FDA Issues Bone Anchor Draft Guidance for Marketing Submissions
The FDA has published a draft guidance document providing recommendations for marketing submissions of bone anchor devices.
This publication is updating the 1996 guidance to clarify and provide current thinking on the recommended content for a bone anchor marketing submission, including performance testing recommendations and device description.
These devices are indicated for attachment of soft tissue to bone.
This guidance is issued for comment purposes only.
FDA Classifies Ischemic Stroke Treatment Device as Class II
The FDA issued a final order classifying neurovascular mechanical thrombectomy devices for acute ischemic stroke treatment as Class II devices with special controls.
This type of device mechanically removes blood clots to restore blood flow in the neurovasculature.
Firms that intend to market this type of device must submit a premarket notification and comply with the special controls listed in the final order.
A public workshop will be held on Feb. 2, 2017, from 8 a.m. to 5 p.m. EST, to obtain stakeholders’ input on the coordination of registries for these devices.
FDA Announces Changes to Consensus Standards
The FDA announced additions, withdrawals, corrections, and revisions of certain consensus standards the agency recognizes for premarket submissions and other requirements for medical devices.
The announcement describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
The announcement also lists additional standards not previously recognized by FDA.
FDA Reclassifies Pedicle Screw Systems
The FDA has issued a final order to reclassify pedicle screw systems, from a Class III device to Class II.
The agency has also renamed the device to thoracolumbosacral pedicle screw systems. This order is effective on December 30, 2016.
Medical Carts Have Potential Fire Risk
The FDA has issued a letter warning health care facilities of potential safety risks associated with battery-powered mobile medical carts.
The FDA has received medical device reports of hospital fires and other health hazards associated with batteries used in mobile medical carts and their chargers. In these events, a range from smoke production and overheating to equipment fires and explosion can occur with lithium, lead acid and other types of batteries.
HAS Grants Reimbursement to Theraclion
The French’s National Health Authority has given a favorable opinion for reimbursement to Theraclion’s Echopulse for the treatment of non-malignant breast tumors.
The two main objectives of this system are to accelerate patient access to medical innovations and support business development. The study has been approved to commence in 12 hospitals across France.
EU Grants Marketing Approval to HiberGene
Dublin, Ireland-based HiberGene Diagnostics has earned CE Mark approval for its HG C. difficile test.
HG C. difficile enables the detection of the bacterium, Clostridium difficile (C. difficile), from stool samples in under 60 minutes. The launch of HG C. difficile is the third in HiberGene’s.