Bone Anchors: FDA Finalizes 510(k) Guidance

Regulatory NewsRegulatory News | 02 March 2020 |  By 

The US Food and Drug Administration (FDA) on Monday finalized its recommendations for medical device makers to follow to support 510(k) submissions for bone anchors, also known as suture anchors, that are intended to attach soft tissue to bone.
Specifically, the 17-page guidance applies to devices classified under product codes MAI and MBI for biodegradable and nonbiodegradable soft tissue fastener and fixation devices. The guidance does not apply to anchors that attach bone to bone or anchors meant to be used with artificial tendons or ligaments.
FDA says it revised the guidance in response to comments submitted to the draft version. Only two comments were submitted to the public docket for the draft guidance, one from the Advanced Medical Technology Association (AdvaMed) and one from an individual.
FDA revised the guidance in response to AdvaMed’s request to allow device makers to demonstrate substantial equivalence to predicate devices cleared under other product codes other than MAI and MBI.
FDA also added to its recommendations for shelf life and packaging to reference both parts 1 and 2 of the ANSI/AAMI/ISO 11607 standards for packaging sterilized medical devices and to point to the FDA-recognized ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Additionally, the final guidance references an additional consensus standard for degradation testing, ISO 13781: Implants for surgery —Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing, and allows for sponsors to compare peak pullout force to “pre-specified acceptance criteria and test set-up parameters based on clinically relevant historical data,” in lieu of comparing peak pullout force to a “legally marketed predicate with equivalent indications for use and technological characteristics.”
FDA also updated the final guidance to refer companies interested in submitting data from foreign clinical studies to its guidance on acceptance of clinical data for medical device submissions and to explain that an investigational device exemption (IDE) “would not likely be required” for real-world data collection for a legally marketed device “being used in the normal course of medical practice.”


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