While a recent final guidance when a 510(k) is needed for software changes is helpful, a key industry lobbyist says it doesn't do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight.

The digital medtech sector is growing fast. As new companies enter the space, they are going to face oversight from a slew of government agencies and statutes. While FDA is an important focus for medtech, patient privacy and cybersecurity challenges for digital products raise other, significant compliance challenges. Medtech Insight discussed the range of hurdles the digital medtech industry faces with attorneys from Akin Gump.

While the US agency's final guidance on medical device accessories provides sponsors assurance the agency could be more lenient in classifying their products, an industry group leader says the guidance left a lot of unanswered questions that will continue to create uncertainty for companies.