Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Healthcare Dive, in “FDA Issues Long-Awaited Draft Software Guidance in Overhaul of 16-Year-Old Policy,” by Nick Paul Taylor.
Following is an excerpt:
- FDA has belatedly published draft guidance on the content of premarket submissions for device software functions, moving it a step closer to the replacement of 16-year-old guidance.
- The draft covers the documents sponsors should include in submissions to enable FDA to evaluate the safety and effectiveness of device software functions. The guidance applies to all types of premarket submissions and includes both software in and software as a medical device (SiMD/SaMD).
- FDA committed to releasing a draft replacement for the current 2005 guidance as part of the MDUFA IV agreement but failed to deliver the document by the end of its 2019 financial year as planned. Bradley Merrill Thompson, an attorney at Epstein Becker Green, said the new guidance is sorely needed by the medical device industry. “In the realm of software, [16 years is] an eternity,” Thompson remarked.