David Wogahn
President, AuthorImprints; Author, LinkedIn Learning; Specialist, SEO for Books; Taster, 120 different whiskies
Joe is thinking about creating an eBook based on this topic. Would you like to be featured, or learn more? If yes, email me directly at david@sellbox.com with the subject line "Medical Devices Group" and I'll send more information. Thanks!

Aviva Lev-Ari, PhD, RN
Scientific & Biotech e-Publisher and Venture Funding at Leaders in Pharmaceutical Business Intelligence (LPBI) Group
I agree, a worldwide Global certification would represent Progress in Technology. Aviva Lev-Ari, PhD, RN

Lorenzo García
CEO at Novaelectronica Iberia, SL
From a safety point of view discussing about FDA clearance and CE marked products have no sense at all. Here in Europe the FDA clearance is not relevant and it's not recognized by ec authorities. In fact independent countries are free to stablish their own rules based on common directives. In Spain, for instance, there are special requirements not applied in other countries which are submitted by under the same directives. Can we say that a spanish CE marking has higher level of credibility compared to other European assessment? I don't think so. Considering that All medical products are manufactured to be used by Humans... why isn't there a worldwide Global certification ?

Neil Armstrong
CEO at MeddiQuest Regulatory Affairs Limited
After 20+ years working with both systems, I would say both systems are en masse about the same: CE is frequently marginally easier for a totally new product or but in general requires more clinical data. The CE system is often derrired for medical devices because it applies to other product types, this is fundamental misunderstanding: traffic laws are basically the same on the open road and outside a school but requirements ( speed limit, parking restrictions etc) and enforcement are very different. So too with toys and medical devices ... But also I should not detract from the stringency of toy regulation - some years ago we had an unusual combination product under both these directives ... It was the toy directive we found harder to meet because of the material restrictions!

Mario Martinez
Managing Partner at Tecnix, LLC
Joe, My understanding is that there are certain advantages to CE marks, at least in Latin America. One advantage of CE marks is that in some countries CE marking allows for 5 years between local registration renewals while FDA clearance is only 2 years. Another advantage to the CE mark is that registration in some countries require facility inspection reports and FDA will not inspect OUS facilities unless they are producing PMA products or there has been a problem. That said there is a significant advantage to a PMA approved product sold in the U.S. as it provides a level of legal protection and a barrier to entry. In any case it is mostly a work of "documentation archeology" if documentation is completed properly for a 510K device CE marking is simple and the reciprocal is also valid. So the argument of FDA cleared being better is in my opinion not valid and may possibly be worse for some export markets.

Peter Rule
Executive Chairman at Life Detection Technologies
I think we need to remember that CE approval has evolved to include a Clinical Evaluation Report (CER) starting in 2010. And, in 2011, the notified bodies were quite used to the CER and pretty good at determining if the underlying product had sufficient data for approval in the intended use. With the addition of the CER, the CE process has been strengthened nicely, responsive to criticisms in this string.
The 2nd point regarding both approvals is that they do not in and of themselves create a revenue line. Persuasive clinical evidence of benefit do.

Anne-Marie Fuentes
Quality, security, environment and regulatory affairs Director
To complete Marcus' opinion, to obtain CE marking, you can proove that your medical device respect the directive using scientific litterature : it means that you can explain your medical device, how it is built and how it functions. Then you must explain with medical devices are similar and then you can use results of studies that are maid on similar medical device. I don't know very well FDA process (I never had to use it) but I think that there is something equal in FDA procedure because you need to compare a medical device existing on US market with your medical device. The objective is the same, the method a little different and in CEE, we try to re-use clinical results and so save time and money. It's not smile but cost less money than having clinical trial. Also, this procedure can't be use alone for all classes.
The difference between CE marking and FDA is that the CEE Directive have been written in 1993. At this time, medical devices are existing for several years and each state member has his own exigence. In 1993, all those points of vue were put in one text. And this text must have taking care about the situation of each state member. This text try to put the same high exigences in each state member.
In US, all your states used the FDA rules for several years. And FDA is the only reference. So FDA choose the rule and check how it is applied. It seems more simple. In fact, I think that CE marking will change and will become something like the FDA but it will take few time. So I think that there isn't one way to obtain the same objective (Patient security guarantee) and CE marking is just a younger organization than FDA. It's just a different point of vue, where the manufacturer is responsible. CE need now more control because all the manufacturers are not responsible persons, as history shows us recently.

Marcus McMillan
Project Manager at Gilead Sciences
From my experience in Class II medical devices there is a distinct difference between CE marking process and 510(k) or other such FDA clearance. CE marking typically requires submission of documents/evidence supporting the criteria in the guidance documents. I know of companies that have been granted approval without the full completion of real-time stability studies and clinical studies. A term i have heard used with CE marking is a self declared submission of evidence.
Any FDA clearance requires much closer scrutiny of the evidence supporting the product. This evidence is then reviewed which often leads to several back and forth episodes before the submission is to the satisfaction of the FDA.
Again, generally speaking and from my own experience, time time, effort and detail required for an FDA approval is significantly greater than for CE marking or for ISO 9001/13485. Again, this is only with Class II medical devices.

Tim McCoy
Medical Devices Consultant and Contractor
Having gone through both systems as an engineer, I do not rate either system as better.
But having said that, it seems that, again referencing my own experience, the FDA system is more linear, whereas the "CE" can be obtained by various methods.
The "CE" mark reason for existence is different that FDA approval. I have always felt the FDA system should take precedence, and it should be made equivalent to the "CE". But then what would become of all the private agency's that grant the "CE".

Terry Morris
Business Development Director at MYoroface AB
A related issue (but not really answering your question I know) is how often we find that US companies feel that they can't start marketing a device globally until they have FDA. This isn't true at all. Obviously the global manufacturers already know this, but it's surprising how many smaller US companies - especially start ups - don't. Let me know if I can help on this score.

DR. MICHAEL WARD
Exploring the vast potential of medical devices.
Two comments: First to John and then to Jean.

1. To John. I don't believe that FDA determines safety and effectiveness per se but merely judges what is presented and how data were obtained. It is the medical device companies that must show FDA that their new device meets standards for safety and effectiveness. Some of those standards are from such organizations as ASTM or medical associations, healthcare agencies etc. It is a collective process by which acceptable standards are determined. FDA's role is to judge if these standards have been met, if the CFR and FDA guidelines have been satisfied, and if the Sponsor has carried out its various processes and functions in robust fashion. Physicians/hospitals are in no way equipped to pass judgement on the overall safety and effectiveness of medical devices. They are, however, quite well prepared to offer anecdotal feedback on whether a medical device meets their practice standards and needs. Collectively, as a group of experts in a focused medical society, they may act, in concert with FDA to publish practice standards and disease-specific requirements. An example is:

Calkins H, Chair, Kuck, KH, Co-Chair and Cappato, R, Co-Chair. (2012) HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design. Heart Rhythm 4:1-58.

FDA will use such publications in their review of applications to set the bar for acceptance. Though some might then blame FDA for being too harsh, the actual source of new standards actually originates with groups of physician experts who wish to play a role in deciding how medical devices might enter the market.

Another example is found in the a 2011 publication in the European Heart Journal, giving a report of a policy conference of the European Society of Cardiology - "Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform"

2. To Jean:

I do not believe that the process of substantial equivalence impedes any effort to radically improve medical devices. There are many ways to demonstrate substantial equivalence and I have seen some very imaginative comparisons that seem to satisfy FDA. When the first interventional devices hit the market, they used open surgical devices as the predicate devices. If there is a great breakthrough in medical technology and it is likely to have a huge positive impact on medical practice and patient outcomes, there is no way FDA will impede approval/clearance....unless the application is flawed. The problem often is that some companies do such a poor job of demonstrating safety and effectiveness that the application process seems to take forever. I recall a LVAD, developed by Novacor (now World Heart) that required the best part of 20 years to get PMA approval. In that time, there were at least 3 clinical trials - not the fault of FDA but of the leadership that more than once changed the device significantly to throw the development process back to square one. Extreme example? absolutely! However, Jean, I fully support your views on reimbursement.

Jean Bigoney, US-RAC, CQE
Regulatory Affairs / Materials Engineering
Quoting Dr Ward: " It appears to me that most new devices are of the "me too" type and don't really generate radical improvements to medical therapy." Well what do you expect given an approval system that is based on the concept of "substantial equivalence?" But really, the FDA approval system isn't what is keeping novel technology from patients, it's the reimbursement system. Getting FDA approval for a mildly novel device isn't even that diffcult nor does it take that long. The hard part is getting a reimbursement code from CMS - that can take several years. They have a catch-22 built into the system: to get a code, you need 3 % market share. But without the code, only those with private insurance can afford it.

John Spashett
Teacher of Mathematics
I generally agree with Dr Ward, however I think there is one important part of his post that is incorrect.

"b) That new devices are equivalent to or better than what is currently available."

Implies that the FDA have a godlike foreknowledge of every aspect of medicine as practiced by every clinician. However, the truth is that the best people in a field do not work forthe FDA but in hospitals and these are the only people who are fit to judge if the majority of new devices are better than those that came before. In that situation the FDA has to ensure the devices are safe and are comparable to past devices in performance (when that can be judged). Only whent he devices are released into the marketplace and the true experts vote with their cash do we find out if there is a place for the new device.

Obviously in some simplistic cases the FDA can judge if a device is worse. For example a blood glucose monitor that is wildly less accurate or precise than others in the market and has no counterbalancing merits.

DR. MICHAEL WARD
Exploring the vast potential of medical devices.
Phil's point about long review times denying patients an opportunity to reap the benefits of device use is certainly valid on a conceptual basis but, in most circumstances, seems to be more fiction than fact. The crux of this argument lies in how many prospective medical device candidates will actually make a significant impact on therapeutics and patient outcomes and how many will just add to the clutter of an already met clinical need. It appears to me that most new devices are of the "me too" type and don't really generate radical improvements to medical therapy. Yes, they may have a vew tweeks or nuances that are intriguing to physicians (it is often said that medical devices users are like children in FAO Schwarz, when a new action figure makes its debut) but, in the end, risks and benefits seldom vary unless a new technology platform emerges or a new device positively addresses a serious risk or therapeutic need for the first time.

My take on the evolution of medical devices is that the majority of improvements are small, incremental and of little consequence on a one-at-a-time basis; however, the collective changes within a certain class of devices do add up such that a comparison of therapeutic approaches and outcomes in 5 or 6 year intervals would show marked improvement. In the true interests of protecting patients, I think FDA can well afford to take the time necessary to ensure two things:

a) That few if any disasters reach the marketplace.
b) That new devices are equivalent to or better than what is currently available.

On the other side of the debate, I have seen instances where no acceptable therapy is available and FDA has given early conditional approval/clearance or expedited the review process. In these instances, it might be argued that the patient community suffers unjustly every day that badly-needed device remains unavailable.

Phil Triolo PhD RAC
Principal at Phil Triolo and Associates LC
From a regulatory perspective, there is no wording in any regulatory requirement that I am aware of that would not allow a medical device manufacturer to opine that the "FDA is better" than CE Marking as a result of technical file/ design dossier review by a Notified Body. As to whether or not this confers any marketing advantage, that is not a regulatory issue.

"My product is "better"" is the kind of wording that can get a manufacturer in trouble if the manufacturer does not have data to support the claim.

A bit off-topic, but relevant, is a discussion of benefits and risks. The FDA is quick to point out instances where it hasn't cleared/approved a device which is later shown to pose an unacceptable safety risk... But when there is a delay in the market introduction of a device with an acceptable benefit-risk profile, patients are denied the benefits afforded by device use. The improved quality of life or increased life expectancy associated with device use is denied while any regulatory agency is reviewing the device. Benefits of device use are more difficult to assess and quantify than patient deaths or fractures of implanted orthopedic devices, but in many instances the real negative effect of prolonged review times or overly cautious regulatory determinations is the denial or delay of the ability of patients to reap the benefits of device use to address their clinical need.

John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Re: Joe's question -- Marketing to make distinctions between FDA and CE-marking benefits is not recommended. Astute clients can discerne an implied bias, from individuals (Sales/Marketing) generally not qualified to render such opinions. Most marketing books talk about stressing your company's / product's strengths, and not talking down the competition; and most of us react that way in a selling situation.
Re: the discussion string -- I agree w/ much of what has been stated.
CE-marking involves two basic issues: 1) having a functioning / documented QMS (documented Quality Management System) under ISO 9001/13485, and 2) meeting "essential requirements" under the MDD and applicable standards; both of which are verified by a notified-body hired by the manufacturer. From personal experience on vendor audits, I have to question many "reputable" ISO audits, in that when I do a cGMP-compliance audit, on companies that have ISO QMS certification, I frequently find serious areas of non-compliance, e.g., not following SOPs (which the FDA would find results in "adulterated product"). My experience over many years is that, in general, the US FDA cGMP compliance audit is usually more stringent that a comparable ISO audit (yes, this has resulted in many professional 'disagreements'). True, neither audit can find all the problems in a company, but I tend to put more faith in a company that's had a U.S. FDA cGMP audit, over one with an ISO 13485 audit, but would almost always rank both over one having no formal QMS.
As far as meeting applicable standards, I see both the MDD and the FDA having more in common, with more joint recognition of the same standards. Statements such as "UL approved" usually apply to meeting electrical standards such as ground leakage, et al, which are replicated in similar ISO, et al, standards, as well as AAMI, ANSI, EN, IEEE, ..., rather than compliance to a QMS, which is what CGMP (21 CFR 111, 210/211, 820), ISO 9001 / ISO 13485 delineate.

Renay Ebelle
Senior Executive at EDE Pharmarceuticals
"Is gaining FDA clearance more stringent than obtaining a CE mark?": As always, it is demanding to get FDA clearance than the CE mark but this is essentially from a mental stamina than content as both applications usually require similar information for clearance.
"Well, our device has FDA clearance and the competitor only has a CE mark," the clear inference being FDA clearance is "better" so you should buy my product instead": I will avoid such marketing ploy as it may back fire just because it is not accurate. A well informed customer will read through this and may see this as disparaging negative ploy. The merely difficulty in securing a 510k clearance within the regulatory time frame is due to the lack of resources to review applications and the inconsistent, non-subjective approach within the agency to do so effectively. Thus the current overhaul of the 510k regulation. I hope this helps.

Jeff Hover
Senior Executive at PiSA Ventures
"good enough" implies that the intent of the regulatory process is to convey some form of approval when it in fact does not. Possessing a CE mark or 510k is merely an indication that an organization is compliant with the requirements to permit legal marketing of their device as a medical device within the given market. "Good enough" is never a term that should be used in the medical device industry. Striving to deploy the safest, most effective medical devices at the BEST cost deliverable is the mantra of the successful medical device company. How would we feel if the health care practitioner we visit gave us "good enough" care? I dare say that none of us are willing to settle for "good enough" when it comes to the service level and performance we expect from others so to ask if it is acceptable to give "good enough" to customers is a very poorly designed question and regulatory compliance is a given, not a strategic advantage.

Sales reps should be discouraged from conveying that the 510k is anything more than letter of determination that the medical device is substantially equivalent to one already in the market or one manufactured prior to 1976 - it is not an FDA approval of the medical device. The most effective FDA documents for sales reps to use are any warning letters that the company's competitor has received from the FDA - these are public information and can give the customer an idea of quality difference between the company and its competitor.

David Freilich
Senior Medical Science Liaison and Senior Team Trainer at Impax Pharmaceuticals
I would point back to camilla's post having had similar experiences. In this case the items in question were actually manufactured in Germany.

milind pathak
Owner Pathak Consulting... Consultant for TPS,ISO,EMS,OHSAS,CE,VE,IE
As unbiased person I would say that any regulation is OK as long as ethical implementation is in place and followed keeping in mind the intended use of the product and customer interest. Any regulation can be temporarily ignored by the manufacturer if there is malicious intention but such act ultimately will lead to breach of trust of the customer and long term ill effects will definitely ruin such manufacturer.

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