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PATHWISE INDUSTRY NEWS

Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 

AUGUST 2020 INDUSTRY NEWS

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

“The availability of notified bodies designated under MDR has remained a worry despite the decision to delay implementation of the regulation until next year. Travel restrictions imposed to curb the spread of COVID-19 stopped notified bodies from performing on-site audits of device manufacturers, leading MedTech Europe to call for authorities to permit remote assessments for incoming regulations. DQS has been taking advantage of the option to perform remote audits under the existing Medical Device Directive. The remote audits enabled the notified body to maintain device certifications while the German government had travel warnings in place.”

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Petri Dish

CBER Takes On More Oversight Of Biologic & Biosimilar Master Files

“The Drug Master File (DMF) is one of the most effective ways for companies to protect proprietary information while still collaborating with partners. A DMF is a snapshot of the manufacturing process that is submitted to the FDA to review the suitability of a drug for clinical trials (INDs) or commercialization (NDAs or BLAs). When a DMF is submitted to the FDA, its contents are confidential. The proprietary information may only be cross-referenced — not accessed — by a partner. Under this model, the company that cross-references another company’s DMF is not expected to understand and/or be able to defend the partner’s process and process controls. This year saw a significant change in the process for submitting master files for biologic products: as of March 23, 2020, biologic-related master files are now administered by the FDA’s Center for Biologics Evaluation and Research (CBER).”

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MDCG explains how notified bodies can use MDSAP audit reports

“In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR). While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used to inform the scope and focus of surveillance audits performed by notified bodies. It is important to stress that the MDR/IVDR remain applicable in their entirety. The use of MDSAP audit reports within the EU legislative framework is possible only where the MDSAP audit covers similar or equivalent MDR/IVDR requirements,” MDCG writes.”

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FDA

FDA delays collecting drugmaker data required by CARES Act

“The FDA said this week that it won’t begin collecting new data required from drugmakers under the Coronavirus Aid, Relief, and Economic Security Act next month, though the measure is set to take effect Sept. 23, Regulatory Focus reported. Though the rule is set to take effect next month, the FDA says the electronic data submission portal it’s developing for drugmakers to submit the information won’t be ready by then. FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information. We will provide further updates as our implementation planning continues,” the FDA said.”

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COVID-19 Medical Device Shortages and What the Industry Is Doing About It

“Medtech has really stepped up this year to respond to medical device shortages brought on by the COVID-19 pandemic. Despite these impressive efforts, there remains a growing list of medical device shortages. FDA maintains a publicly-available, up-to-date list of the medical device shortages tied to the pandemic. This list is part of FDA’s obligation under the CARES Act, which was signed into law on March 27. Of the 20 products that FDA listed on Friday, eight are categorized as testing supplies and equipment, nine are considered personal protective equipment, and three are ventilation-related products.”

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JULY 2020 INDUSTRY NEWS

New online store aims to accelerate the medical device development process

“The company specialises in the interventional and radiology markets, and this new e-commerce platform will sell a range of off-the-shelf nylon, PET, and LDPE medical balloons. The store will aim to enable engineers to develop and prototype next-generation catheters quickly. Chris Richardson, director of business development at Biomerics FMI, said: “We have been manufacturing first-in-class balloons for over 25 years. Biomerics currently manufactures over 20,000 balloons per week that are sold as components or further processed into finished medical devices.”

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Updates on MDR implementation, transparency; MDCG posts CEAR template

“The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation. The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medical devices undergoing conformity assessments.

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Impact of COVID-19 emergency on US FDA interactions with medical device manufacturers

“The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. New guidance from FDA explains the regulator’s approach to conducting premarket medical device reviews, adjusting user fees and consulting with manufacturers during the COVID-19 crisis. Given FDA’s ongoing work on Emergency Use Authorizations (EUAs) for ventilators, IVD test kits and other medical equipment in high demand, the guidance states that some performance goals and user fee commitments established under MDUFA IV may be missed or delayed. Furthermore, US medical device market registrants should expect greater use of video- and teleconferencing when meeting with FDA officials for 510(k) premarket notifications, Premarket Approvals (PMA) or Q-Submission consultations.”

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FDA

FDA Announces Plans to Resume Domestic On-site Inspections

“On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20.  The Agency has developed a “COVID-19 Advisory Level” risk-based rating system to help assess where inspections may safely resume.  Under the rating system, facilities in areas where cases of COVID-19 are under control can expect to be inspected sooner than facilities in areas where COVID-19 cases are on the rise.

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Liability Issues Continue to Evolve in Computer-Assisted Surgery

“Device manufacturers of CAS systems should keep abreast of the changing legal issues. Computer-assisted surgery (CAS) is rapidly growing as a treatment option in orthopaedics, especially for total joint replacement surgeries. Although CAS has the potential to improve the accuracy of component alignment and implant positioning, recent peer-reviewed medical journal articles explore whether the technology is more effective than traditional surgical methods. This article addresses the legal implications of these articles for manufacturers of CAS systems, which FDA has recognized as an important new treatment option.

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JUNE 2020 INDUSTRY NEWS

Children with ADHD can now be prescribed a video game, FDA says

“The first video game-based treatment for attention deficit hyperactivity disorder (ADHD) has been approved by the US Food and Drug Administration (FDA).The video game, called EndeavorRx and approved on Monday, will be prescription only and aimed at children between the ages of eight and 12 with certain types of ADHD. It will be used alongside other treatments, such as clinician-directed therapy, medication and educational programs. ADHD is a common neurodevelopmental disorder which is usually first diagnosed in children and can last into adulthood.

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Human Factors Engineering (HFE) During the COVID-19 Pandemic

There has been a lot of speculation, and also pessimism to some extent, regarding the implementation of Human Factors Engineering (HFE) into the design of medical devices and combination products in the current COVID-19 pandemic. This is not surprising given the challenges the situation has posed—travel restrictions, social distancing, government and local regulations and guidelines, and above all, the risk of contracting and transmitting the disease for which there is currently no definitive treatment or vaccine.”

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How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis

“The COVID-19 pandemic has disrupted clinical trials globally and has resulted in a 65% worldwide decrease in new patient enrollment year-over-year during March 2020. As a result, regulators across the globe have issued new guidances to support the industry in their hour of need. The US Food and Drug Administration (FDA) has launched a special emergency program for possible therapies for COVID-19 – the Coronavirus Treatment Acceleration Program (CTAP), which combines elements of multiple existing review pathways. “

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FDA

Hahn: Permanently adopting R&D-accelerating COVID-19 measures is a top FDA priority

“FDA Commissioner Stephen Hahn, M.D., has vowed to permanently adopt COVID-19-driven changes that make reviews and authorizations faster. Hahn made the commitment in a speech that called on the FDA to learn from the crisis to enact lasting policies that accelerate drug development. Fresh from a 14-day quarantine necessitated by contact with someone infected with COVID-19, Hahn set out how the FDA responded to the crisis and how it will shape the future of the agency. While acknowledging that the FDA’s response to the pandemic encountered some “hiccups,” Hahn sees positives that support the accelerated transformation of the agency under his leadership.

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MAY 2020 INDUSTRY NEWS

FDAFDA plans phased approach to restarting surveillance inspections

“After halting most foreign and domestic inspections in March due to the coronavirus disease (COVID-19) outbreak, the US Food and Drug Administration on Monday said it is working with the Centers for Disease Control and Prevention (CDC) on a phased plan for resuming on-site surveillance inspections. In March, FDA said it would halt foreign inspections and domestic routine surveillance inspections and would only conduct “mission-critical” foreign or domestic for-cause  inspections. In lieu of on-site inspections, the agency said it would resort to alternative means of oversight, such as evaluating records from facilities. “

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Eudamed update: Phased implementation planned for European medical device, IVD database

The implementation of the European Database for Medical Devices, Eudamed, has been delayed by two years and the implementation of the Medical Devices Regulation (MDR) has been delayed by one year. The European Commission has informed Emergo that parts of Eudamed will be made available to users before the official Eudamed date of application in May 2022. In this way it becomes possible for economic operators to start using Eudamed before they are legally required to do so. This will help companies to prepare and will also help the authorities to smooth out unforeseen issues before the date of application.”

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In the Race Towards a Vaccine, Manufacturing and QC Must Keep Pace

“The COVID-19 pandemic is “an unprecedented crisis, and we’ve never seen anything like it,” Pat Shafer, managing director in Grant Thornton‘s healthcare and life sciences industry business, told MD+DI recently. Judging from the amount of stories MD+DI has published alone in the last several weeks on the rapid responses from many medical device and diagnostics companies as well as industry suppliers, manufacturers are working quickly toward several potential solutions. The medical device industry has been very agile in responding to the pandemic, Shafer said. “Most manufacturing has not had any production stoppages, and factories are still open, and many have sufficient supplies on hand.”

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Coronavirus vaccine developers plan to enroll tens of thousands in late-stage tests

“Coronavirus vaccine developers, working against the clock to quickly prove their experimental candidates, are preparing for late-stage clinical trials that would enroll tens of thousands of people in the U.S., Europe and, potentially, other regions as the pandemic’s heaviest impact begins to shift to the Southern Hemisphere. So far, early safety studies of coronavirus vaccines have involved several dozens to hundreds of healthy volunteers. But establishing the safety and effectiveness of a treatment that could potentially be given to tens of millions of people globally will require massive trials spanning many countries.”

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