The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. The document is intended to provide additional clarifications and recommendations to be considered by the industry representatives, accreditation bodies, and testing laboratories. The guidance constitutes a final version of the document published earlier in September 2019.

Regulatory Background

The present FDA guidance covers the aspects associated with the basic safety and essential performance standards applicable in the context of the ASCA Pilot. The document provides the following:

  • The information on the consensus standards recognized by the FDA and allowed to be used to demonstrate basic safety and essential performance in the context of the ASCA Pilot,
  • The program specifications for the aforementioned standards,
  • Certain recommendations on the content of the premarket submission to be filed in cases when an ASCA-accredited testing laboratory carries out testing of a medical device or equipment in question. 

At the same time, the detailed information on the ASCA Pilot itself is provided in a special guidance document dedicated to the Pilot Program itself.

FDA-Recognized Consensus Standards for Medical Electrical Equipment 

As it was mentioned above, in the present FDA guidance, the Agency provides a list of consensus standards to be applied when placing medical equipment on the market under the ASCA Pilot framework. The Agency additionally emphasizes the importance of the safety-related aspects for electrically powered medical devices. According to the document, the most commonly used standards are:

  • IEC 60601/80601 series – for the devices intended to be used in the clinical environment, and
  • IEC 61010-1 series – for the device used in the laboratory environment. 

The Agency states that the aforementioned standards actually employ a general approach to all safety-related aspects and cover, inter alia, electrical, mechanical, and radiation hazards. Hence, these standards are applicable for a wide range of medical devices including clinical thermometers, infusion pumps, infant incubators, and laboratory centrifuges. 

The document also provides an exhaustive list of consensus standards recognized by the FDA and admissible in the context of the ASCA Pilot for demonstrating compliance with the safety and performance requirements. In particular, the information on the FDA recognition is provided in the Supplemental Information Sheet (SIS) accompanying each standard, together with the additional recommendations regarding the way the standard should be applied.

ASCA Accreditation of Testing Laboratories 

The present FDA guidance also describes the requirements and procedures related to the accreditation of testing laboratories by the appropriate accreditation bodies in accordance with Section 7 of the applicable international standard ISO/IEC 17011: Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies. According to the standard, the assessment described therein should take place at least once in two years. The same points should be considered in the context of the ASCA Accreditation allowing the accredited laboratories to conduct safety and performance testing. 

The document also outlines the particular requirements a testing laboratory shall meet in order to be eligible for an ASCA Accreditation to conduct the evaluation of safety and performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment under the ASCA Pilot. The Agency states that the accreditation process and the requirements associated thereto should be based on the ones set forth by the international standard ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories. At the same time, the additional recommendations developed by the FDA should be also taken into consideration. 

According to the FDA guidance, testing laboratories shall duly inspect the risk management file to be provided by the manufacturer of the medical electrical equipment in question. Such an inspection should be based on the following:

  • No judgments should be made regarding the adequacy of the risk management process implemented by the manufacturer, 
  • No judgments should be also made regarding the acceptability of risk or the decisions made by the manufacturer regarding this risk,
  • The scope of inspection should only cover the compliance with the requirements set forth by the standards IEC 60601/80601 or IEC 61010. 

One of the most important concepts related to the evaluation and assessment services provided by testing laboratories is the principle of impartiality. In accordance with this principle, in case if the testing laboratory offers any additional services (e.g. consulting, design, research), such services should be duly separated from the testing itself. In case if the testing is being conducted by the in-house laboratory of the manufacturer, such testing should be carried out in accordance with the appropriate internal policy establishing the procedures to be applied to ensure impartiality. 

The applicable standards also set forth certain additional requirements testing laboratory shall meed in order to be eligible to conduct testing and evaluation of medical electrical equipment. In particular, a testing laboratory shall:

  • employ technical personnel having the necessary qualifications and competences to conduct testing within the scope of accreditation of the testing laboratory. The personnel should be able to apply test methods and specifications required to evaluate compliance of the medical electrical equipment with the safety and performance requirements set forth by the applicable regulations and standards.
  • duly document the programs related to the personnel training and perform such training on a regular basis to ensure the awareness of the personnel with the new test methods and approaches. 
  • duly maintain all necessary equipment in proper working order in accordance with the scope of accreditation. The testing laboratory shall also perform the calibration on a regular basis in accordance with the intervals set forth for the appropriate type of equipment. It is also required to develop and implement the policy establishing the procedures to be performed to identify testing errors caused by incorrect calibration or operations of the equipment used for testing. Such a policy should also describe the way such errors could affect the accuracy and reliability of testing results.

Besides the points outlined here above, the present FDA guidance describes other technical and organizational measures to be taken by the testing laboratories to achieve and sustain compliance with the eligibility criteria to be accredited for safety and performance evaluation under the ASCA Pilot.

Premarket Submission Content 

In order to assist medical electrical equipment manufacturers in sustaining compliance with the applicable requirements, the FDA also provides additional clarifications and recommendations regarding the documents and information to be included in the premarket submission for FDA-recognized consensus standards in the ASCA Pilot. According to FDA guidance, the premarket submission should include: 

  1. Cover Letter (the particular recommendations regarding this document are provided in the general guidance on the ASCA Pilot Program). 
  2. Declaration of Conformity (the recommendations on the content of a declaration of conformity are provided in the FDA guidance dedicated to the use of voluntary consensus standards in premarket submissions for medical devices). According to the present guidance, the declaration of conformity shall contain such important details as the indication of the dates and locations the testing took place, confirmation of the use of the FDA-recognized consensus standard, and also the limitations on the validity of the declaration of conformity. 
  3. Supplemental Documentation including an ASCA summary test report to be provided to the medical electrical equipment manufacturer by the ASCA-accredited testing laboratory.

Summarizing the information provided here above, the FDA guidance on the application of consensus standards for medical electrical equipment in the context of the ASCA Pilot describes the way the FDA-recognized standards should be applied to demonstrate conformity with the applicable safety and performance requirements.

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