US FDA publishes new guidance documents and issues ESD ban

The US FDA recently published guidance documents on bone anchors and soft contact lenses, and it banned a therapeutic use of one medical device category.

New guidance documents for 510(k) clearance

The regulatory body released a final guidance on Bone Anchor – Premarket Notification (510(k)) Submissions. This guidance provides nonbinding recommendations for 510(k) submissions for bone anchors, otherwise known as suture anchor devices (product codes MAI and MBI), intended to attach soft tissue to bone. It also examines specific testing methods, with advice on how manufacturers can demonstrate substantial equivalence to predicate devices. A draft of this document was issued on January 3, 2017.

The FDA additionally issued a draft guidance titled Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway. This document, which is open to public comment until May 4, 2020, identifies performance criteria and testing methods that such devices need to satisfy 510(k) clearance. It is an addition to the list of draft guidance documents from September 2019 over certain Class II device categories considered appropriate for the Safety and Performance Based Pathway.

Ban on one use of electrical stimulation devices (ESDs)

Finally, the FDA officially banned electrical stimulation devices (ESDs) as a treatment for self-injurious or aggressive behavior. The decision was ascribed to the existence of physical and psychological risks linked to the devices that could not be addressed by modified labeling. Such devices were only used for this purpose in one Massachusetts facility, on students who possessed intellectual disabilities or registered on the autism spectrum. The ban applies nationwide and goes into effect on April 6, 2020. In order to ease the transition, the facility that already uses the devices will be allowed to continue their use on specific patients until September 2.

Related US FDA regulatory information from Emergo:

• US FDA 510(k) registration consulting for medical device and IVD companies
• FDA submission consulting for medical devices and IVDs
• FDA medical device classification primer
• Whitepaper: Preparing a US FDA 510(k) submission