Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

047

Date of Entry 08/21/2017

FR Recognition Number

4-239

Standard

ANSI AAMI CI86:2017
Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting

Scope/Abstract

This standard establishes minimum requirements for those active implantable medical devices known as cochlear implants or cochlear prostheses, which are intended to treat hearing impairment by means of electrical stimulation of the cochlea. Devices that treat hearing impairment other than by including electrical stimulation of the cochlea are not covered by this standard. This standard applies to the electrical stimulation component(s) of combination devices that treat hearing impairment using multiple means, including electrical stimulation. The tests specified in this standard are industry-accepted tests and are to be carried out on samples of devices to show compliance. This standard is also applicable to non-implantable parts and accessories of the devices, including fitting and diagnostic components. General and specific requirements are provided with regard to design verification, post-implantation device testing, reliability assessment and reporting, packaging and labeling, protections of the patient associated with design issues and device malfunctions, and protections of the device associated with environmental challenges arising from transport, storage, handling during implantation, unrelated medical treatments, and normal use.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
N/A	Implant, Cochlear	Class 3	MCM
N/A	Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification	Class 3	PGQ

Relevant FDA Guidance and/or Supportive Publications*

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 Contacts

Vasant Dasika

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-5365

Vasant.Dasika@fda.hhs.gov

Srinivas Nandkumar

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6480

srinivas.nandkumar@fda.hhs.gov

Standards Development Organizations