Devices
FDA has issued three guidances based on the just-approved MDUFA 4 reauthorization giving the effect on the FDA review clock and goals of agency and industry actions on 510(k) submissions, PMAs approvals, and de novo classification requests. In each instance, the guidance details performance goals that were established
Devices
The HHS Inspector General (IG) says in a report that services related to the replacement of seven recalled and prematurely failed medical devices cost Medicare $1.5 billion during calendar years 2005 through 2014. The IG also estimated $140 million in beneficiary copayment and deductible liabilities related to the recalled
Devices
FDA has made available a draft guidance on “Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.” The document provides detailed recommendations for device makers seeking marketing clearance of such devices, and for deciding when a device modification to a diagnostic ultrasound device can be made without the need for submission
Devices
FDA has posted a guidance on “Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A.” Section 517A of the Food, Drug, and Cosmetic Act was amended by the recent 21stCentury Cures Act of 2016 to allow requests for documentation of rationales for “significant decisions” and requests
Devices
FDA has released a guidance on “Display Devices for Diagnostic Radiology” that is intended to assist industry in preparing premarket notification submissions. The document applies to current technologies, but it says FDA may request new or alternative test methods to fully evaluate the safety and effectiveness of future display technologies.
Devices
FDA is reminding medical device makers about this week’s beginning of National Cybersecurity Awareness Month and to “remain constantly vigilant” about potential vulnerabilities when it comes to device technology. “As technology continues to connect, transform and evolve at a rapid pace, cybersecurity threats are never far behind,” an agency
Devices
FDA has made available a guidance on “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.” The document provides an overview of the mechanisms available to applicants to request feedback from the agency a potential medical device submission. It covers
Devices
FDA has made available a guidance on “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.” The document is intended to help FDA staff develop a request for additional information (deficiency in the submission) needed to make a decision on a medical device marketing application in accordance
Devices
FDA has cleared a K2M Group Holdings 510(k) for its Yukon Oct Spinal System, a device intended to facilitate fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine. The device features “newly designed top-loading, high angulation, polyaxial screws that provide up to 105 degrees
Devices
FDA is alerting vascular surgeons about concerns regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for aneurysm repair procedures that treat abdominal aortic aneurysms and aorto-iliac aneurysms. In a 9/28 letter to healthcare professionals, FDA says recent information from several sources suggests
Devices
FDA has cleared an Expanding Orthopedics 510(k) for the FLXfit 15 3D Expandable Cage System for restoring lumbar lordosis while controlling sagittal and coronal alignment. The device comes in different length options with infinitely adjustable expansion and lordosis correction of up to 4mm and 15mm, according to the company.
Devices
A California federal court has dismissed a whistleblower’s complaint charging that Medtronic obtained marketing approval for some of its spinal implant products by deceiving FDA as to the products’ intended use and that the company promoted the products for off-label use. Attorneys Anne Walsh and Andrew Hull (Hyman,
Devices
FDA has cleared a Hologic 510(k) for the body laser contouring product SculpSure to treat a double chin (submental area). The device is also cleared to treat the abdomen, love handles, back, and inner and outer thighs. Clearance was based on data from a 57-person clinical trial where
Devices
FDA has approved an Abbott Diabetes Care PMA for the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a fingerstick blood sample. The device reduces the need for fingerstick testing by
Devices
CDRH director Jeffrey Shuren and two other Center executives say they have seen increasing evidence of the benefits of soliciting patient feedback through the Patient Preference Initiatives that was launched in 2015. Writing in an FDA Voice article, Shuren and his colleagues say that in August the Center cleared an
Drugs
Public Citizen says there is no justification for FDA not seeking public input before issuing a final guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” In its comments, the advocacy group says FDA reported it had determined
Devices
In its Pulse of the Industry 2017, the EY medtech consulting firm says it’s only a matter of time until FDA enforces stringent regulations for the security of medical devices. The report notes that in 8/2017, the agency demonstrated how closely it continues to monitor potential cyber vulnerabilities,
Drugs
FDA has denied a US WorldMeds 7/21/15 petition asking that the agency require specific conditions for any application for a drug-device combination product containing apomorphine, intended for use in the advanced Parkinson’s disease population. Specifically, the petition asked that FDA: * require applicants to demonstrate that their
Devices
The Justice Department has told the 3rd Circuit Court of Appeals that a federal district court decision in a case involving Smith & Nephew hip replacement and resurfacing procedure medical devices held that some tort claims are expressly preempted, when they are not. “To the extent these claims are not
Devices
FDA commissioner Scott Gottlieb says the agency’s new “Pre-Cert for Software” pilot program is moving forward with the selection of nine company participants in the program — Apple, Fitbit, Google, Johnson & Johnson, Phosphorus, Roche, Samsung, Tidepool, and Verily. Under the program, CDRH will become a “certifier of firms
Devices
FDA has accepted for review a TherOx Inc. PMA for its Supersaturated Oxygen (SSO2) Therapy system, intended for use in reducing infarct size and improving outcomes in anterior acute myocardial infarction (AMI) patients treated within six hours of symptom onset. While percutaneous coronary intervention is the standard of care in
Devices
FDA has updated a 2016 safety alert to transplant surgeons and cardiologists about additional data that continue to indicate that there is a higher mortality rate for a subgroup of patients requiring pre-implant circulatory rescue interventions when using SynCardia’s Temporary Total Artificial Heart Companion 2 Driver System, as