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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 17-1
Standard
AAMI  NS28:1988/(R) 2015
Intracranial pressure monitoring devices
Scope/Abstract
This standard establishes minimum labeling, safety, and performance requirements for intracranial pressure monitoring devices, whether percutaneous, fully implantable, or noninvasive. Also covered by this standard are test and calibration methods needed to establish compliance with the standard. The following components, which individually or in combination comprise ICP monitor assemblies, are within the scope of this standard when supplied by the manufacturer of the ICP monitoring device: (1) Percutaneous fluid-coupled devices, such as ventricular catheters, skull-fixated subarachnoid and subdural devices, subdural balloons and subdural catheters, and connecting tubing for percutaneous fluid-coupled devices; (2) Patient/device interfaces for remote-sensor, servomechanism-regulated devices, such as percutaneous optical, pneumatic, or electrical leads; remote transducers; internal pneumatic devices; and display modules; (3) Implantable electrical transducers with percutaneous leads (strain gauges), such as implantable, diaphragm-mounted, strain-gauge transducers and implantable, passive-resistance, circuit transducers (variable inductance and capacitance); and (4) Fully implantable devices, such as variable oscillators, passive-absorption devices, and interrogators, receivers, display modules, power sources, and pressure-balancing devices for the transducers in (3).
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 3.2.11 Biocompatibility
Rationale for Recognition
This standard is relevant to medical devices and is recognized because it may be used in support of scientific and regulatory decision making.

This standard is recognized in part because:

Clause 3.2.11 Biocompatibility is in conflict with existing published final guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff, Issued June 2016.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.1620 Device, Monitoring, Intracranial Pressure Class 2 GWM
Relevant FDA Guidance and/or Supportive Publications*
AAMI / ANSI / ISO 10993-6:2007/(R)2014, Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects after Implantation.
AAMI / ANSI ST72:2011/(R)2016, Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing.
AAMI/ANSI/ISO 10993-10: 2010(R)2014, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization
AAMI/ANSI/ISO 10993-11:2006/(R)2010 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity
AAMI/ANSI/ISO 10993-3:2003/(R)2009 Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
AAMI/ANSI/ISO 10993-7:2008/(R)2012, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Document issued on: May 11, 2005
Guidance for Industry: Pyrogens and Endotoxins Testing: Questions and Answers, Issued June 2012.
Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff, Issued June 2016.
USP 40-NF35:2017, <85> Bacterial Endotoxins Test
USP 39-NF34:2016, <151> Pyrogen Test

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Xiaorui Tang
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6500
  Xiaorui.Tang@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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