Devices
In a 2/13 Warning Letter, FDA says Dr. Mark Berman, Beverly Hills, CA, has been manufacturing a medical device known as the Pocket Protector, an expanded-polytetrafluoroethylene pouch used to line the inside of a breast pocket during breast augmentation procedures. The letter cites many of the marketing claims
Drugs
Public Citizen says that unless an FDA proposed rule on institutional review board (IRB) waiver or alteration of informed consent for minimal risk clinical investigations is clarified, it could increase the risks to human subjects while undermining their right to informed consent before being enrolled in clinical trials. The group’
Drugs
FDA is permitting marketing of Tandem Diabetes Care’s t:Slim X2 insulin pump with interoperable technology for delivering insulin under the skin for children and adults with diabetes. An agency announcement says this new type of pump, an alternate controller enabled (ACE) infusion pump, is the first interoperable pump,
Devices
FDA has sent LC Medical Concepts a 1/31-dated Warning Letter after a 10/2018 inspection of the firm’s Rochester, NY, medical device operations found GMP concerns with the manufacturing of negative pressure wound therapy kits. The agency cited the company for failing to adequately validate with a
Devices
Attorney Adrienne Lenz (Hyman, Phelps & McNamara) says that while industry may feel that under the FDA 2/5 final guidance on least burdensome provisions it is continually being asked for more information, data, and studies to support their devices, “the final guidance, by way of sharing examples where FDA
Devices
FDA has granted Neurotech Pharmaceuticals a fast track designation for Renexus (NT-501) for treating macular telangiectasia type 2 (MacTel). Renexus is a cell-based drug delivery system. Human-derived cells encapsulated in a semipermeable hollow fiber membrane device release ciliary neurotrophic factor (CNTF), which is intended to reduce photoreceptor
Devices
FDA has granted BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a traumatic brain injury. The device is designed to measure the body’s response to trauma and provide a rapid point-of-care test result in less than two
Devices
FDA has approved an Orthofix Medical PMA for the M6-C artificial cervical disc for patients suffering from cervical disc degeneration. The device was developed by Spinal Kinetics, a company acquired by Orthofix 4/2018. The next-generation artificial disc is designed to restore physiologic motion to the spine, and
Devices
FDA has released a guidance entitled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” The agency says the devices identified in the guidance are sufficiently well understood and do not require premarket notification (510(k)) to assure their safety and effectiveness. Until the publication of a final
Devices
FDA has approved a Medtronic PMA for its Pipeline Flex embolization device. Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments, Medtronic says the new indication opens options for patients
Devices
FDA says it is working to raise awareness of the association between all breast implants, regardless of filling or texture, and breast implant associated-anaplastic large cell lymphoma (BIA-ALCL). An agency letter to healthcare providers says FDA has received reports indicating that patients with breast implants have an increased
Drugs
FDA has issued a draft guidance, Principles of Premarket Pathways for Combination Products, to provide the agency’s current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. “This guidance offers general, high-level information relevant to combination products,
Devices
FDA has classified as Class 1 an Edwards Lifesciences recall of its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufactured between 12/26/2017 and 4/19/2018. An FDA notice says the recall is due to incorrect assembly and reversal of the catheter tubes (lumens). “If the
Devices
FDA has classified as Class 1 a Smiths Medical recall of its sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (bacillus infantis and staphylococcus epidermidis) from damage to the containers used to package the finished products. Product use in patients could result
Devices
FDA has published a final guidance entitled The Least Burdensome Provision: Concept and Principles, to describe the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles, as required by Congress in the FDA Modernization Act of 1997 for medical device premarket
Devices
Federal Register notice: FDA has posted a guidance on Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection that provides recommendations to facilitate industry development and validation of assays for assessing the immunogenicity of such products during clinical trials. The document includes guidance on
Devices
Terrific Care/Medex Supply has recalled all lots of Roche Diagnostics’ CoaguChek XS PT Test Strips that were manufactured 10/2017 to 5/2018 due to inaccurate International Normalized Ratio test results, when compared to laboratory results. The test strips may provide results that are higher than the actual INR,
Devices
FDA has cleared a Qualigen 510(k) for its FastPack IP Sex Hormone Binding Globulin Immunoassay, a biomarker used in diagnosing and treating men’s health. The FastPack IP system is described by the company as a fully automated, highly efficient blood analyzer that provides rapid, quantitative immunoassay results at
Devices
Breakthrough device designation requests are confidential and will not be maintained in an FDA database. That’s one of the insights gained by attorney Rachel Hunt (Hyman, Phelps & McNamara) from the question and answer period following an FDA Webinar on the program. Writing in her firm’s FDA Law
Devices
FDA is providing safety information and recommendations to help users of infusion pumps, rapid infusers, fluid warmers, and their accessory devices reduce the risk of air being introduced in a blood vessel (air-in-line) and air embolism associated with the devices. An agency safety communication says that while air-
Devices
AdvaMed praises FDA for reopening the comment period on two coronary drug-eluting stent guidances that are 10 years old. In its comment letter, the association says that FDA and industry have learned a lot in the last 10 years about the design, development, and production of high quality products
Devices
Retired CDRH branch chief Morris Waxler, who approved the original LASIK vision correction indication, is urging the Center to stop deceiving the public about adverse events (AE) associated with a laser procedure called the small incision lenticule extraction (SMILE) that is intended to reduce or eliminate nearsightedness in certain patients