Non-Invasive Blood Pressure (NIBP) Monitor Guidance

Description

This document is intended to provide guidance in the preparation of a regulatory submission.It does not bind the FDA or the regulated industry in any manner.

Scope & Applicability

• 21CFR814.20§ 814.20 Application.

  (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Investigational Review Board (IRB)

  Nobles Medical Technology II, Inc.

  2024-03-12

• CGMP/QSR/Medical Devices/Adulterated

  Synovo Production, Inc.

  2023-04-04

• Investigational Device Exemptions (Clinical Investigator)

  Kennedy, Philip R.

  2020-04-07

• Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
• CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
• Color Additive Petitions - Medical Devices (Status: Final)
• Shelf Life of Medical Devices (Status: Final)
• Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 : Guidance for Industry (Status: Final)
• Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (Status: Final)
• Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)