Cautiously optimistic was the word from LifeScience Alley after the FDA released details Wednesday on current and future plans for changes to the 510(k) medical device approval process.
“They’re moving in a positive direction,” said Dale Wahlstrom, the CEO of the Minneapolis-based nonprofit trade association, said. “I was surprised to see 25 things they’re doing right now to make it better, with really tight timelines. That to me says they want to show success quickly, and that’s good as long as they implement with an appropriate amount of detail that doesn’t catch us by surprise.”
The detail, of course, is the catch.
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“The area of concern is the significant number of items that they delayed decision on as they move into dialog with [The Institute of Medicine].”
This summer, The Institute of Medicine is expected to advise the FDA on the most controversial proposals for industry, such as:
- Defining the FDA’s authority to rescind devices that have previously received clearance
- Clarifying when a previously cleared device can no longer be used as a “predicate”
- Establishing a new class of devices, called “IIb,” that would require clinical data submissions
“The nature of many of those items are operationally based,” Wahlstrom said. “For companies their implications will have a day-to-day impact.”
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Ryan Baird, communications manager for LifeScience Alley, noted that the IOM committee has no industry representatives. That lack of input in what will be a private process is worrisome, Baird said.
Wahlstrom added: “Anything coming out of the IOM will have an impact on the regulatory process trajectory. Yes, you have an opportunity for public input, but the further down the stream the FDA had moved in its decision-making process, the less chance you have of influencing the outcome. Whether that’s a problem or not, nobody knows.”
LifeScience Alley also on Wednesday issued a formal reaction on its web site.
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