Heh. I'm glad that Mr. DuVal isn't lobbying on my behalf. Talk about gratuitously and unnecessarily establishing an adversarial position, and insulting the lead decisionmaker. Wow.

At the company for which I work, our view is that the stronger and more effective the FDA's review process becomes, the greater the view among world medical device buyers that FDA regulation is a premier qualification.

Any sensible venture capitalist should understand how to make a nuanced distinction between the issues involved in achieving initial approval, and the market power that is accorded by that approval process being widely recognized as effective. In general it almost always will be more profitable to provide the resources up front to achieve approval and then have a strong sales position, than it would be to have a weak approval process and have potential customers look elsewhere for more-assuredly-safe-and-effective products.

Wow, there is alot of ignorance out there! The 510(k) process does not require medical devices to be safe and effective. The requirement is that they raise no new questions regarding safety or effectiveness when compared to their predicate(s).

The original predicates go back to 1976 and new predicates have been built from those (predicate creep?). Since the Safe Medical devices Act of 1990, the FDA has had a more free hand in requiring and asking for additional verification and validation (including clinical studies)if the reviewer believes that there are new unanswered questions regarding safety and effectivenes.

If this V & V requirement is used competently and effectively by the FDA, then there should be no question after the 510(k) clearance that the device is as safe and effective as its predicate.

The problem sometimes arises that, back in 1976, many devices were not very safe or effective. However, in many ways the FDA has raised the standard as predicates have evolved because it expects a level of performnace from new devices that the older predicates never could deliver. This can be provided with new technologies.

I believe that if the FDA uses the current system competently and updates its "When to File a 510(k)" Guidance Document (includes a decision process on determining when a significant modification of an already-cleared device has occurred) then the system will be doing what it is supposed to do.

Significantly, a problem that can arise is that the FDA may have little or no expertise in the new technologies that are improving device safety and effectiveness and do not understand how to review them. This has been solved lately by hiring outside consultants but not always.

Wow ---there are many regulatory methodologies utilized in other geographies that clearly support the safe and effective mindset. The STED from GHTF was even supported by FDA as a member of the study group and then there is the EU methodology that requires design controls (like FDA) and V&V (like FDA) and even clinical evidence. Amazing how people who don't understand the technical, clinical and regulatory processes are the decisionmakers.

Why we always blame the system? The 510k process was established to help the medical industry with historical proven facts. Lets talk about the corruption in the companies boards of directors, the lack of experience and knowlege in the review panels, and last, the users, which they espect a miracle or a law sue. The only way to know if a product is safe and effective is when is used. Not in a computer generate model with a theoric enviroment. Why do you think we do not have a flying car?

Chis,

There are so many problems with giving regulators free reign to request any additional dat that may gbe germain to the application. I have seen small device companies just pernicously attacked on their submissions. I applaud anyone that is hubris enough to take the challenge and reform the 510(k) process

Chris,
What do you call it when venture capital is not being spent due to the increased risk perception?
"disabled"? Hindered? I think destroyed is appropriate given the insult our industry could recieve.

I have to agree with Chris's comments and the 510K process of the past has its flaws. There are many companies that utilize the 510K process to not conduct clinical studies and to sell products off label. This is especially the case with vascular and some electrophysiology related products. I do think all and all the 510K process works well for most companies and products but there are a few device segments and companies that stretch their products to the 510K application when they should be IDE/PMA or special 510K. The FDA has gotten more vigilant recently with requiring some of these companies to submit special 510Ks requiring clinical (patient) studies and disallowing non-vascular indicated 510K applications knowing well that the product will be used for vascular uses; they then become PMA filings.

Nobody understood Barack Obama's qualifications for being President, but they elected him any. So appointments such as this are not at all surprising.

To say that the medical device industry will "will be destroyed" by proposed changes to the 510(k) process is a ridiculous assertion.