Medical OEMs Pan FDA for ‘Unclear’ Approval Process

The Food and Drug Administration is getting a black eye from US-based medical equipment manufacturers. A major percentage of these OEMs believe the FDA approval process is so unpredictable and delay-prone that they are instead heading overseas in droves to get foreign endorsement first, according to researchers at Northwestern University.

The medical equipment market represents a major growth area globally for electronics OEMs and component suppliers, but it is also one of the more difficult segments to break into. Regulatory requirements are stringent, manufacturing conditions must meet tough standards, and testing periods can often be as lengthy as for pharmaceutical products. However, the payoff can be hefty for companies that successfully navigate through the maze of requirements.

It's getting even tougher to play in the area due to tightening conditions from the FDA and the realities imposed by the litigious environment in which companies serving the healthcare industry must navigate in the United States. OEMs polled by the Northwestern University research team believe FDA requirements for medical equipment approvals are not only onerous — resulting in undue delays — but they also argue many of the conditions are unclear and unevenly applied, adding to the uncertainties already built into the system.

Their conclusion is that the procedures for getting FDA approval are very challenging and best avoided initially, at least until other foreign regulators have endorsed the product. This has created a lot of concerns about the exact focus of the FDA's 510(k) pre-market notification product review process as it applies to medical devices. The research found that two-thirds of medical device companies believe that products get faster approval in the EU region than in the United States. Respondents attributed the delays to unclear FDA guidelines and inconsistent implementation of the guidelines.

The report’s findings include:

  • Three-quarters of respondents (76 percent) found preparation requirements for a 510(k) submission to be uncertain or unclear; 72 percent felt that information requests from FDA reviewers went beyond the requirements established in guidance documents; and 59 percent reported no guidance documents existed for their devices.
  • During the past three years, respondents experienced changes in the lead FDA reviewer for approximately 14 percent of their submissions; of those, 60 percent felt the change negatively affected the product review.
  • More than two-thirds of all respondents reported that FDA requests had a significant impact on their financial resources.

The stringent FDA conditions may be warranted, but regulators and medical equipment manufacturers need to find common grounds for getting products approved faster where endorsement is necessary. In order to market their products internationally, medical equipment vendors must not only get US FDA approval but also seek the endorsement of at least four other major regulatory bodies across the globe. This tends to result in higher costs, which are then passed on to medical equipment buyers.

Clearly, the FDA is not going to compromise on quality, and the other international regulatory organizations won't yield to one single body. So, everyone involved in the process will have to find a middle ground that includes standardization to reduce waiting time and total cost to the manufacturers, even while protecting consumers of the finished products.

The FDA itself has acknowledged it needs to review the protocols involved, and the regulatory body appears to be striving to meet manufacturers' expectations. Yet the regulatory organization also must be cautious because of past criticisms it approved products based on flawed research done outside the United States. For instance, two studies exposed the shortcomings of FDA approval processes on heart devices (pacemakers and stents).

There is some good news from FDA for manufacturers. The agency has initiatives in place geared towards approval of medical devices within 150 days instead of the current average of 330 days. I want to believe that medical equipment makers will make a u-turn to the FDA for approval once the system has been overhauled. Do you think the FDA is too strict on medical equipment companies, or is this griping only about trying to establish a market advantage without complying with regulatory conditions? Let me know your opinions below.

17 comments on “Medical OEMs Pan FDA for ‘Unclear’ Approval Process

  1. Tim Votapka
    September 21, 2011

    Great subject! Medical device manufacturers have long-griped about the process for two basic reasons: the length of time and the clarity issue you mention. Yet, if the component world can succeed in the mil/aero market, there's no reason to believe it can't in the medical arena as well despite the landscape of protocols, documents and other traffic.

  2. Kunmi
    September 21, 2011

    The issue is that most medTech companies does not have much time to linger for approval on just one product line and if the approval time is delayed, many processes will be halted. These companies always put a lot of money and time into the process of approval and I believe they always want to get into the market as soon as possible. Whichever way it goes, it is obvious that healthcare delivery needs the contribution of electronic companies in order to meet with the current challenges.

  3. SunitaT
    September 21, 2011

    Do you think the FDA is too strict on medical equipment companies

    @Kunmi, I dont mind FDA being too strict if it doesnt compromise on quality aspects. Just curious to know why companies get faster approval in the EU region than in the United States ? 

  4. Tim Votapka
    September 21, 2011

    As I understand it, In Europe, a medical device needs to demonstrate it's ability to be safe while in the United States it must also be shown to be effective in treating a disease or condition. There is also a different reporting structure in effect. Third party agencies handle the approval in Europe whereas the FDA commands the approvals in the USA. 

  5. Parser
    September 21, 2011

    From my experience the quality requirements are needed, but to do the FDA approval process one has hire specialist(s) to handle all the submition papers and their content. 

    The language used is more like used for patents and all requirements are not clear. It would be nice to make that easier. 

  6. Houngbo_Hospice
    September 21, 2011


    Which one is safer for consumers? The european way of opproval or the american way? Or both have advantages and drawbacks?

  7. Kunmi
    September 21, 2011

    @Hospice_Houngbo. From safety perspective, there is no difference between the EU and US regulatory requirements. Though FDA believed that though approval time may be longer, thorough work has to be done to establish safety and effectiveness of these devices. Check out this related article for further information:http:



  8. Kunmi
    September 21, 2011

    @tirlapur The reasons are not far fetched. I will highlight some in bullet points:

    1. FDA's ensures “Safe” and “Effective” product while EU focuses on Safety

    2. FDA have tightened most of the reguatory oversights. So it is all the matter of “do it the right way” and “get it right the first time”

    3. EU approvals are handled by the third party unlike here in the United States where we have a powerful central agency, FDA

    4. It may also take months or years before clinical trial could start in the US and this is also needed for the approval of all submissions.

    I am sure there more reasons out there.

  9. Ms. Daisy
    September 21, 2011

    @Parser, it is both the lack of clarity and the lengthy paper trail that bogs down the process thereby delaying the approval process. Even with the specialists, the red tape makes the approval process cumbersome and frustrating.

  10. SunitaT
    September 22, 2011

    @Kunmi, thanks a lot for detailed explaination.That was really helpful. Do you think FDA will reassess its procedural norms so that it can catch up with its european counterparts ?

  11. Daniel
    September 22, 2011

    “It's getting even tougher to play in the area due to tightening conditions from the FDA and the realities imposed by the litigious environment in which companies serving the healthcare industry must navigate in the United States”

    Kunmi, what are the challenges companies are going to face due to this tightening condition?

  12. Ariella
    September 22, 2011

    @Ms. Daisy, yes, that's the function of bureaucracy.

  13. Tim Votapka
    September 22, 2011

    Part of the slow down in FDA approval will occur when a medical device must have what is called IFU documentation (Instructions for Use). This is where things get slow and laborious, particularly when you need to include specific instructions for the use and care of the device under scrutiny. If any part of that language is not clear, any part, your application gets stalled. You may be amazed at how specific the language needs to be. It keeps corporate legal and regulatory people busy for weeks at a time.

  14. Ariella
    September 22, 2011

    It's probably what keeps writers who specialize in this employed.

  15. Kunmi
    September 23, 2011

    It may appear as a game plan but in reality it is not. It is just “Quality ” based. Knowing fully well that the end users are patients in the sick bed. It is better to tighten up that loosen out, Safety and Effectiveness crown it all.

  16. Ms. Daisy
    September 23, 2011

    If I may add, it also increases the cost of healthcare delivery, which we all end up with. I still believe we can have safe medical equipments and supplies approved without so much red tape.

  17. elctrnx_lyf
    September 25, 2011

    its always a difficult process to execute but at the end this is actually to ensure safety. It is not a right way to point fingers at fda instead the organizations should work towards faster developments. As long it is similar regulations for all the companies it is still acceptable.

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