Phoenix Ambulatory Blood Pressure Monitor Project
Sub-project: Regulatory Approval - Requirements

 

Description

This section describes the regulatory approval requirements and highlights the requirements that apply to Phoenix. It is likely that the Phoenix monitor will be classified as a Class II device.

Topics

• Overview - Getting To Market With A Medical Device
• Obtain Marketing Clearance from Center for Devices and Radiological Health (CDRH)
  • Determine that the device meets the Definition of a Medical Device
    • General Controls for Medical Devices
    • If the device emits radiation - Electronic Product Radiation Control
  • Determine how the product is likely to be classified to determine the required marketing process, either
    • Premarket Notification [510(k)] for Class I, II and some III devices - the regulation
      • Guidance for non-invasive blood pressure monitors
      • Guidance for Non-Automated Sphygmomanometer (Blood Pressure Cuff)
    • Premarket Approval (PMA) for Class III devices - the regulation
    • Exempted Devices
      • Most Class I devices and a few Class II devices are exempt from the premarket notification [510(k)] requirements - Class I exemption regulation and Class II exemption regulation
  • Develop data and information to submit a marketing application and to obtain clearance to market
    • Determine if clinical performance data is required
      • Required for some [510(k)] submissions and most PMA applications
      • Investigational Trial for Exempted Devices
  • Submit the marketing application and support CDRH's review process
• Premarket Requirements: Labeling, Registration, Listing
  • Labeling Regulations
  • Submitting FDA Form 2891 and 2892 accomplishes the:
    • Registration regulation
    • Listing regulation
• Postmarket Requirements: Quality System, Medical Device Reporting
  • Quality System (QS) Regulation Overview and the QS Regulation (21 CFR H-Medical Devices Part 820)
  • Medical Device Reporting (MDR) Regulation Overview and the MDR Regulation
• Other
  • Electronic Records; Electronic Signatures, 21 CFR Part 11
  • 21 CFR - All
  • General Principles of Software Validation

 

Other regulations include

• Nonautomated Sphygmomanometers (ANSI/AAMI SP9­1994) Establishes labeling requirements, performance requirements, test methods, and referee test methods for nonautomated sphygmomanometers used in the indirect measurement of blood pressure. Requirements are listed for the manometer, inflation source and pressure control valve, inflatable bladder and cuff, and system leakage.
• Electronic or Automated Sphygmomanometers (ANSI/AAMI SP10­1992) Covers labeling requirements, safety and performance requirements, and referee test methods for electronic or automated sphygmomanometers used in indirect blood pressure measurement. Specific requirements for ambulatory blood pressure monitors are included.

 

 

About This Page

This page is maintained by Ellis S. Nolley. It was last updated on 01 March 2005.

The author(s) provide this information as a public service, and agree to place any novel and useful inventions disclosed herein into the public domain. They are not aware that this material infringes on the patent, copyright, trademark or trade secret rights of others. However, there is a possibility that such infringement may exist without their knowledge. The user assumes all responsibility for determining if this information infringes on the intellectual property rights of others before applying it to products or services.

Copyright (C) 2005 Ellis S. Nolley. Copying and distribution of this page is permitted in any medium, provided this notice is preserved.

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