Devices
CDRH is proposing 18 guidances to be published this fiscal year, with 11 on the Center’s A-list of prioritized guidances and seven on the B-list of guidances to be published as resources permit. An online statement lists the A-list final guidance topics as: * remanufacturing of medical
Devices
Rep. Rosa DeLauro (D-CT) says she has been informed by FDA that a new breast density notification rule is to be published by the end of 2022 or early in 2023. The rule would require that mammography reports to women and their healthcare providers notify patients if they have
Devices
Medtronic has announced that a backup controller with modified software can be used if the primary controller fails to restart its HeartWare Ventricular Assist Device system. An agency notice says that the company 6/2021 stopped selling and distributing the device based on an increased risk of mortality and neurological
Devices
The recent user fee reauthorization was a “profound missed opportunity” to reform FDA regulatory approaches on diagnostic devices, dietary supplements and cosmetics, according to former FDA commissioners Mark McClellan and Scott Gottlieb. Writing in an online JAMA Forum 10/13, they say lawmakers missed a “once-in-a-generation” chance
Devices
FDA has cleared an Ulrich Medical 510(k) for its Flux-C 3D-printed porous titanium cervical interbody device. The product features “superior endplate contact and spaces for generous inter-device bone grafting,” the company says. It is manufactured using a 3D printing process called direct metal laser sintering. “The
Devices
Two Centers for Medicare and Medicaid Services (CMS) officials say the center continues to work with FDA and other stakeholders on a new coverage rule for innovative medical devices. The new rule will replace one withdrawn by CMS after doctors and others raised concerns that the policy did not have
Devices
Jiangsu Well Biotech (Jiang Su Sheng, China) has recalled its Covid-19 Ag Rapid Test Devices because they were distributed without authorization, clearance, or approval from FDA. The company has not provided the agency with validation data to demonstrate the test’s performance is accurate, which could contribute to potential
Devices
FDA says CDRH has launched its Total Product Life Cycle Advisory Program (TAP) pilot intended to “de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid
Devices
FDA has extended by one month to 11/25 the deadline for comments on its draft guidance intended to help ensure that information is available to patients and healthcare professionals about the benefits and risks of LASIK devices that are used in vision correction. The Broken Eyes patient group tells
Devices
Three Hyman, Phelps & McNamara attorneys and the firm’s medical device regulatory expert say the FDA 9/28 final Clinical Decision Support (CDS) Software Guidance “represents a marked change in approach from prior drafts and foreseeably will result in the regulation of many types of CDS that were previously
Devices
Zeiss Medical Technology has gained 510(k) clearance for MTLawton, disposable bipolar forceps made from a copper-base alloy that potentially reduce tissue adhesion and subsequent charring during dissection of tissue. Zeiss Medical says the forceps also feature an extended shaft to reduce visual restrictions in the surgical field. and
Devices
FDA has cleared a Copan Diagnostics 510(k) for its Colibrí, a semi-automated pre-analytical processor that is part of the company’s WASPLab laboratory automation system. The in vitro automated specimen workup platform is designed to prepare tests for antibiotic susceptibility testing. It comprises the Colibrí Vision System
Devices
FDA has issued Abbott Molecular an emergency use authorization for its Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. This is the first commercial test kit to be authorized for detection
Devices
Fresenius Kabi has recalled its Ivenix Infusion System’s large volume pump software due to a software design issue. A recall notice says the display screen may become “frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a
Devices
FDA has cleared a Boston Cell Standards 510(k) for its IHControls panel (HER2/ER/PR) for evaluating breast cancers. IHControls is intended to ensure that all immunohistochemistry (IHC) tests, on all patient samples, are performed correctly, according to the company. “Any variation in the IHC reagents, instrument, or protocol
Devices
FDA says it has changed the status of the Bayer Essure postmarket surveillance study to “progress inadequate.” A 10/6 Essure information update says the status change for the birth control device study is due to the increase in interim lost to follow-up rates in both the Essure and
Devices
Federal Register notice: FDA has announced the medical device user fee rates and payment procedures for fiscal year 2023. For example, here are some of the more common standard fee rates: * PMA/BLA/PDP: $441,547 * Efficacy (BLA) supplement: $441,547 * Panel-track supplement: $353,238 * De novo classification request:
Devices
FDA has cleared an Aurora Spine 510(k) for its SiLO TFX MIS Sacroiliac Joint Fixation System. The device is intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, according to the company. Comprising a transfixing-cone, an ilium screw, a sacrum screw and associated instrumentation, the device is
Devices
FDA has approved a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Roche says HER2 is
Biologics
CBER has published four Standard Operating Policies and Procedures (SOPPs) relating to the administrative processing of applications. SOPP 8401: Administrative Processing of Original BLAs and NDAs includes those subject to the Biosimilar User Fee Act (BsUFA) and Prescription Drug User Fee Act (PDUFA). It does not apply to BLAs subject
Devices
FDA and researchers from New York University are partnering to design a regulatory science tool (RST) based on data from biomarkers to improve the review processes for stroke rehabilitation devices and determine how best to use them. While there is a growing market of such devices, recommendations for how and
Devices
An 11/16/21-1/19/22 FDA inspection at Flawless Beauty and Skin, Ocean, NJ, determined that the firm is an initial importer of several Relumins products. A just-released 8/5 Warning Letter says the products are all legally considered to be medical devices that are intended for