Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

Description

For questions regarding this document, contact the Cardiac Electrophysiology Devices Branch at 301-796-5631.

Scope & Applicability

Regulatory Context

• 21CFR878.4350§ 878.4350 Cryosurgical unit and accessories.

  (a) Identification —Read full regulation →

• 21CFR812.25§ 812.25 Investigational plan.

  The investigational plan shall include, in the following order:Read full regulation →

• 21CFR812.43§ 812.43 Selecting investigators and monitors.

  (a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.Read full regulation →

• 21CFR814.82§ 814.82 Postapproval requirements.

  (a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →

• 21CFR878.4400§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

  (a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.Read full regulation →

• 21CFR878.4810§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

  (a) Identification.Read full regulation →

• 21CFR812.3§ 812.3 Definitions.

  (a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →

• 21CFR812.42§ 812.42 FDA and IRB approval.

  A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.Read full regulation →

• 21CFR860.7§ 860.7 Determination of safety and effectiveness.

  (a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →

• 21CFR812.30§ 812.30 FDA action on applications.

  (a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:Read full regulation →

• 21CFR812.46§ 812.46 Monitoring investigations.

  (a) Securing compliance. A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable FDA regulations, or any conditions of approval imposed by the reviewing IRB or FDA shall promptly either securRead full regulation →

• 21CFR812.40§ 812.40 General responsibilities of sponsors.

  Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensurRead full regulation →

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Clinical Investigator

  Americo F. Padilla, M.D.

  2025-03-25

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Clinical Investigator (Sponsor)

  Angela D. Ritter, M.D.

  2024-06-18

• Institutional Review Board (IRB)

  New York State Psychiatric Institute IRB

  2024-03-26

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