Covid-19
 

Medical Device Labeling Regulation Changes by FDA for COVID 19 period

April 16, 2020

FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19. In this regard FDA has implemented few guidance documents immediately without prior public comment, because this is not feasible or appropriate at this pandemic time, but it remains subject to comment in accordance with the Agency's good guidance practices. As recommended by FDA the devices submission would be required as per Quality System Regulation requirements (21 CFR Part 820 {21 CFR Subpart K - 820.120 Device labeling & 820.130 Device packaging Control}), Reports of Corrections and Removals requirements (21 CFR Part 806 {reporting information}), and Label to bear a unique device identifier (21 CFR Part 830 and 21 CFR 801.20) regulations as necessary. The recommended guidance document contains proposed changes in both the device technical function and labeling context (including methods, standards, etc).

Below is one of the medical devices type as per new recommendations.

Modifications for Sterilizers, Disinfectant Devices, and Air Purifiers:

FDA has recommended standards (TABLE 1) and labeling modifications (TABLE 2) on sterilized or disinfected conditions to patients and healthcare providers for usage of sterilizers, disinfectant devices, and air purifiers during this public health emergency.

TABLE 1: Modifications/applied standards for Sterilizers, Disinfectant devices, and Air purifiers

Device Type Product Code Device Classification FDA-Recommended standards for Sterilized or Disinfected Devices on Indication or functionality
I. Sterilizers
Endodontic dry heat sterilizer KOK III
  • Steam Sterilizers
    • ANSI/AAMI ST8:2013 Hospital Steam Sterilizers
    • ANSI/AAMI ST55:2016 Table-Top Steam Sterilizers
    • ANSI/AAMI ST79:2019 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.
  • Dry Heat Sterilizers
    • AAMI ST50:2004 (R2018) Dry Heat (Heated Air) Sterilizers
    • ANSI/AAMI ST40:2004m (R2018) Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Health Care Facilities
  • Ethylene Oxide Sterilizers
    • ANSI/AAMI ST24:1999 (R2018) Automatic, General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities, 3ed.
    • ANSI/AAMI ST41:2008 (R2018) Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness
  • Other Sterilizers
    • ANSI/AAMI/ISO 14937 Sterilization of Health Care Products — General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
  • Chemical Indicators
    • ANSI/AAMI/ISO 11140 – 1 Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements
  • Sterile Packaging
    • ANSI/AAMI/ISO 11607-1 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
    • ANSI/AAMI/ISO 11607-2 Packaging for Terminally Sterilized Medical Devices
  • Rigid Sterilization Containers
    • ANSI/AAMI/ISO ST77:2013 Containment Devices for Reusable Medical Device Sterilization
  • Biological Indicators
    • ANSI/AAMI/ISO 11138 Sterilization of Health Care Products—Biological Indicators Series
    • ANSI/AAMI/ISO 14161 Sterilization of Health Care Products — Biological Indicators — Guidance for the Selection, Use and Interpretation of Results
II. Disinfectant Devices
1. Chemical/Physical Disinfectant Devices
Cleaning accessories for endoscope FEB II
  • AAMI ST58:2013 (R2018) Chemical Sterilization and High-Level Disinfection in Health Care Facilities
  • Association of Official Analytical Chemists (AOAC) 6.3.05:2013 Official Method 966.04 Sporicidal Activity of Disinfectants
  • AOAC 6.3.06:2012 Official Method 965.12 Tuberculocidal Activity of Disinfectants
  • AOAC 6.3.02:2006 Official Method 955.17 Fungicidal activity of Disinfectants Using Trichophyton Menta grophytes
  • AOAC 6.2.01:2013 Official Method 955.14, Testing Disinfectants Against Salmonella Choleraesuis, Use-Dilution Method
  • AOAC 6.2.04:2013 Official Method 955.15, Testing Disinfectants Against Staphylococcus Aureus, Use-Dilution Method
  • AOAC 6.2.06:2013 Official Method 964.02, Testing Disinfectants Against Pseudomonas Aeruginosa, Use-Dilution Method
Medical devices sterilant MED II
Medical devices disinfectors MEC II
(exempt from premarket review unless indicated for high level disinfection or for use on endoscopes and accessories)
Medical devices cleaners MDZ II
High level disinfection reprocessing instrument for ultrasonic transducers, mist OUJ II  
High level disinfection reprocessing instrument for ultrasonic transducers, liquid PSW II
II. Ultraviolet (UV) Disinfecting Devices
UV radiation chamber disinfection devices, OSZ II
III. Air Purifiers For the purposes of this guidance, FDA recommends that manufacturers of air purifiers evaluate or perform the following:
Medical recirculation air cleaner FRF II
  • Demonstration of a 4 log reduction (through a combination of capture or destruction) of claimed particulates.
  • If intended for use against bacteria, effectiveness against representative gram positive and gram negative species.
  • If intended for use related to SARS-CoV-2, effectiveness against a representative virus
  • If the device generates ozone, the maximum acceptable level of ozone per 21 CFR 801.415.
If intended for use in areas that have a sterile field or controlled air flow, a risk assessment to address turbulent air flow and/or potential site contamination.
Medical UV air purifier FRA II

Table 2: Labeling Modifications for Sterilizers, Disinfectant Devices, and Air Purifiers:

FDA RECOMMENDED LABELING MODIFICATIONS LABELING IMPACT
(Yes/No)
IFU Art Work
1. A clear description of the available data on the device’s new indications or functions related to SARS-CoV-2 or co-existing conditions, such as:
a) Device performance; and
b) Potential risks (e.g., risk of UV exposure)
Yes Yes
(indication statement)
2. -A clear distinction delineating FDA-cleared or FDA-approved indications from those that are not FDA-clared or FDA-approved. In addition, FDA recommends the labeling include a general statement about changes that have not been cleared by FDA. Yes Yes
3. For all disinfectant devices, a clear statement of the level of disinfection. Yes Yes
a) A caution that UV disinfection will reduce the number of pathogens on the device, but it will not eliminate them completely. Yes No
b) A statement that the device is an adjunct to currently existing reprocessing practices and not a replacement or modification to such practices. Yes No
c) A statement regarding the time, distance, and maximum area over which the device has been evaluated for effectiveness. Yes No
d) An appropriate UV hazard warning label. Yes Yes
e) Identification of the expected UV lamp operational life and instructions for procedures on replacement of the UV lamp when needed. Yes No
f) Procedures to follow if the UV lamp malfunctions or fails. Yes No
g) Description of the preparation of equipment or the room for disinfection Yes No
h) A statement that the equipment intended to be disinfected is UV compatible. Yes No
i) Identification of the UV dose. Yes No

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