Hello RAPS members,
23rd of April, FDA released enforcement policy for imaging systems during the COVID-19 public health emergency.
The enforcement policy allow huge flexibility on design modification of imaging systems to combat with the virus including hardware and material/components changes.
Eventhough 510(k) review is exempted for certain imaging systems according to the policy during the emergency period, I believe that NRTL certification requirements on critical components change is still applied.
Does anyone know that OSHA has published similar measure that FDA did?
COVID-19 Imaging Equipment Policy
| U.S. Food and Drug Administration |
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| COVID-19 Imaging Equipment Policy |
| Docket Number: FDA-2020-D-1138 Issued by: Center for Devices and Radiological Health, Office of Product Evaluation and Quality The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. |
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Jeongpyo Hong
Sr. Professional, Regulatory Affairs
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