Drugs
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) have released their ideas for Cures 2.0 legislation to update the 21st Century Cures Act. Upton and DeGette say (contains link to Cures 2.0 document) they are looking for feedback on their proposal and new ideas to consider
Devices
FDA 11/25 announced its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single-use medical devices using fixed chamber ethylene oxide (EtO) to submit a “master file” when making certain changes between sterilization sites or to sterilization processes that utilize reduced EtO
Devices
FDA has cleared a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and treating stress, mixed and mild-to-moderate urgency urinary incontinence in women. The device uses Renovia’s patented movement-based sensor and app technology to provide women real-time
Devices
FDA has posted a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting, which recommended (see earlier story) that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam Companion user interface. The device works by guiding users through the exam workflow with precise questions about the patient, for example, a patient’s electrocardiogram waveform for a
Drugs
FDA has issued a draft guidance, Transdermal and Topical Delivery Systems—Product Development and Quality Considerations, with recommendations for applicants and manufacturers of transdermal and topical delivery systems regarding the pharmaceutical development and quality information to include in NDAs and ANDAs. The document specifically discusses the agency’s current thinking
Devices
An 11/6 CDRH Webinar presented background on the Center’s Safer Technology Program for Medical Devices (STeP) that is part of a draft guidance outlining the agency’s vision for the program. Once finalized, STeP will be a voluntary pathway for certain medical devices that are expected to significantly
Devices
FDA has cleared a Carestream 510(k) for its Dual-Energy imaging technology and its Focus 35C Detector with Image Suite Software for medical imaging. The company says the device uses two filter materials that are automatically switched between the high- and low-energy exposures to produce a soft-tissue-
Drugs
A 4/15-4/30 FDA inspection at Apothecus Pharmaceutical, Hicksville, NY, found significant violations of current good manufacturing practice (CGMP) regulations for combination products. Specific violations listed in an 11/8 Warning Letter were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Devices
FDA says four reagent kits manufactured and distributed by Carolina Liquid Chemistries Corp., Winston Salem, NC, are adulterated and misbranded. A just-released 7/31 Warning Letter says the firm does not have a 510(k) or PMA for the kits. The letter says the firm distributes the kits with
Devices
CDRH Office of Product Evaluation and Quality technical guidance specialist Jason Ryans says the purpose of the new safety and performance-based pathway is to establish a voluntary more modern 510(k) pathway for demonstrating safety and effectiveness for certain well-understood devices. Speaking during a CDRH 11/7 Webinar,
Devices
An FDA device safety update about intra-aortic balloon pumps by Getinge’s Maquet/Datascope shutting down while running on battery power says the agency has received dozens more reports since an 11/2018 alert was issued. The malfunction can lead to the pumps’ stoppage and loss of hemodynamic support,
Devices
FDA’s Immunology Devices Panel of the Medical Devices Advisory Committee last week recommended that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials when conducting dental restoration procedures. The panel agreed that FDA’s latest literature review
Devices
FDA has approved a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. Cerapedics’ submission requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the
Devices
CDRH has established a “Patient and Caregiver Connection” program to obtain feedback from these stakeholders on their experiences living with a condition or using medical devices. Certain partner organizations collect feedback on specific issues from their members and share that feedback with CDRH. “This patient feedback on the impact of
Devices
FDA has approved CooperVision’s MiSight, the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of eight and 12 years old. The single use, disposable, soft contact lens is intended to be discarded at the end of each day, and is not
Devices
FDA has cleared a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will reduce the number of parts that need to be cleaned and disinfected in between uses. The Pentax Medical Video ED34-i10T2 is intended to provide visualization and access
Devices
FDA has cleared an Ultromics 510(k) for its image analysis system EchoGo Core, which uses artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans. Traditional echocardiography relies on the “expert eye” of clinicians to identify disease under a time-consuming and highly variable process,
Devices
Retired CDRH branch chief Morris Waxler, who voted to approve LASIK eye surgery when he worked for the agency, now tells CBS News the vote was a mistake and LASIK should be taken off the market. “I reexamined the documentation … and said, ‘Wow, this is not good,” Waxler told the
Devices
FDA has cleared a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden (TMB) in cancer tissue. The company describes the assay as the first “custom-targeted whole exome sequencing platform to report both overall tumor mutation burden
Drugs
The Stericycle Expert Solutions First Quarter recall index says drug recalls decreased 6.5% to 72, the second-lowest number in the past 12 quarters. However, recalled units stayed high at just over 22 million. “The average number of recalls per quarter so far in 2019 is trending to be
Devices
FDA has issued a guidance, Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices, to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a medical device. The document describes the information CDRH and CBER, in collaboration