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Executive Summary

The Center for Devices and Radiological Health is shaking up how its pre- and post-market specialists interact under a new "Total Product Life Cycle" scheme.

Life Cycle - Text on Conceptual Gauge with Red Needle. 3D.


A shakeup is on the horizon for how pre- and post-market experts at US FDA's device center interact under a new "Total Product Life Cycle" initiative. The scheme aims to provide the agency with better visibility of products, device-makers and various device classes from cradle-to-grave to help guide its pre- and post-approval decision-making.

"One of the things we’re doing inside the agency, inside CDRH specifically, is looking at how we work together. Not only are we trying to figure out how we can collaborate better across offices at the center, but we’re literally talking about how do we blend pre-market and post-market specialists into the same team," said Robin Newman, director of the Office of Compliance within FDA's Center for Devices and Radiological Health.

"This is going to be, I think, a very powerful learning tool for all of us," CDRH compliance head Robin Newman says.

With pre- and post-market teams working together, the agency can respond more quickly to critical safety issues because it will have immediate access to expanded array of data streams.

"This is ultimately going to result in a very significant reorganization in the future, but at this point in time we’re still doing the modeling, trying to figure out what kind of organization does this most effectively," Newman said at FDAnews' 14th Annual Medical Device Quality Congress in Bethesda, Md.

"It’s like the old saying: 'If only the company knew what the company knows.' Well, now it's, 'If only the agency knew what the agency knows,'" she said. The TPLC initiative "is a way to help ensure that we do know about these [critical] things."

There are nine overarching goals for the TPLC scheme. The first is to gain a "big-picture, holistic look across the lifecycle of a product so pre-market decisions can be informed by post-market experiences or post-approval experiences," Newman said.


TPLC Goals

  • Promote a focus on “big-picture,” holistic, patient-centered decision-making
  • Promote increased responsibility and accountability for urgent safety issues
  • Leverage knowledge from post-market and compliance programs to make better informed pre-market decisions, and vice versa
  • Increase FDA knowledge about specific devices
  • Increase staff access to and integration of Total Product Life Cycle information about the medical devices for which they are responsible
  • Minimize delays in information-sharing
  • Ensure process consistency
  • Facilitate policy consistency
  • Support timely review of all products


The agency is also looking to educate itself more on particular products. "This way, the post-market group, or the Office of Compliance's current teams, are being informed by the people who are really living in the science, and in OSB and ODE," Newman said. "This is going to be, I think, a very powerful learning tool for all of us."

OSB is FDA's Office of Surveillance and Biometrics, and ODE is the agency's Office of Device Evaluation.

FDA already has a publicly searchable TPLC database that includes pre- and post-market data about devices. It pulls information from various CDRH databases on PMAs, 510(k)s, adverse events and product recalls.

"But now, the real work starts. We have to design the re-org of the organization," Newman said. "Fortunately, we’re not going to have to do it in isolation. We’re going to get a little help from some specialists who understand this better than we do, but the bottom line is, we’re not standing still. We’re already in very rigorous discussion around some pilot programs that we can put together that encourage this information-sharing and this broad reach across the agency."

She admitted that the TPLC process is somewhat "scary" and "challenging." However, "I really believe … this will serve patients better than almost anything we can do, if we really are able to truly exploit the knowledge that we already currently have across the entire center."

From the editors of The Gray Sheet

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