MINNEAPOLIS – In what the IBF Med-Tech Investing conference held here last week billed as a fireside chat – complete with a virtual log fire on two big screens – Don St. Pierre, associate director for policy and operations at the Center for Devices and Radiologic Health's (CDRH) Office of In Vitro Diagnostic Device Evaluation and Safety (OVID), discussed potential heightened barriers to the use of the 510(k), including the need for more scientific data for this regulatory pathway.

Mark Duval, president of DuVal & Associates (Minneapolis), asked St. Pierre, if all the changes coming about with the new administration are having any sort of negative impact on staff at FDA. St. Pierre, who has extensive experience at the FDA first as a field engineer testing medical devices at CDRH laboratories and then as a branch chief and deputy director of the division of clinical laboratory devices and deputy director for new device evaluation in the office of OVID, said "nobody likes you anyway" when you're a regulator, and while changes are coming because of new policy priorities by the Obama administration, "most of the changes will, I think, reinforce what's already there."

Duval asked St. Pierre if his staff appreciates the FDA credo to protect and promote, and interestingly, he said most staff would say their mission is to promote and protect. "We wanted to emphasize the promotion of public health. It's getting good product out into the market quickly."

Duval said while he was encouraged to hear St. Pierre's take on the mission of FDA, he said that recently when he has gone before staff from the agency on behalf of clients, he felt he was constantly reminding them of their responsibilities. He said that when he brings in confirmatory clinical data on behalf of a client for a potential 510(k), he invariably finds that the staff starts with a commentary of the clinical trial data as if it's a pivotal clinical trial for a PMA. I find that problematic."

St. Pierre asserted that it's not a given that all 510(k)s have to have data. "Last time I checked, more than 85% of 510(k)s don't have clinical data," though he allowed that in vitro diagnostics(IVD), for which his office is responsible for, do mostly have clinical data, but in that industry there are many repositories for banked specimens "so it's a little bit easier."

One of the biggest problems that St. Pierre said he sees with 510(k) submissions is a sponsor's lack of willingness to be completely honest about the company's true intent for a product up front. He said he can sense it when they come into the room. The sense he gets is "I don't want to tell you exactly what I want to use this for because if I do then you're going to start to ask all sorts of questions."

Starting with less than complete candor can be quite detrimental to the company in this position said St. Pierre. He suggested that companies should enter into discussions with FDA before they even make their 510(k) submission so that everyone is on the same page and the agency can do a better job of understanding what the product patient population is going to be. It's better to work on those issues on the front end than waiting until one gets before a panel and getting shot down then on their application.

St. Pierre said his organization is often unfairly looked at as the boogeyman by the industry, when in fact FDA is only a "first step" in the process of getting a product to market. "The products still have to demonstrate their use in the clinical practice and if they do, hopefully they'll get reimbursed better."

When asked by Duval about a staff member's response to getting outranked in a decision process, via a company seeking an opinion from someone higher up the chain of command, St. Pierre said that staff are trained to expect that and not to deal with it in a petty vengeful way. Where problems can occur, he said, is when a staff member feels that a company is telling a different story to his or her superior to what they were told by the same group.

The best time to make that decision to talk to a superior, he said is during the review process "because you can impact" the decisions as far a product is concerned much more effectively. "If you're going to go up the line, just be transparent and honest. Don't go behind the back" of the staff.

St. Pierre that contrary to what some people might think, the agency does not take delight in issuing Not Substantially Equivalent (NSE) letters on proposed 501(k)s. "An NSE decision is just a total waste of time," he said. "All the energy put in by the company and by the FDA staff. When you get to an NSE, nobody benefits at all."

He said that there is only a 3% to 5% NSE issuance rate at the agency, and some companies are able to go the de novo route. A De Novo provides a possible route to market low risk device types. The de novo process is intended to apply to low-risk products that have been classified as class III because they were found NSE to any identifiable predicate device. An applicant of a 510(k) who receives a NSE determination placing the device into a Class III category can request a de novo classification of the product into Class I or II

On the issue of the least-burdensome pathway of the FDA Modernization Act of 1997 (FDAMA), St. Pierre said that he's had companies come in with no data and say that's least burdensome. "You're right, he joked, "You got me there."

He said that this really means providing a reasonable least burdensome approach that gets good products to market as quickly as possible. He said that he's sorry if a clinical trial costs to much when it's warranted to get a device to market, but that doesn't fit into the least burdensome mandate either.

While St. Pierre said that 510(k)s are getting harder to expedite, he blamed that more on the complexity of the devices than anything else. He also noted that because the devices have become more complex in nature, they require more than one reviewer to work on a product, which he said never happened in the 1990s. "So are getting a broader perspective on 510(k)s. There's a perception that the evidence creep is increasing and I think it is and I'm not sure if that's a bad thing, it kind of preserves the program."

St. Pierre said he doesn't buy the argument that because something requires a PMA that it shouldn't be funded by venture capitalists. "I don't know what to do about that," he said.

He said that if one wants the FDA to look favorably on their product "don't talk about how much it's going to cost you to study or how burdensome the study is, come in start your conversation with 'this product is going to add this to patient care, this is how the patient is going to be impacted.'"

St. Pierre said that if the staff comes in and sees what you are saying about the significance of a product "then they are going to work with you to see that happens and that product comes to fruition."