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Notice. "Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability" Federal Register 74, no. 176 (September 14, 2009): 46996. https://www.govinfo.gov/app/details/FR-2009-09-14/E9-22019.
Office of the Federal Register, National Archives and Records Administration. (). 74 FR 46996 - Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability. [Government]. Office of the Federal Register, National Archives and Records Administration. https://www.govinfo.gov/app/details/FR-2009-09-14/E9-22019
Office of the Federal Register, National Archives and Records Administration. 74 FR 46996 - Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability. Office of the Federal Register, National Archives and Records Administration, , https://www.govinfo.gov/app/details/FR-2009-09-14/E9-22019
Office of the Federal Register, National Archives and Records Administration, Draft Guidance for Industry and Food and Drug Administration Staff; Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Availability, govinfo, (September 14, 2009), https://www.govinfo.gov/app/details/FR-2009-09-14/E9-22019.
Close xFederal Register Volume 74, Issue 176 (September 14, 2009)
Regulatory Information
Federal Register
AE 2.7:
GS 4.107:
AE 2.106:
Office of the Federal Register, National Archives and Records Administration
Notices
Notice.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 14, 2009.
Elias Mallis, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1312, Silver Spring, MD 20993, 301-796-6216.
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation." This draft guidance provides FDA's proposed recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation. This draft guidance is not final nor is it in effect at this time.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
46996-46996
74 FR 46996
Docket No. FDA-2009-D-0395
E9-22019