510(k) Sponsors Should Be Wary Of Informal Talk With FDA, Attorney Says

Full article reprinted from "The Gray Sheet" - August 3, 2009

Informal communications via telephone or e-mail before or during a 510(k) submission can be an efficient approach for sponsors, but companies should be aware of the pitfalls, says Hogan & Hartson Partner and FDA device specialist John Smith. Read more...

510(k) Sponsors Should Be Wary Of Informal Talk With FDA, Attorney Says

Full article reprinted from "The Gray Sheet" - August 3, 2009

Informal communications via telephone or e-mail before or during a 510(k) submission can be an efficient approach for sponsors, but companies should be aware of the pitfalls, says Hogan & Hartson Partner and FDA device specialist John Smith.

Informal communications are "completely non-binding on the agency," Smith said during a July 22 Web conference. "They can tell you something you like, you can base your response or even a submission on them, and this can really come back to haunt you. I can't tell how many times we've seen this occur."

In some cases, FDA feedback during informal communications can be "entirely wrong," Smith contends, because the agency either does not fully understand what a company is "getting at" or because the individual reviewer with whom the company spoke is not in agreement with the whole review team's take on the situation.

Misunderstandings about a device can also arise from informal communications. This "can start a misimpression that can be very difficult to manage," Smith said.

In other cases, depending on how much information a company supplies FDA during an informal communication, the agency can decide that the firm has, in fact, submitted a "pre-IDE" instead, which requires the sponsor to stick with more specific time frames, he warned.

The best time to use informal communications with FDA is if a company has a "simple, straightforward question with a clear go-to individual at FDA," Smith said. "For instance there are certain people at FDA who are known laser experts. If you've got a relationship with them, talk to them. If it's a straightforward question, it's probably a good reality check."

A company that is in the middle of a review can also informally approach its reviewer, he said. This process has become somewhat more routine with last year's formal advent of an "interactive" review process (The Gray Sheet Jan. 7, 2008.)

If there is any chance FDA can misunderstand the communication, Smith recommended that companies provide background to the agency in writing so that it can see what the questions are and what the company's position is.

- Ingrid Mezo

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