Drugs
House Energy and Commerce Committee chairman Fred Upton (R-MI) and ranking member Frank Pallone, Jr. (D-NJ) have introduced The FDA Cross-Center Collaboration Act of 2016, legislation to encourage collaboration between product centers at the agency. The bill would require FDA to establish one or more “Intercenter Institutes”
Devices
FDA has cleared a Masimo 510(k) for its O3 regional oximetry. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain due to various factors,
Devices
Although CDRH has repeatedly refused in the face of mounting adverse reaction/injury reports to remove the LASIK indication from lasers labeled for that vision-enhancement indication, Center director Jeffrey Shuren 6/10 took less than 40 minutes to tell a LASIK activist CDRH would “look into” a patient’s
Devices
FDA has told Terumo Cardiovascular Systems that it has successfully completed its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, MI manufacturing facility, including Terumo Advanced Perfusion System 1, that were impacted by a 2011 consent decree. As a result, all shipping restrictions
Devices
FDA has issued a draft guidance, Dissemination of Patient-Specific Information from Devices by Device Manufacturers, to “facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients.” The document notes that patients increasingly are seeking to
Devices
FDA has cleared an Astute Medical 510(k) for the NephroCheck Test Kit that will extend its shelf life from 16 weeks to 12 months when refrigerated. The test is designed to help determine if certain hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI)
Devices
FDA has cleared a Sandstone Diagnostics 510(k) for its Trak Male Fertility Testing System, an at-home diagnostic for couples to measure semen quality at home as they try to conceive. The device uses centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges, according to
Drugs
Sen. Dan Coats (R-IN) has introduced S. 2998, the Ensuring Patient Access to Critical Breakthrough Products Act, to “establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries.” In a statement, the senator says that “researchers and entrepreneurs
Devices
Baxter says that unauthorized third-party services who refurbish, recondition, rebuild, remarket, remanufacture, and service medical devices “generally lack the product and process knowledge and controls of the original equipment manufacturer. Unauthorized service activities, therefore, may create significant risks for patients, despite the best intentions and efforts of the third-
Devices
FDA has given Invacare information on additional steps the company must take to meet design control requirements at its Taylor Street facility in Elyria, OH. The company reported in an SEC filing that FDA clarified its requirement for Invacare to complete the remediation of certain design history files referenced in
Devices
Researchers at the Department of Energy’s Lawrence Berkeley National Laboratory are helping to develop and test materials for a new device that can be inserted into a vein to soak up, like a sponge, tumor-fighting drugs before they can widely circulate in the bloodstream and cause side effects.
Devices
Members of the FDA Circulatory System Devices Panel met 6/2-6/3 to discuss and make recommendations about aerosolized transmission of nontuberculous mycobacteria (NTM) from contaminated water inside heater-cooler devices into the operating room environment and sterile field and ultimately into patients undergoing open chest surgical procedures. A
Devices
Attorney John Sullivan, writing in a Drug & Device Law blog post, praises a Minnesota state court decision that all claims in a suit against Medtronic are preempted by federal regulations. The case involved allegations that the plaintiff had complications from a pain pump implant. The suit alleged a number
Devices
Reps. Michael Fitzpatrick (R-PA) and Louise Slaughter (D-NY) have introduced two bills to improve medical device safety and allow those harmed by devices to seek legal recourse. Fitzpatrick has been an outspoken advocate for FDA and medical device reform and continues to call for an Energy & Commerce
Devices
A 11/30-15-1/21/16 FDA inspection at Spectranetics Corp., Colorado Springs, CO, found Quality System Regulation and other violations in the firm’s manufacturing of lead management disposable catheter lines, including laser sheath device products, specifically the GlideLight and SLS II sheaths. A 5/23 Warning Letter
Drugs
With the number of shipments of FDA-regulated products into the U.S. more than doubling from 15 million to more than 34 million in the past decade, the agency is implementing initiatives to keep pace, according to deputy commissioner for global regulatory operations and policy Howard Sklamberg. Writing in
Devices
FDA has cleared a MOOE Orthopedics 510(k) for the DynaMOE Nitinol Compression Screw. The device “utilizes the superelastic properties of nitinol to provide higher levels of compression than contemporary bone screws,” according to the company. “During manufacturing, the dynaMOE Nitinol Compression Screw is stretched and held in an elongated
Devices
FDA has sent Zimmer Biomet a Warning Letter related to GMP deficiencies observed during a Quality System inspection in January at the company’s Montreal, Canada manufacturing facility. The company says the facility is the principal location of its wholly-owned subsidiary, ORTHOsoft, Inc. At the conclusion of the inspection,
Devices
FDA has cleared a Cereve de novo petition to allow marketing of its Sleep System, a prescription device that the company says is intended to reduce latency to Stage 1 and Stage 2 sleep for people with insomnia. The device was developed based on research at the University of Pittsburgh
Devices
FDA has cleared a First Ray 510(k) for the SpeedButton System for attaching soft tissue to bone. “Reattachment of ligaments and capsular tissue to bone using conventional suture anchors is problematic in the presence of decortication at the attachment site,” the company says. “Quality of the fixation may be
Devices
Paradigm Spine has agreed to pay the U.S. government $585,000 to resolve allegations under the False Claims Act that the company caused health care providers to submit false claims to Medicare and other federal health care programs by marketing the company’s coflex-F device for unapproved uses.
Devices
The average time for FDA to review and make a decision on 510(k)s dropped to 122 days in FY 2015, which is five days faster than 2014, and 23 days (16%) faster than in 2012 when it took 145 days, according to just-released medical device user fee