Dive Brief The Food and Drug Administration published final guidance on the remanufacturing of medical devices on Thursday. Acting on feedback from groups including Advamed, the FDA has changed the title of the text and added a section on the regulatory requirements for remanufacturers. The new section, which applies to original equipment manufacturers and service providers, is intended to help entities that are less familiar with the medical device regulatory requirements. Dive Insight The FDA published draft guidance in 2021 to clarify the distinction between device remanufacturing and servicing. Many reusable medical devices are serviced. Previously, it was unclear when servicing became so extensive that it qualified as remanufacturing. The draft defined remanufacturing as an act done to a finished device that significantly changes the performance, safety or intended use, including renovating, repackaging or restoring products. After assessing feedback on the draft, the FDA has retained its definition of remanufacturing ...
Drugdu.com expert’s response: The U.S. FDACFR21 regulations refer to Title 21 of the Code of Federal Regulations (CFR), which encompasses regulations established under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This set of regulations, overseen by the U.S. Food and Drug Administration (FDA), governs various aspects of the production, distribution, labeling, advertising, and safety of food, drugs, medical devices, cosmetics, and other related products. CFR Title 21 includes provisions covering: 1.Drug Quality and Manufacturing Practices: Regulations concerning quality control, processes, equipment, raw materials, packaging, and other aspects of drug manufacturing. 2.Food Labeling and Ingredients: Requirements for information on food labels, ingredient lists, nutrition labeling, etc., ensuring consumers receive accurate information. 3.Medical Device Registration and Reporting: Mandates for medical device manufacturers to register and report, as well as comply with relevant quality management system requirements. 4.Cosmetic Safety and Labeling: Standards for cosmetic safety, ingredient restrictions, and labeling requirements to ...
Ray Kingman The industry must find a way to balance consumer privacy and a return on investment in pharma marketing. Promoting advances in pharmaceuticals is full of challenges. From recruiting clinical trial participants, to engaging patients with their permission at the point of care, to creating brand lift and awareness, the marketing landscape for pharma presents both logistical and regulatory obstacles when it comes to constructing and executing a successful marketing program. Identity, and how it is managed, presents special challenges for audience targeting and especially measurement of campaign performance in an evolving identity resolution environment. Across our multi-channel, multi-platform and multi-media landscape the signals that avail us for targeting and measurement are often impeded by the requirement to block or exercise restraint when it comes to sensitive data and patient privacy rights. Building privacy-compliant audiences for pharma campaigns takes special care, but identifying audience engagement that measures campaign outcomes ...
Organiser: MINISTRY OF HEALTH Time:9 – 12 May 2024 address:91 Tran Hung Dao St. ,Hoàn Kiêm, Hanoi, Vietnam Exhibition hall: Cultural Friendship Palace Product range: Medical products: medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic medical equipment and supplies, ENT equipment, dental products and supplies, medical health products and equipment, medical institutions and laboratory technical equipment, medical information and technical exchange, beauty equipment, etc Pharmaceutical equipment: pharmaceutical production equipment and technology, pharmaceutical packaging equipment, pharmaceutical packaging materials, pharmaceutical production, cleaning and disinfection configuration system, etc Laboratory equipment: optical instrument equipment, microscope, optical image processing, electronic measuring instrument, multimeter, electronic probe, electronic simulation system, single-chip microcomputer development system, image analysis and processing system, etc Analytical instruments: optical analytical instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, various portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other ...
The BCR::ABL1 fusion gene plays a key role in the pathogenesis of several blood cancers, particularly chronic myeloid leukemia (CML). This gene results from a chromosomal translocation that causes constitutive activation of the ABL1 tyrosine kinase domain, triggering unchecked cell growth. Testing for the BCR::ABL1 fusion gene is crucial in managing leukemia, as it helps identify patients with Philadelphia chromosome-positive leukemia who might benefit from targeted therapies such as tyrosine kinase inhibitors (TKIs). While Sanger sequencing has been the standard method for this analysis, it has its limitations in sensitivity. Next-generation sequencing (NGS) offers a more comprehensive approach to detecting, quantifying, and analyzing the genetic alterations associated with leukemia, including minor BCR::ABL1 transcripts and mutations. NGS thus provides detailed insights into disease progression, treatment response, and potential resistance mutations, enabling personalized treatment plans. BioVendor MDx (Brno, Czech Republic) has introduced the first commercial NGS assay specifically for the BCR::ABL1 fusion ...
Nova Laboratories’ Xromi (hydroxycarbamide) has received approval from the Medicines and Healthcare products Regulatory Agency and the European Commission to extend the indication for vaso-occlusive complications of sickle cell disease (SCD) to infants from nine months of age. SCD is a group of inherited red blood cell disorders that are caused by a genetic mutation that affects the production of haemoglobin, the protein in red blood cells that carries oxygen. The regulatory decisions were based on data from the pharmacokinetic, efficacy and safety study, HUPK, which showed that Xromi is expected to work in the same way in children from nine months of age as it does in older children. Furthermore, additional data from the phase 3 BABY HUG study suggests that the benefits and safety of Xromi in children as young as nine months of age are similar to those in older children. Dr James White, deputy managing director, ...
PharmaLink has partnered with Recall Results on an accurate and responsive process for drug recalls, withdrawals and market actions in the pharmaceutical industry. The collaboration combines PharmaLink’s pharmaceutical returns processing expertise with Recall Results’ knowledge and advanced technologies for managing complex recalls.It will focus on the development of integrated systems to streamline the process of recalls, supporting recalls of any class to the patient level. It aims to cut down the time to identify and respond to potentially harmful pharma products in the market.With a focus on patient safety and compliance, the two companies are set to establish new standards in recall management. PharmaLink CEO Thierry Beckers stated: “Through this partnership, PharmaLink offers comprehensive services for the notification, product retrieval, processing, storage and disposal of recalled products from the healthcare supply chain.“We could not be more excited about the launch of this strategic partnership and the solutions it brings to ...
BY SEAN WHOOLEY The ClearPoint Prism neuro laser therapy system. [Image courtesy of ClearPoint Neuro] ClearPoint Neuro (Nasdaq:CLPT) announced today that the FDA granted 510(k) clearance for its Prism bone anchor accessory. It marks the second new product introduction in 2024 for the company, with its stereotactic guidance system garnering clearance in January. The Prism system features the only non-cooled laser applicator on the market, the company said. Its next-generation laser applicator technology eliminates the need for external cooling. This simplifies setup, reduces power and ablation time and lessens imaging artifact for more efficient workflows. ClearPoint Neuro designed its Prism bone anchor accessory for use with commercially available stereotactic systems. These systems work for intracranial and neurosurgical procedures. Such procedures require accurate positioning of compatible small surgical instruments or accessories in the cranium, brain or nervous systems. The anchor provides short-term fixation and positioning of those instruments or accessories under image guidance. Chris Osswald, director, ...
Blood drawing is performed billions of times each year worldwide, playing a critical role in diagnostic procedures. Despite its importance, clinical laboratories are dealing with significant staff shortages, which impact their ability to deliver timely test results and maintain satisfactory patient care. Now, an innovative robotic blood drawing device for the medical laboratory market could help ease staff workload and provide a more consistent patient experience. Developed by Vitestro (Utrecht, The Netherlands), this innovative blood-drawing device is designed to perform safe and accurate blood draws. It utilizes artificial intelligence (AI) for ultrasound-guided 3D reconstruction and ensures submillimeter precision in needle insertion. This high level of accuracy and consistency in blood collection is achieved through a combination of AI, advanced imaging technologies, and robotics. By automating blood draws, Vitestro’s device not only reduces the physical demand on staff but also enhances the satisfaction of both patients and healthcare providers. The ...
Attended by 200+ delegates with 13 case-presenters who drove 8.5 hours of scientific discussions each day, the end-objective of the Summit was to discuss best domestic and international practices in order to drive better patient care in venous domain in India To create awareness and enable knowledge-sharing around Venous diseases, in order to drive better patient care, BD (Becton, Dickinson, and Company) conducted roadshows across New Delhi, Mumbai and Bangalore recently. Venous disease is a condition where the veins in the body have difficulty returning blood to the heart, thereby resulting in blood clot forming in a vein, typically in the legs. If left untreated, these clots can break loose and travel to the lungs, causing serious complications. Delayed detection and intervention can lead to worsened clinical outcomes and a multitude of problems for both patients and healthcare professionals. The 3-day Venous Summit witnessed a series of Technology Innovation Forums ...
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