Health Law Advisor

While FDA made a push last fall to explore the technical challenges associated with 3-D printed devices (holding a public workshop in October 2014), the Agency's planned guidance on the topic fell to the "B-list" in FDA's 2015 medical device guidance agenda. According to the agenda, the Agency will issue a draft guidance document on 3-D printing as "guidance-development resources permit." In light of the regulatory uncertainty facing 3-D printing stakeholders, this may seem like unwelcome news – but is it?

Recent comments from Agency officials suggest that immediate guidance is ...