Drugs
Four Morrison Foerster attorneys say a panel on “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement” held on 11/2 at a Food and Drug Law Institute conference featured a high-ranking attorney from the Department of Justice consumer protection branch and other regulatory compliance leaders to discuss key trends
Devices
The NEST (National Evaluation System for health Technology) Collaborative Community has issued a draft white paper, “Achieving Unique Device Identifiers in Real-World Data Sources: A Playbook for Health System Unique Device Identifier Implementation at the Point of Care.” The paper says it is intended to augment real-world evidence
Devices
FDA and MITRE have updated the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which the two organizations first published in 2018. An agency announcement says the playbook focuses on preparedness and response for medical device cybersecurity issues that affect a medical device’s functionality. MITRE says (includes links
Devices
FDA has announced a 12/7 public workshop on “Appropriate Use of Consensus Standards” to obtain public input on using them in premarket submissions for medical devices. The agency also plans to discuss “potential approaches to help facilitate the use of standards in premarket submissions,” according to a notice. Additionally,
Drugs
Amazon Web Services says it supports the intent of an FDA draft guidance on computer software assurance for production and quality system software and makes several recommendations “to strengthen and accelerate the use of technology for quality improvement.” The company recommends: * reissuing the guidance to apply across the entire agency
Devices
AdvaMed says FDA should withdraw its draft guidance on LASIK patient labeling recommendations because the group has numerous concerns about the document. The guidance was issued to help ensure that information is available to patients and healthcare professionals about the benefits and risks of LASIK devices that are used in
Devices
FDA has issued Roche Molecular Systems an emergency use authorization (EUA) for its cobas MPXV monkeypox test. The test, which is intended to be run on the company’s cobas 6800/8800 systems, is authorized for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from
Devices
FDA has cleared a Xironetic 510(k) for its IntraOpVSP augmented reality (AR) visualization software for use in complex surgeries. The device displays patient CT and MRI images as three-dimensional holograms in AR headsets, “helping surgeons visualize surgical plans, anatomical targets, and cutting guides alongside or overlayed on the
Devices
Insulet has announced a Medical Device Correction for the Omnipod 5 Automated Insulin Delivery System because of an issue with the Omnipod 5 Controller charging port and cable. The correction follows 24 reports the company says it received about the Omnipod 5 Controller charging port (USB-C port) or cable
Devices
FDA has cleared a DiaSorin 510(k) for its Simplexa Congenital CMV Direct kit, a molecular diagnostic test that detects cytomegalovirus (CMV) DNA in saliva swab and urine specimens from infants that are 21 days old or younger. Saliva swab specimens are easy to collect for screening purposes and urine
Devices
FDA has published a guidance, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents, to promote clarity regarding references to the terms “device” and “counterfeit device.” The document says the Safeguarding Therapeutics Act redesignated the definition of
Devices
AdvaMed is proposing a change to an FDA draft guidance on ethical considerations for clinical investigations of medical products involving children. The association says that to promote the development of pediatric medical devices, the guidance should include relevant information on when adult data can be extrapolated for pediatric use from
Devices
Bristol Myers Squibb commends FDA for publishing a draft guidance on computer software assurance for production and quality system software, but finds several aspects of it that appear contrary to the agency’s stated objectives or are not fully developed. In a comment letter, BMS says the items needing clarification
Devices
Yale University researchers say that with the role of artificial intelligence (AI) in breast cancer screening likely to grow in the next decade, it is important that FDA increase evidentiary regulatory standards, develop improved postmarketing surveillance and trials, and engage key stakeholders to help ensure that new AI products meet
Devices
FDA says Insulet Corp. announced 10/17 a medical device correction for all Omnipod DASH personal diabetes managers distributed globally. An agency notice says the company had received reports from users about device battery issues, including battery swelling and leakage and, in rare cases, extreme overheating resulting in reports of
Devices
FDA has cleared a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage (ICH) triage and notification product. The company says the latest version improves on its technology that supports physicians’ ability to address intracranial hemorrhagic management more accurately and comprehensively than other available products on
Drugs
The Combination Products Coalition (CPC) says its members have recently experienced FDA requesting that combination product manufacturers demonstrate how they have “validated” device user interface specifications in the intended user population. A CPC statement says its member companies are not aware of any agency guidance or recognized consensus standards that
Devices
Two Wiley Rein attorneys say medical device manufacturers should start now to develop a transition implementation plan and marketing submission to respond to an FDA notice that it will finalize two guidances dealing with the transition of enforcement policies and emergency use authorizations (EUAs) issued as part of the Covid-
Drugs
FDA Office of Combination Products director Thinh Nguyen says seven priority guidances are in the clearance process and should be published in the first quarter of 2023. Speaking at the Combination Products Summit 2022, Nguyen said the guidances address: * human factors for combination products (final guidance); * essential performance requirement: established
Devices
The Medical Device Innovation Consortium (MDIC), of which FDA is a member, has released a new framework that outlines a systematic approach for patient-focused clinical trial designs. The group says the framework, “Using Patient Preference Information in the Design of Clinical Trials,” was developed to help inform researchers interested
Devices
FDA has cleared an Exactech 510(k) for its TriVerse primary knee system. The device is designed to accommodate cruciate retaining, anterior stabilized and posterior stabilized constructs, according to the company. Its insert bearings are made of “highly crosslinked vitamin E-stabilized polyethylene,” it says, adding that it comes with
Devices
FDA has issued a safety alert warning parents and caregivers not to use infant head shaping pillows intended to change an infant’s head shape or symmetry. “The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose,” an agency