The Medtronic Micra is an example of some of the new leadless pacemaker technologies in development that are expected to soon be reviewed by the FDA as they move toward U.S. commercialization.
December 31, 2015 — The U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet in February to discuss and gather public recommendations on clinical trial, post-approval study design and physician training requirements for leadless cardiac pacemaker device technology. The meeting will take place Thursday, Feb. 18, 2016, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD, 20877. The hotel telephone number is 301-977-8900.
The committee will be asked to make recommendations on the acceptability of adverse event rates in acute and chronic timeframes as well as indications for use for this device type, given availability of other technologies with different adverse event profiles; required training and acceptability of observed learning curves for the new device type and necessary elements for post-approval study collection.
FDA intends to make background material available to the public no later than two business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee meeting link.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before Feb.11, 2016. Oral presentations from the public will be scheduled between approximately 1 and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before Feb. 3, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by Feb. 4, 2016.
