MASSDEVICE ON CALL — The FDA released a spate of new guidances in the 1st half of 2014, several with important implications for medical device and digital health companies.
Law360.com picked out some of the highlights from the year, including measures that affect how healthcare companies can communicate over social media and new rules that relax oversight of healthcare data systems and clinical decision software.
In April the FDA announced that it would take a largely hands-off approach to clinical decision support software, programs that help physicians narrow down a patient’s diagnosis based on symptoms, according to the report (subscription required).
The agency issued guidance late in June that proposed “enforcement discretion” for medical device data systems, ruling that devices that simply collect and store information generated by other devices can skip the 510(k) process for premarket clearance. That guidance is a major boon for digital and mobile health companies looking to leverage data rather than generate it.
Also in June the FDA issued a pair of draft guidances to help medical device makers understand the agency’s thinking on social media communication, especially via channels, such as Twitter, that may put companies in a tricky spot by constraining characters allowed in a single post.
MassDevice.com picked out some additional recent FDA publications that could play an important role in medical device development.
Early in January the FDA issued draft guidance that would for the 1st time separate 510(k) regulation for over-the-counter blood glucose meters from those designed for clinical settings.
At the end of June the agency put the finishing touches on its unique device identifier guidance, condensing previous guidance into a single document that finalizes rules for the global UDI database and offers advice for initial submissions and other elements of the program.
But that’s not all. The FDA has been busy this year, having issued several additional reports and published new guidances this month.
A 510(k) proposal reported to Congress in February walked back some of the agency’s earlier guidance on changes to the medtech fast-track, clarifying the pathway rather than offering changes.
In March the FDA released a Q&A to clarify how device makers can apply for Humanitarian Device Exemption, a less-stringent review process for medical devices that treat rare diseases.
Just this week the watchdog agency issued a new final guidance to ban “split predicates” in 510(k) applications, banning companies from using separate predicates for technology and intended use when establishing substantial equivalence for a new device. Earlier in the month the FDA offered new guidance to clarify the agency’s risk/benefit evaluation process for technologies undergoing 510(k) review.
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