This morning attendees at OrthoTec 2012 received an insider perspective on recent agency developments, changes to FDA staff training, and developments related to the 510(k) program and the benefit-risk guidance, among other updates.
Stephanie Bechtold, scientific reviewer in the Orthopedic Spine Devices Branch in the Office of Device Evaluation at CDRH opened the conference and took some questions from the audience.
Q: Regarding PMA and 510(k) submissions, are there specific areas in which you see more issues than others in terms of communication?
Bechtold: From a reviewer perspective, the PMA timeframe of the Tier I goal of 180 days is a challenge to try to meet, especially in light of panel meetings that are often necessary. In those cases, the interactive review is key in the initial stages of the PMA, because that can help us narrow down what the key issues are that might need to go out in a letter in the future. The interactive review can really help with the initial clarifications—things that we just need to know off the bat that we can get over and then really get into the meat of the discussion.
Q: In the 510(k) guidance, you mentioned about the verified 510 (k) summary info. What type of verification is necessary for that?
Bechtold: It’s a continuation of the policies that have been enacted informally for the last couple of months. The 510(k) summary just became a public document, so we need to make sure that the information in there is correct as far as what predicates are being cited, and what preclinical or other testing or performance data was needed to make that decision. We’ve been doing that a bit more informally over the last few months, but this is just a formalization of that process.
Q: What’s your perspective on the dynamic between orthopaedic manufacturers and FDA, and reviewers? What are the challenges?
As a lead reviewer, I’m not seeing interaction with some of the other organizations. We have a constant presence at the OSMA [Orthopedic Surgical Manufacturers Association] meeting and the orthopaedic device forum meetings. We’re trying to keep an open line of communication with all representatives in the orthopaedic industry. We try to go out, and through programs such as the Experiential Learning Program
, we’re going out and seeing some of the manufacturing sites and the sites firsthand to open that line of communication with the people who we’re working with every day.
Q: What other products are planned for the Innovation Pathway? Do you foresee any orthopaedic products entering the program in the future?
Bechtold: I see a lot of potential for orthopaedics to be involved in that program. It’s in the pilot stage—it’s just getting off the ground with the end-stage renal disease product area. As soon as those get mre off the ground and we can see how everything is working, we can discuss other product areas, but we’re not at that stage yet.
Q: At last week’s MDMA annual meeting, Jeff Shuren mention that he sees the Innovation Pathway changing the landscape of how FDA does business. What are your thoughts on the program?
Bechtold: I think it could really have an effect on some of the novel products that are coming out in the orthopaedic area. I think sometimes the regulatory hurdles can be a little difficult for small companies. Something like the Innovation Pathway could be a potential for some of those pathways to be opened for brand new products.
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