison, they believe the EU is "too lax."

Could make a lot of comments on this.
The expression "pretty close to optimal" is right for the FDA.
In my opinion that is.
For the EU, a very different story. They care about regulation, not patients.
When it comes to regulation they are way too strict and when it comes to patient welfare, they are way to lax. Completely on the wrong track. In my opinion.

Paul van Saarloos The study looked at just one type of device, and one that is already a reasonably well established technology. There are hundreds of other devices, that if analysed, would have given the opposite conclusion. I am aware of world leading technology that is kept out of USA because of the cost of approval and/or the fear the FDA approval will stifle innovation within the company. I do not know what is the cost to America of perhaps millions of operations performed each year with less than optimal equipment, and others not being able to receive treatment that is considered the standard of care in other parts of the world. But I guess it is significant.
Niether system is perfect, but just imagine what would happen to medical device innovation if the EU adopted the same process as FDA.

Pedro Fregoso There are many reasons why regulations in the EU appear to be lax compared to FDA regulations.

FDA has clear regulations and guidelines to help interpret those regulations, in addition, FDA is the only agency authorized to approve new Medical Devices for sale in the US, which in turn makes the approval effort for FDA overwhelming and sadly at times without adequate review.

Regulations for the EU are entirely different since they are governed by different directives [Active Implantable Medical Devices Directive (AIMD) Directive 90/385/EC, Medical Devices Directive (MDD) 93/42/EC, InVitro Diagnostic Medical Devices Directive (IVD) 98/79/EC], in addition to standards which can be requirements or simply guidelines for the approval process of new Medical Devices.

The fact that regulations for the EU are developed with inputs with committees from different countries, where each member (country) has its own perspective of what is important to include in the standard (or remove from the standard) results in a regulation that can be seen as more of a guideline than a regulation.

In addition approval for a new product in the EU can be obtained from a number of regulatory bodies which makes the approval process easier compared to the approval process for FDA.

A significant difference between FDA and the EU is the enforcement of these regulations after a Medical Device was approved, where FDA tends to focus on post surveillance and corrective actions; the EU tends to focus more on documentation review.

This, of course, is only my simplified view of the difference between EU regulations versus FDA regulations.

Stella S. NO, IT IS NOT TOUGH ENOUGH AND IT DOES NOT EVEN ADDRESS ALL THE CARCINOGENS AND OTHER DAMAGING INGREDIENTS IN FOOD, SKIN LOTIONS, SHAMPOOS, BABY FOOD, BABY SHAMPOOS, TOOTHPASTES AND OTHER CONSUMABLES!!!!!!!

Stella, we don't need to shout here …

To be very clear, the question posed was about "Medical Device Makers."

I think food additives & other synthetic ingredients need to be in a different forum.

My opinions: The FDA has the power for individuals inside the FDA to stop or delay an approval with not much easy recourse. A number of member in this group have been held up that way. I would hope the FDA has a way to minimize reviewers who have a chip on their shoulder. Myself, I would never PO the Golden Goose.

Other devices which are 510 (k) "me too" approvals can be dragged out and out, when in fact there is so much standardization after a product has been out a few years you wonder what is gained by requiring every submission to go through the same details in each approval all over again. After all, the 510(k) means it is just that, mostly routine. I recall the FDA is tightening up on this.

Wharton raised the issue on letting dangerous devices through the FDA process, which is a horse of a different color. Risk analysis and failure mode analysis ought to be put up front and center to show dangerous conditions can't occur or have adequate logic, safeties & warnings to stop dangers. No company wants to release a dangerous product as it usually means bankruptcy for small companies and even the sale or merger of larger companies.

Stella S. Burrell, I agree but it is just that I know people who have gotten sick from this and nobody says a word! I couldn't help saying that, why? The food additives the FDA allows are killing a lot of kids and grownups but mostly kids from cancer, etc., and I get really upset the minute I hear "FDA".

Stella S. RE MEDICAL DEVICES: You just have to ask the US Attorney to conduct an investigation as to what is going on with the top executives, CEO, COO, QA, QC, Chief Investigative and Inspection Analysts, at the FDA. Why does the FDA disregard true innovation from world accredited technical university students, entrepreneurs and inventors with ivy league graduate degrees and instead accept lesser quality and poorly designed medical devices from large companies who "lobby" (and you all know what that means) the FDA's top executives. There certainly seems to be something wrong going on at the FDA if we have so many inventors and entrepreneurs presenting new technology(ies) at our best Universities all over the country and the FDA does not even deign to take a look, much less do some independent scientific research of quite a few of them. The FDA certainly gets enough money from the government (from our taxes) to make it a valid point that they should look into innovation to try and save the lives of and/or improve the lives of people in the US and the rest of the world.

Pedro Fregoso Stella,

FDA does not ignore violations to regulations, or activities that that result in the release of products to the market known to harm individuals, as you can see in the recent sentencing of a former CEO (see link below for details)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm452987.htm

If you suspect of a criminal activity you can report it to FDA using the following link
https://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm

Robert Christensen In my experience it was cruel and unusual punishment for my 45 year, fully tested TMJ devices.

Stella S. Further re Medical Devices: They should ALL be made in the US so that we can monitor manufacturing and strict compliance with specifications. We ALL know $1.6 Trillion was lost to counterfeit in 2014, which figure is supposed to rise to $1.8 Trillion by the end of this year. 80% of all this counterfeit comes from China and I have 9-11 Government, academic, industry and scientific sources of data proving that 80% comes from China (available upon request bur posted in another group). So, again, all medical devices should be made in the US.

Stella, I agree that where foods come from should be marked. But many foods use materials from multiple countries and they don't identify the minor constituents or 'additives.' Lecithin is one, and I seem to recall 80% of the world's output comes from China. Lecithin is an emulsifier used in so many prepared foods it is endemic. Sorry, but I don't trust China, and the Obama trade bill will result in more food imports from China with minimal or no reporting as I've been told.

Stella S. Burrell, I agree with you re not trusting China re anything. That is why we should BAN ALL medical devices made in China. I also agree re Lecithin. Neither I nor anyone in our family eats anything containing lecithin, or soy lecithin or soy.

Stella S. I further believe and wish our government would take into account that for almost 4,000 years the Chinese culture teaches, demands and enforces their precepts that the individual does not matter, that the city does not matter, nor do the county or state matter, in Chinese culture only the country matters! Therefore, even though, as usual, they will smile and bow, saying they are fighting counterfeit and have all these international conferences telling everyone their new laws against counterfeiting, in reality, do they enforce their laws? Of course not! Given their 4,000 year old culture that only the country matters, can anyone believe China is really going to give up the 1.8 trillion (which has been growing exponentially for years) in money coming into their country by enforcement of anti-counterfeit laws?

Therefore, for the sake of all our lives, we should NOT allow any medical devices or anything else for that matter, to enter our country, which is "Made in China", lest we take an 80% chance it is counterfeit!

Paul van Saarloos This discussion has gone way off course. The Standard American Diet is probably the most unhealthy diet on earth today. The chinease, in general, eat far more healthily than Americans. The biggest diet related health problem today in China, is the growing acceptance of the Standard American Diet. Personally, I would avoid eating processed foods from either country.
If the American Diet is being used as an example of what happens when the government was too soft on controls and too heavily influenced by industry lobby groups, then yes, point proved!
From my limited knowledge of the subject, it appears the Amercian Diet starting going off course in the late 1960's, due to lobbying. With respect to devices, I am aware that lobbying is used to influence FDA;s decisions. In the areas I know well, it appears that FDA has not been significantly influenced by this lobbying in recent times. This is extremely important for regulatory controls.
There is no similarity between the control of foods in USA and the control of medical devices in Europe. Poor food regulations do not justify stricter, nor weaker control of medical devices.
On a side issue, often American technology is manufactured outside of USA solely to avoid FDA approvals until the company is financially established. Does this mean that this American technology should be avoided by Americans?

Stella S. Pedro, I can give you a LONG list of harmful ingredients, here are just a few:

* Sodium nitrite causes cancer www.cancer.org and is in a) processed lunch meats b) hot dogs, c) bacon, etc.) Instead of a chemical preservative, conscientious Natural brands use Celery Juice as a very effective preservative.

* For 250+ years Celery seed extract (in liquid or capsules) has been known to increase circulation, which common sense indicates would control Hypertension. People should see a Board Certified MD who is also a Herbalist instead of taking drugs, statins, etc.

* For 250+ years eating raw red onions and minced garlic with your food daily will get rid of respiratory illnesses like asthma, TB, etc. Everyone knows garlic is a natural antibiotic. I know of many cured of Asthma in 3-4 months just eating raw red onions with food. Instead, FDA lets patients be pummeled with drugs.

* Avocados lower bad cholesterol, raise good cholesterol, soften walls of arteries and remove 97% or more of plaque in arteries. NOW, FDA ALLOWS imported Haas avocadoes with a FUNGUS in them (I found out through an Agronomist), especially Del Monte but most brands have the fungus, so probably come from the same area. Yet, Adam Putnam, from the Department of Agriculture in our area, was advised and does nothing. The fungus is visible in thick strings seen longitudinally inside avocados. Even if the avocados are not yet starting to ripen, when you open them, they also have dark areas surrounding the seed and almost black spots in different areas of the avocado. Over a year and a half I personally wasted $520+ in bad avocadoes!

* Sodium lauryl sulfate (SLS) and/or sodium laureth sulfate (SLS) in toothpastes, lotions shampoos and even BABY SHAMPOOS (Johnson's Baby Shampoo has it) -- I DID report this some time ago, as a criminal activity to FDA, as this ingredient harms individuals, especially children. I also called your office and the woman answered "You are not supposed to swallow it". I responded with "Oh? Tell that to the mother of three small children, trying to teach them how to brush their teeth!" This was after I talked to a doctor in Internal Medicine, an Oncologist and others. Doctors all said SLS causes a lot of harm in human beings but that lotions, shampoos, etc. put upon the skin are much worse as they enter the skin through our pores directly into our system with no anti-bodies to stop them or minimize their effect. It is even worse in baby shampoos because babies’ immune system is not fully developed.

* "Modified" ingredients ARE in many canned, prepared and other foods.

* Fake sugars of all kinds have been linked to pancreatic cancer and are in 90% of all foods. This is from research in major US Research Hospitals and US Scientific Research Labs of Major Universities. High fructose corn syrup is in many things! Using regular cane sugar or fruit juice in small amounts is preferable (at least it is natural). Fake sugars are IN ALL DIET Sodas, DIET Foods, many regular yogurts and other foods! 70% of US population have a HS degree or less. Please read & look up labels!

* They used to give salt pills to soldiers in the desert to retain fat, sugar and water in their bodies. FDA allows a large amount of salt in EACH portion of canned, packaged, prepared and other foods. FDA will defend itself saying each item is assessed individually and that it has no part in the huge number of FAT (yes, not "overweight") individuals in the US. Most men over 45 look like they are going to give birth any second! Many people 45+ suffer hair loss because of ingredients FDA allows in foods, after said ingredients result in thyroid malfunction. Nobody should have more than 800-900 mg of salt per day, sea salt or not. Salt is salt!

* There is a VERY LONG list of all the bad things the FDA KNOWINGLY allows, causing people to get sick! In my opinion, that is depraved indifference and facilitation on the part of FDA department(s) to whom I reported this.

Julie Omohundro I think the regulation of medical devices is just a tad too complex to put before Goldilocks.

Paul, for a slightly different take on your last two sentences above, I see medical disposable devices in the respiratory field manufactured in China to avoid the high labor costs in the US.

It also goes on in diagnostics. Biosite in San Diego sold/merged with Alere and then Alere promptly moved most manufacturing East.

Stella S. Manifactured in China to lower costs but how can you guarantee there are NO counterfeit items?

The FDA tends to move the goal posts even for Class 1 devices. The FDA tends to comes back with queries almost at the end of the window period and then the clock starts again. The registration for a simple Spacer has taken ages and this is frustrating.

Julie Omohundro Stella, the only context in which "guarantee" has any real meaning is the guarantee of a seller to a buyer, as a term of sale. And the only thing it means in that context is that, if the product isn't as claimed by the seller, the seller will give the buyer a refund or a new item.

Counterfeit items will always be possible, regardless of country of manufacture. US manufacturers sometimes produce "counterfeits" of their own medical devices. Sometimes they know this, sometimes they don't. Sometimes they find out and recall them, and sometimes they don't. The best you can do is to implement procedures to reduce the likelihood of counterfeits; you can never eliminate them.

The useful question is what procedures have we implemented to reduce the likelihood that a product manufactured in the US is not a counterfeit, and what are the challenges in implementing those same procedures for products manufactured elsewhere?

Julie Omohundro Achal, the moving of goal posts is a predictable outcome whenever you institute a requirement for anyone to complete a task within a set period of time, without respect to the resources required to complete the task, nor the resources they have available to then to complete that task.

One difference between a review by FDA and a review by a Notified Body is that FDA's time constraints are often legal requirements, where the Notified Body's requirements is usually just a business requirement. The latter is more flexible.

The last time I dealt with a Notified Body on review of a design dossier, they didn't move the goal post, they simply ignored it, and completed the review in the amount of time it took them to do so given the content of the dossier and the resources they had available to them, and going through as many rounds of Q&A as necessary to get the information they needed to complete their review.

I can't speak to your specific situation, but often questions get asked late in a review period, rather than early, because the reviewer didn't have all the information needed to ask the questions earlier. As with any review, you ask questions, you get answers Sometimes the information provided to answer one question raises new questions.

Finally, the "clock" is the amount of time FDA has to review an application. It is not the amount of time it takes to get from submission to clearance. If you go into a review with this expectation, you are likely to be very disappointed when the process takes longer than expected, but that's not FDA's doing. FDA has been starting and stopping the clock for decades now; it is pretty much inherent in the process.

Julie, as much as we might thing our FDA, USPTO, etc. are staffed by super knowledgable people across the board, that simply is not possible. We have lesser trained people in lots of positions so that initial reviews are probably done by the less experienced persons in many cases.

I personally have run into some of these situations and just wind up with submitting the info requested for another 90 day review period.

Victoria Trafka The original article posted reviewed a very specific device and compared the regulatory process of two regions: the US and the EU. Perhaps in that one case studied, the process was regulation optimal? But the fact is that there are hundreds of thousands of types of medical devices with varying complexity of design and application. Even though there are a variety of device classes to account for some of these differences, it's unlikely that one process is optimal for them all....Or that the reviewers can apply the regulations equally to them all. I think that's why there are such vast differences in FDA responses to submissions. There's never one perfect answer to all questions, but there has to be some process to follow. The best thing for companies to do is to provide submissions that are complete and easy to follow and meet all of the published requirements. Help the reviewer understand your device and data. And always respond promptly to requests for more information, This will reduce questions and overall time required for review.

Julie Omohundro Bo, are you sure you meant to direct your comment to me? I don't think I've made any comment regarding the knowledge or training of FDA staff?

Julie my comment was just to the general issue of items that cause delays in task completion which you noted. I'm sure there are many causes that slow down FDA submissions.

Karl Schulmeisters I think Pedro's points are very well made. When we were building our ClearRoadmap product (https://ClearRoadmap.com ) we spend some time investigating how long it would take to build something similar for the EU, and we quickly realized that because of the multiple regulations its a much harder task.

The "harmonization" work that is going on is going to make this easier, but it still is going to be more difficult - in part because the EU contains both Napoleonic Code countries (France) as well as Common Law countries (Ireland) and reconciling the two procedural views of the law is non-trivial.

One of the biggest barriers is "First In Man testing". Because of the different rules on how "informed consent" is reached, in many cases it is easier to reach that first threshold of clinical results. But by some viewpoints, some of these approaches could be too lax.

Where I think the big issue is, is in the mHealth realm. And there I think the FDA is having a tough time. Their Fitness and Wellness Exemption Guidance has been grabbed upon by many to believe that they can just build an app and they will be exempt.

and yet we see the recent lawsuit against FitBit under FTC regulations (FDA sits within FTC) that allow citizens to bring suit - for a lack of accuracy in sleep data. Combined with the ACS study that found that out of 350+ smoking cessation apps NOT ONE actually offered best practices of the clinically proven best use of mobile technology - we are seeing an explosion of apps that really are medical devices, but are potentially venturing into the realm of the snakeoil the FDA was originally created to end

Julie Omohundro Joanne, that is interesting, thanks. Perhaps the difference is that there is only one FDA, and lots of Notified Bodies, so that the NBs don't get "watchdogged" quite as closely as FDA. In any case, circumstances surrounding that particular dossier were somewhat unique and complicated, with additional complications arising along the way, so that the standard review periods became almost meaningless before it was all over.

I guess my main point is that neither preparing nor reviewing a complex submission is equivalent to making widgets, and therefore the resources that will be required cannot be predicted up front, nor legislated into "making it happen." So when you legislate a particular timeframe, the results will be predictable. The clock will be stopped often, and new questions will pop up late in the review.