Medical Device Labeling Regulation Changes by FDA for COVID 19 period
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 |
|
II. Disinfectant Devices | |||
1. Chemical/Physical Disinfectant Devices | |||
Cleaning accessories for endoscope | FEB | II |
|
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 |
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:
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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