Labeling Errors Lead To Class I Recall For Baxter Software
The US FDA has designated a software application recall from Baxter Healthcare as class I, the agency’s highest-risk category.
You may also be interested in...
During a webinar hosted by the Alliance for a Stronger FDA, the US agency’s Deputy Commissioner Janet Woodcock discussed the FDA’s efforts to modernize how it collects and analyzes data.
While half of all medical devices in the US are sterilized with ethylene oxide, emissions from the gas pose potential environmental hazards that are attracting federal action.
The US FDA is now allowing users to submit 510(k), PMA, and other premarket applications through its Customer Collaborations Portal, which previously only allowed users to track submissions.