Due to the ongoing COVID-19 pandemic, FDA has extended response due dates by 90 days for all Premarket Notifications (510(k)s), Premarket Approval (PMA) applications (original and supplements), Humanitarian Device Exemption (HDE) applications (original and supplements) and De Novo classification requests that were originally due on or before June 30, 2020. Other types of responses are due as soon as possible.
Additionally, FDA encourages device manufacturers to monitor cleanroom controls such as air filtration, positive air pressure and movement of air to ensure proper function and use validated cleaning processes within the cleanroom at defined intervals and frequency as well as continue other OSHA recommended procedures to protect employees against COVID-19 as found in the document OSHA: Guidance on Preparing Workplaces for COVID-19,” and follow applicable OSHA standards and guidance where appropriate.
EAS Consulting Group offers a variety of services to the medical device industry including assistance with study design, preparation and submission of device applications as well as assessment of cleanroom protocols and validation measures. During this time of social distancing, we offer these services remotely through desk audits and web-based meetings. Call us for more details.
Lastly, due to the ongoing COVID-19 public health emergency, FDA’s CDRH will be conducting all scheduled in-person meetings via teleconference through May 31, 2020. While FDA believes it has contacted all parties affected, should you have a scheduled meeting and have not heard from FDA, you are encouraged to reach out to the CDRH staff liaison for more information.
Bryan J. Coleman
Senior Director for Pharmaceutical and Device Consulting Services