FDA Recognizes 138 Consensus Standards


Posted January 29, 2019

The Food and Drug Administration (FDA) has added 138 consensus standards to its online recognition database, including 23 developed by AAMI or AAMI-managed committees. By achieving FDA recognition, these voluntary consensus standards can now be used in premarket submissions to demonstrate conformity with pertinent FDA regulations and requirements. 

“AAMI’s mission is to promote safety and efficacy in medical devices. For our work to have a positive impact, the standards must be utilized by clinicians and manufacturers,” said Joe Lewelling, AAMI’s vice president of emerging technologies and health IT standards. “Official recognition by regulatory authorities such as the FDA helps promote that use and helps ensure that safety and efficacy are being addressed.”

Based on final guidance published in September 2018, the FDA now indicates when a standard is targeted for recognition in its online database once that decision is made. The newly listed standards then can be used immediately by medical device manufacturers to support their premarket submissions rather than waiting for publication in the Federal Register.

“[The] Center for Devices and Radiological Health encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their submissions, as conformity to relevant standards streamlines regulatory review and fosters quality,” the FDA wrote on its website. “Standards are particularly useful when an FDA-recognized consensus standard exists that serves as a complete performance standard for a specific medical device.”

The following AAMI standards were among those recognized by the FDA:

  • ANSI/AAMI ST55:2016, Table-top steam sterilizers
  • ANSI/AAMI NS4:2013/(R)2017, Transcutaneous electrical nerve stimulators
  • ANSI/AAMI ST77:2013/(R)2018, Containment devices for reusable medical device sterilization
  • ANSI/AAMI ST67:2011/(R)2017, Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled ‘sterile’
  • ANSI/AAMI SW91:2018, Classification of defects in health software
  • ANSI/AAMI BP22:1994/(R)2016, Blood pressure transducers
  • ANSI/AAMI EC12:2000/(R)2015, Disposable ECG electrodes
  • ANSI/AAMI/IEC 60601-2-47:2012/(R)2016, Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
  • ANSI/AAMI/IEC 62304:2006, Medical device software – Software life cycle processes
  • ANSI/AAMI/ISO 25539-1:2017, Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses

AAMI manages the international development of the following standards, which also received FDA recognition:

  • IEC 80601-2-30:2018, Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
  • ISO 22442-3:2007, Medical devices utilizing animal tissues and their derivatives – Part 3:  Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
  • ISO 18835:2015, Inhalational anaesthesia systems – Draw-over anaesthetic systems
  • ISO 5366:2016, Anaesthetic and respiratory equipment – Tracheostomy tubes and connectors
  • ISO 18190:2016, Anaesthetic and respiratory equipment – General requirements for airways and related equipment
  • ISO 81060-2:2013, Non-invasive sphygmomanometers – Part 2: Clinical validation of automated measurement type
  • SO/TS 17137:2014, Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants
  • ISO 5910:2018, Cardiovascular implants and extracorporeal systems – Cardiac valve repair devices
  • ISO 80601-2-13:2011, Medical electrical equipment – Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (including amendment 1 [2015] and amendment 2 [2018])
  • ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
  • ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements
  • IEC 60601-2-27:2011, Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (including corrigendum 1 [2012])
  • IEC 60601-2-16 (2018), Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration, and haemofiltration equipment
  • IEC 62304, Medical device software – Software life cycle processes (consolidated version)