Devices
A 6/22-7/5 FDA inspection at Hand Biomechanics Lab, Sacramento, CA, found Medical Device Reporting and Quality System Regulation violations in the firm’s manufacturing of bone fixation fastener systems. An 11/16 Warning Letter says specific violations were: * failing to submit a report to FDA no later
Devices
Simple Diagnostics has recalled three lots of Pharmacist Choice Alcohol Prep Pads, which were manufactured by China-based Foshan Flying Medical Products, due to sterility assurance and other quality issues. Using the suspect Alcohol Prep Pads could result in adverse events such as infections, according to a recall notice. To
Devices
A plan to end all use of dental amalgam in the European Union (EU) by 2022 was agreed to last week in Berlin, Germany, by representatives of EU governments, dentistry, environmental organizations, health professional associations, and consumer groups from across the continent, according to Washington-based Consumers for Dental Choice
Devices
FDA has issued a new guidance on “Technical Considerations for Additive Manufactured Medical Devices 3D Printing of Medical Devices.” The “leap-frog” guidance is intended to bridge today’s innovations with expected innovations coming down the road. FDA commissioner Scott Gottlieb says the new guidance helps the agency prepare for
Devices
FDA has issued a guidance on “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions,” which modifies the categorization of IDE devices used in clinical studies. Under the guidance, devices with an approved IDE fall into one of
Devices
FDA commissioner Scott Gottlieb has agreed to meet with Rep. Rosa DeLauro (D-CT) and other members of Congress to discuss the safety of Bayer’s controversial contraceptive implant Essure (see earlier story). DeLauro says the meeting was granted on the condition that women who have been affected by Essure
Devices
FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. An agency news release says that compared to other companion diagnostics previously
Devices
A CDRH 11/21 webinar described two guidances relating to the de novo program. A final guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation, provides updated recommendations for interacting with FDA, including what information to submit when seeking a path to market via the de novo classification
Devices
A 11/17 CDRH webinar provided an update on the Center’s digital health precertification pilot program. The agency says it wants to be transparent throughout the pilot process and will provide regular updates. At this point, it says, meetings have been held with all nine pilot participants to discuss
Devices
A 11/16 FDA webinar explained requirements in two recent final guidances on when to submit a 510(k) for a change to an existing device and when to submit a 510(k) for a software change to an existing device. During the program, CDRH acting associate director for regulations
Devices
FDA has issued a draft guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway. The document says use of the guidance is expected to reduce study-related costs and provide time savings
Devices
An FDA safety alert warns that dietary supplements containing biotin (vitamin B7) can cause clinically significant incorrect lab test results. The agency says it is seeing an increase in reported adverse events, including one death, related to biotin interference with lab tests. “Biotin in patient samples can cause falsely high
Devices
Sen. Chuck Schumer (D-NY) has called on the Federal Trade Commission to examine direct-to-consumer home DNA kits to ensure genetic information is not sold or shared with third parties without consumers’ informed consent. Schumer 11/26 cited the increasingly popular home genetic kits (Ancestry, 23andMe and MyHeritage)
Devices
FDA has released a guidance on “Pediatric Information for X-ray Imaging Device Premarket Notifications” that outlines the agency’s current thinking on information to include in 510(k)s for such devices that are indicated for pediatric populations or general use x-ray imaging devices when considerable pediatric use
Devices
FDA has cleared a Medicrea Group 510(k) for its IB3D range of 3D-printed Titanium interbody devices with its AdapTEK in-house additive manufacturing platform. The 3D printing allows surgeons to design implants with a range of different footprints, lordotic angles, heights, lateral windows and endplate surface structure, including
Devices
FDA has approved the RxSight Light Adjustable Lens and Light Delivery Device that can make small adjustments to an implanted lens after cataract surgery, allowing some patients to have better vision when not using glasses. An agency news release says the RxSight intraocular lens is made of a unique material
Devices
FDA has approved a Medtronic PMA for its Azure pacemakers with BlueSync technology. The devices are available in both single chamber and dual chamber models, and offer improved longevity, estimated at 13.7 years, according to the company. The new pacemakers also allow patients to have magnetic resonance imaging scans
Devices
FDA has issued a guidance, Unique Device Identification: Direct Marking of Devices, to assist industry, and particularly labelers, to understand agency requirements for direct marking of medical devices for unique device identification (UDI). The question-and-answer document defines some terms used in agency regulations on the UDI direct marking
Drugs
By unanimous consent, the Senate agreed 11/16 to a House bill leaving to FDA decisions for battlefield drugs and medical devices. The House adopted HR 4374, introduced by Rep. Greg Walden (R-OR) the day before the Senate vote. The bill is intended to correct a provision adopted by
Devices
FDA has cleared a Voluntis 510(k) for Insulia, a “digital companion” for people with Type 2 diabetes that the sponsor says can integrate Lilly’s Basaglar and Novo Nordisk’s Tresiba insulin products. According to the company, this now makes Insulia available for people using any brand of basal
Devices
The Federal Trade Commission (FTC) has finalized a consent order it says is designed to remedy the anticompetitive effects resulting from Abbott’s $8.3 billion acquisition of Alere. Under the order, the parties will divest two of Alere’s point-of-care medical device product lines — point-of-care
Devices
FDA has authorized Memorial Sloan Kettering Cancer Center’s IMPACT (integrated mutation profiling of actionable cancer targets) tumor profiling test, an in vitro diagnostic assay that can identify a higher number of biomarkers than may be found in various cancers with any test previously reviewed by the agency. IMPACT was