The U.S. FDA posted the policy and considerations final guidance for multiple function device products, which addresses an April 2018 draft guidance that drew substantial criticism from regulated entities. Despite criticisms of the agency’s use of the term “subset” in the draft in reference to intended use. The final guidance said that while the FDA does not regulate general-purpose computer platforms, the agency may nonetheless assess the impact of that platform on the safety and/or effectiveness of a device function-under-review. BioWorld will cover this story in greater detail in an upcoming issue.
The FDA announced it will convene a two-day meeting of the orthopedic and rehabilitation devices advisory committee to review the risk classification of five device types, including facet screw systems. The Sept. 8-9 meeting will be webcast, although the agency advised that potential viewers should check the Federal Register the day before the event to ensure they are up to date on any last-minute changes. Facet screws are currently unclassified, pre-Amendments devices for which the agency is proposing a class II risk designation, while the balance of the Sept. 8 agenda is for noninvasive bone growth stimulators, which may be down-classified from their current status as class III devices. On Sept. 9, the FDA will obtain feedback on proposed class II designations for three pre-Amendments devices: semi-constrained toe joint prostheses, intra-compartmental pressure monitors and intraabdominal pressure monitors.