The Food and Drug Administration (FDA) is announcing a public workshop entitled, “Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures; Public Workshop”. The purpose of the public workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders to f urther refine and advance the IDEAL initiative (Idea Development Exploration, Assessment and Long-Term Study) and TPLC (Total Product Life Cycle) frameworks related to evidence generation and evaluation for surgical devices and procedures.

• Date, Time and Location
• Federal Register Notice
• Agenda
• Related Information
• Registration
• Contact Us

This meeting will be held on December 2, 2011, beginning at 8:00 a.m. – 5:30 p.m., at the following location:

FDA White Oak Campus

10903 New Hampshire Avenue

Building 31 Conference Center (Great Room, Room 1503)

Silver Spring, MD 20993

The meeting will be webcasted.

Available soon.

• Blazeby J, Blencowe N, Titcomb D, Metcalfe C, Hollowood A, and Barham C (2011).

  Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy.

  British Journal of Surgery, 98:544-551.

• Barkun J, Aronson J, Feldman L, Maddern G, and Strasberg S (2009).

  Surgical Innovation and Evaluation 1: Evaluation and stages of surgical innovations.

  The Lancet, 374:1089-96.

• Ergina P, Cook J, Blazeby J, Boutron I, Clavien P, Reeves B, and Seiler C (2009).

  Surgical Innovation and Evaluation 2: Challenges in evaluating surgical innovation.

  The Lancet, 374:1097-104.

• McCulloch P, Altman D, Campbell B, Flum D, Glasziou P, and Marshall J (2009).

  Surgical Innovation and Evaluation 3: No surgical innovation without evaluation: the IDEAL recommendations.

  The Lancet, 374:1105-12.

If you wish to attend this Workshop or participate via webcast, you must register by 5:00 p.m. on November 25, 2011.

There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you need special accommodations due to a disability, or additional information regarding registration, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

For information regarding the program, contact:

Samantha Jacobs,

Food and Drug Administration, Center for Devices and Radiological Health

10903 New Hampshire Ave., Bldg. 66 Rm. 4113

Silver Spring, MD 20993

(301) 796- 6897

Email: Samantha.jacobs@fda.hhs.gov;

OR

Danica Marinac-Dabic, MD, PhD

Food and Drug Administration, Center for Devices and Radiological Health

10903 New Hampshire Ave. , Bldg. 66, Rm. 4113

Silver Spring, MD 20993

(301) 796 - 6689

Email: danica.marinac-dabic@fda.hhs.gov.

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