, 6 tweets, 2 min read Read on Twitter
THREAD: Update on Shutdown - Questions are being raised around FDA’s efforts to support device safety during the partial lapse in funding, especially with respect to post-market surveillance. I want to provide some background:
First, I want to reassure everyone that while it’s not business as usual at the agency, we are continuing to prioritize our device safety work both before AND after medical devices come to market.
With respect to post-market efforts, the agency is currently monitoring ALL medical device adverse events it receives, looking for concerns and signals that need to be addressed. If we find issues, we can and will act to protect Americans from imminent threats to health.
We also continue to process, review and classify all high-risk (Class I) and moderate-risk (Class II) medical device recalls. We are then ensuring that the necessary steps are taken for those that pose an imminent threat to human life.
We are also continuing to conduct for-cause inspections of devices facilities when the agency believes an imminent threat to life or health exists, and working to bring back online surveillance inspections of high-risk devices as we have already announced for foods.
I want to personally thank the #FDA colleagues overseeing this important device safety work -- even during these challenging times -- to ensure that our critical consumer protection work continues, and make sure that we are able to secure our public health mandate.
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