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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting: Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health - February 9, 2010


Federal Register Notice

FDA has published a notice in the Federal Register announcing a public meeting on February 9, 2010, and requesting comments on a number of questions regarding how CDRH should anticipate and respond to new or evolving scientific knowledge in a manner that is consistent with our mission to protect and promote the public health.

Please see Docket No. FDA-2009-N-0575. Incorporation of New Science Into Regulatory Decisionmaking Within the Center for Devices and Radiological Health; Public Workshop, Request for Comments.

Comments are due February 24, 2010.

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Date, Time, and Location

The meeting will be held on February 9, 2010, from 8:00 a.m. to 5:00 p.m. at the following location:

Hilton Washington DC North/Gaithersburg
620 Perry Pkwy.
Gaithersburg, MD 20877
301-977-8900

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Registration

NOTE: Registration for this meeting has closed. The meeting has filled to capacity, and there is a waiting list. We will not be able to accommodate same-day registrations on the morning of February 9.

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Additional Information

 

I. Tentative Agenda 

8:00-8:05 Welcome and Opening Remarks
Jeffrey Shuren, MD, JD, Center Director, CDRH
8:05-8:15 Overview: Structure of the Day and Logistics
Jonathan Sackner-Bernstein, MD, Associate Director for Postmarket Operations, CDRH
8:15-8:30 Discussion Group Introductions
FDA and Invited Discussants
8:30-9:45 Moderated Discussion 1 – Case Study 1
FDA and Invited Discussants
9:45-10:00 Break
10:00-11:00 Moderated Discussion 2 – Case Study 2
FDA and Invited Discussants
11:00-12:00 Open Public Session 1 – Case Studies 1 & 2
Registered Participants
12:00-1:30 Lunch (on own)
1:30-2:45 Moderated Discussion 3 – Case Study 3
FDA and Invited Discussants
2:45-3:00 Break
3:00-4:00 Moderated Discussion 4 – Case Study 4
FDA and Invited Discussants
4:00-4:55 Open Public Session 2 – Case Studies 3 & 4
Registered Participants
4:55-5:00 Closing Remarks
Jeffrey Shuren, MD, JD, Center Director, CDRH

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II. Case Studies for Discussion 

The case studies below will serve as a jumping-off point for discussion and comment during the public meeting. Relevant questions from the Federal Register Notice are indicated below as Questions of Interest. The letter and number preceding each question correspond to the letter and number used to label that question in the Federal Register Notice.

Case Study 1: Postmarket Information
  • Scenario A: CDRH clears Device X for marketing through the 510(k) process. Device X is cleared for a specific intended use. Several years later, a pattern of Medical Device Reports (MDRs) that have been submitted to CDRH calls into question the safety of the device when used in the long term for its cleared use. A number of other devices of the same type and with the same intended use as Device X are on the market when this new safety information comes to light. There is also a device of the same type, Device Y, under review through the 510(k) process. The 510(k) submission for Device Y cites Device X as a predicate.
  • Scenario B: CDRH approves Device Z for marketing through the PMA process on the basis of favorable results in a pivotal clinical trial. Several years later, a compelling peer-reviewed publication reports that an attempt to replicate these clinical trial results was unsuccessful. A number of other devices of the same type and with the same intended use as Device Z are PMA-approved and on the market when this article comes to light. There is also a device of the same type and for the same intended use, Device Q, under review through the PMA process.
Questions of Interest:
  • (A)(1) When CDRH gains new scientific information about a particular product or type of product, what should the criteria be for changing CDRH’s expectations of the evidence necessary for pre- or postmarket regulatory decisions, keeping in mind our mission to protect and promote the public health, as well as our statutory and regulatory framework?
  • (A)(3) When such changes are warranted, how should CDRH apply them to devices currently under review?
  • (A)(4) When such changes are warranted, how should CDRH apply them to products currently on the market?

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Case Study 2: Changes in Clinical Science

A company works with CDRH to design a three-year clinical trial to study an investigational device, Device J. The trial will assess the effect of Device J on a particular measurable variable, which is meant to be a surrogate for a specific clinical outcome. In year two of the trial, CDRH learns from other compelling peer-reviewed studies in publication that the surrogate does not reliably track the expected clinical outcome.

Consider the following variations on the case above:

  • Scenario A: Prior to this point, CDRH has not cleared or approved any other devices on the basis of clinical trials using this surrogate endpoint.
  • Scenario B: Prior to this point, CDRH has cleared or approved a number of other devices on the basis of clinical trials using this surrogate endpoint.
  • Scenario C: At this point, there are several other investigational devices that are being tested in clinical trials using this surrogate endpoint.
  • Scenario D: At this point, CDRH is reviewing a PMA for an investigational device that was tested in a clinical trial using this surrogate endpoint.
Questions of Interest:
  • (A)(1) When CDRH gains new scientific information about a particular product or type of product, what should the criteria be for changing CDRH’s expectations of the evidence necessary for pre- or postmarket regulatory decisions, keeping in mind our mission to protect and promote the public health, as well as our statutory and regulatory framework?
  • (A)(2) When such changes are warranted, how should the Center communicate them to industry, consumers, and other external constituencies? Should CDRH have a new regulatory paradigm for communicating with outside parties?
  • (A)(3) When such changes are warranted, how should CDRH apply them to devices currently under review?

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Case Study 3: Technological Improvements

CDRH clears Device W through the 510(k) process. At the time of clearance, it is considered to be state of the art. A number of other devices of the same type and with the same intended use as Device W soon come onto the market. Over the following years, devices of the same type and for the same intended use evolve through several generations, leading to a new state of the art device with a significantly more favorable risk-benefit profile than that of Device W and similar older devices. Device W and similar older devices are still in market use. There is also a device of the same type, Device R, under review through the 510(k) process. Device R has a similar risk-benefit profile to that of Device W, and the 510(k) submission for Device R cites Device W as a predicate.

For the purposes of discussion, assume that all of the later-generation devices use Device W as their predicate.

Consider the following variations on the case above:

  • Scenario A: The newest devices are shown to be safer than Device W and similar older devices, but seem to have roughly the same level of effectiveness.
  • Scenario B: The newest devices are shown to be more effective than Device W and similar older devices for their intended use, but seem to have roughly the same level of safety.
  • Scenario C: The newest devices are shown to be both safer and more effective than Device W and similar older devices.
Questions of Interest:
  • (A)(1) When CDRH gains new scientific information about a particular product or type of product, what should the criteria be for changing CDRH’s expectations of the evidence necessary for pre- or postmarket regulatory decisions, keeping in mind our mission to protect and promote the public health, as well as our statutory and regulatory framework?
  • (A)(3) When such changes are warranted, how should CDRH apply them to devices currently under review?
  • (A)(4) When such changes are warranted, how should CDRH apply them to products currently on the market? For example, how should CDRH treat “first-generation” products as new and improved versions are developed?

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Case Study 4: Novel Technology

A device currently under review within CDRH is a first of a kind device that uses a new material with unique or unknown biocompatibility properties..

Questions of Interest:
  • (B)(1) Assessing the safety and effectiveness of a novel technology can be challenging because the extent of information on and the level of understanding of the technology's risk-benefit profile or manufacturing process is less mature than that of a technology for which there is extensive “real-world” experience. What steps should CDRH take to assure that novel technologies or novel uses of existing technologies are safe and effective, without creating barriers to innovation, keeping in mind our statutory and regulatory framework?
  • (C)(1) With current resources, what proactive steps should CDRH take to address gaps in staff-members' knowledge about new science and reduce uncertainty in science-based regulatory decision making?

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III. Invited Discussants 

  • Jon Cammack, Ph.D., D.A.B.T., President and CEO, ISIS Services
  • Vivian Coates, MBA, Vice President, Information Services and Health Technology Assessment, ECRI Institute
  • Steven Curley, MD,  Professor of Surgery, Chief of Gastrointestinal Tumor Surgery, and Program Director of Multidisciplinary Gastrointestinal Cancer Care at the University of Texas M. D. Anderson Cancer Center
  • Hanson Gifford, Partner, The Foundry, LLC. Representing the Medical Device Manufacturers Association (MDMA)
  • Steven Nissen, MD, Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic
  • Sharon-Lise Normand, PhD, Professor of Health Care Policy in the Department of health Care Policy at Harvard Medical School and in the Department of Biostatistics at the Harvard School of Public Health
  • Patricia Schrader, JD, Senior Vice President, Corporate Regulatory and External Affairs, Becton, Dickinson, and Company. Representing the Advanced Medical Technology Association (AdvaMed)
  • Joe Smith, MD, PhD, Vice President, Emerging Technologies, Corporate Office of Science & Technology, Johnson & Johnson
  • Rear Admiral John Villforth, Former Assistant Surgeon General and Chief Engineer of the U.S. Public Health Service, and Former Director of CDRH (1982-1990)
  • Timothy Wright, PhD, Principal Scientist, Biomechanics and Biomaterials Lab, Hospital for Special Surgery
  • Diana Zuckerman, PhD, President, National Research Center for Women & Families

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IV. Transcript 

Due to inclement weather, FDA established a conference call-in option for audience members who could not attend this meeting. A full recording of the conference call is provided below. The recording captures the meeting in full.

A verbatim transcript will be provided on this website as soon as possible.

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Contacts

For further information about this meeting, contact:

Maggie Dietrich
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Building 66, Room 5449
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-5094
e-mail: maggie.dietrich@fda.hhs.gov

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