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PATHWISE INDUSTRY NEWS

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

JULY 2021 INDUSTRY NEWS

 

MDCG posts guidance on UDI integration within a QMS

“The European Commission’s Medical Device Coordination Group (MDCG) issued new guidance providing recommendations for integrating unique device identification (UDI) processes within a manufacturer’s quality management system (QMS) to meet requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).
The 10-page guidance calls for manufacturers to have a plan for implementing UDI, as assignment of UDI-DI and management of UDI-related processes “can impact many other lifecycle QMS processes.”

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FDA

FDA Under Pressure to Restore “Normal” Drug Inspections

“Congressional leaders, as well as regulated industry, want more information from FDA on its strategy for resuming inspections of manufacturing facilities to better assure the quality, safety and efficacy of medical products. The suspension of in-person field inspections in March 2020 has resulted in a huge backlog of delayed site visits, as FDA sent investigators only to those operations deemed “mission critical.”

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Investigations​FDA’s regulatory affairs head previews Inspectional Affairs Council

“The top regulatory affairs official at the US Food and Drug Administration (FDA) gave a preview of a soon-to-be-launched council within the agency that will focus solely on inspection-related matters. We will soon stand up an agency-wide decision-making body; it’s called the FDA Inspectional Affairs Council,” said Judith McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA), speaking at a virtual webinar hosted Wednesday by the Alliance for a Stronger FDA.”

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Secure by Design: Developing Cybersecure Medical Devices

“Medical devices are becoming increasingly connected to other devices, the Internet, or hospital networks to serve functions that improve healthcare and enhance treatment options. According to estimates, one in four medical devices is already connected to the Internet or hospital network. In 2017, they totalled an estimated 337 million, with an expected compound annual growth rate (CAGR) of 20.8% through 2030—including digital health apps. Their development is driven by the German Digital Healthcare Act (DVG) and similar initiatives across Europe. 1 Digital health apps are playing increasingly important roles in healthcare with approximately 200 new health apps being added to the app stores every day. “

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JUNE 2021 INDUSTRY NEWS

Report shows Western European medical device market recovering post-COVID

“According to a recent report by international growth partnership company Frost and Sullivan, Western Europe’s medical device market is on track to recover from the COVID-19 pandemic by 2023. The report, titled ‘Impact of COVID-19 on Elective Procedures in Western Europe, 2020–2023’, projects that the market for selective medical devices for elective procedures will reach $16.8 billion (€13.76B) by 2023. according to an aspirational compound annual growth rate of 29.2%. Because of COVID-19, there was a 45.5% decline in the selective medical devices market for elective procedures from the pre-COVID projections for 2020. However, the restrictions and challenges raised by the pandemic have forced medical device manufacturers to think in new ways, creating growth opportunities in the sector.”

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FDA
FDA lays out device cybersecurity efforts

“Kevin Fu, acting director of medical device cybersecurity at the FDA’s Center for Devices and Radiological Health, warned last month that cyber threats to the healthcare and medtech industries, including ransomware and other malware, are growing in sophistication potentially putting patient safety at risk. “Everything is hackable,” Fu told the Food & Drug Law Institute annual conference in May, noting that medical devices infected by ransomware can be disabled from properly performing critical clinical functions, which could lead to patient harm.”

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Man looking at machine with clipboard

FDA explains when device ‘servicing’ becomes ‘remanufacturing’

“At what point does manipulation or repair of a medical device cross the line from “servicing” to “remanufacturing?” A new draft guidance from the US Food and Drug Administration (FDA) provides a set of considerations to aid in determining into which category actions performed on devices should fall. The new draft guidance “helps clarify whether activities performed on devices are likely remanufacturing,” wrote FDA’s Center for Devices and Radiological Health (CDRH) in announcing its availability. The guidance is intended to clarify, rather than to change, the regulatory requirements to which remanufacturers must adhere. “It is not intended to adopt significant policy changes,” according to CDRH.”

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FDA Advisory Committees Under Scrutiny

“FDA is looking for greater consistency and fewer surprises in discussions by and decisions from its cadre of expert, independent advisory committees. These panels are formed to provide scientific and medical expertise to help shape FDA decisions in all regulatory areas, most notably to evaluate, approve, or reject applications for new drugs, biologics, and medical products. To gain a more efficient and transparent advisory system, the Center for Drug Evaluation and Research (CDER) has launched an initiative to gain more efficient and transparent operations of its advisory panels, says CDER director Patrizia Cavazzoni.”

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MAY 2021 INDUSTRY NEWS

MDR’s Day One: Experts weigh in

“In the EU, the day has come. On Wednesday, the European Commission applied the updated suite of regulations known as the Medical Devices Regulation (MDR). The 26 May 2021 date comes a year later than the originally planned date of application of new regulations for EU’s medical devices industry, to work around disruptions caused by the COVID-19 pandemic. The European Commission (EC) issued a question-and-answer document Wednesday announcing the application of MDR; the document notes that some MDR provisions will not be in place until 2025, to smooth the transition.”

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FDAFDA Inspection “Roadmap” Acknowledges Continued Delays & Challenges Ahead

“Efforts to return to a more consistent and timely federal field inspection program will take considerable time, as FDA expects to conduct only a small portion of scheduled facility visits this year due to continued limitations on travel imposed by the COVID-19 pandemic. With a huge backlog built up since March 2020, it’s not clear when the agency’s inspection program for drugs and medical products will fully recover. These challenges are acknowledged in the recently issued “Resiliency Roadmap for FDA Inspectional Oversight,” which details how the pandemic has delayed all but the most important “mission critical” and high priority inspections this past year, leaving thousands of site visits that will need attention in the coming months — and years.”

]READ THE FULL ARTICLE HERE

pharmaceutical

FDA In Brief: FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products

“The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonization of requirements for drug lifecycle management, manufacturers and the FDA can meet these goals in less time through effective management of postapproval changes. To help provide a more predictable and efficient approach to management of postapproval changes, today we’re announcing a final guidance for industry with new International Council for Harmonisation (ICH) guidelines.”

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EU plans to impose additional regulations on medtech AI products, other ‘high risk’ systems

The European Union is advancing artificial intelligence regulations that could impact medical device and diagnostic companies around the world. Through the policy, the EU plans to impose additional requirements on the use of AI in medtech and issue fines for noncompliance that could total billions of dollars. In a document setting out its plans, the European Commission states high-risk AI systems should only be placed on the EU market “if they comply with certain mandatory requirements” that ensure they do not pose unacceptable risks to important public interests. Medical devices and in vitro diagnostics are on a long list of products that could be classed as high-risk.”

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Petri DishCMOs should invest in biologic API manufacturing capabilities, says GlobalData

“New research suggests that contract manufacturing organisations (CMOs) should invest in capabilities and expertise to produce active pharmaceutical ingredients (APIs) for sensitive biologics and handle end products. According to GlobalData, this is an important opportunity for CMOs, since the complexity and number of pipeline and approved biologics continues to increase. The company stated that the US Food and Drug Administration (FDA) approved more biologic new molecular entities (NMEs) in 2020 than in any other year in the last decade. Additionally, and with particular emphasis on COVID-19 vaccines, sponsors increased the outsourcing of these biologics’ API manufacturing. The enterprise added that, mega and large cap companies sponsored 52 percent of the biologic NMEs approved by the FDA in 2020.”

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APRIL 2021 INDUSTRY NEWS

UCLA engineer calls for mitigation of biases of medical devices

“The industry and regulators are aware of the risk of bias in several respects. Last year, FDA and Philips warned that social biases in the data used to train artificial intelligence and machine learning systems could negatively impact patient care. FDA is also reviewing how skin pigmentation affects the results of pulse oximeters, after a New England Journal of Medicine analysis revived long-running concerns in reporting that “Black patients had nearly three times the frequency of occult hypoxemia that was not detected by pulse oximetry as White patients.”

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EU MDR delay has not made new rules easier to stomach: exec poll

“The survey comes nearly one year after the delayed implementation of the MDR as Europe and industry were dealing with the challenges of the coronavirus pandemic. Even with the delay, concerns abound over the effects the pandemic is causing as the implementation deadline approaches, such as the lack of in-person audits and countries’ differing opinions around virtual audits.The MDR is now scheduled to take effect May 26.”

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10 Actions To Prepare For The U.K. Conformity Assessment Process

“As medical device businesses work on complying with the EU’s Medical Device Regulation and In Vitro Diagnostic Regulation, they must now also turn their attention to changing regulatory rules in the U.K. The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA), including CE marked and U.K. Conformity Assessed (UKCA) marked devices, though there are grace periods for this initial registration based on the risk classification of a device.”

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The Draft Principles of ICH E6 Good Clinical Practice (GCP) now available

“The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients. Acknowledging the wide and substantial impact of ICH E6, the ICH Management Committee is making available a draft, work-in-progress version of the updated principles that are currently under development by the ICH E6(R3) Expert Working Group (EWG). The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials.”

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EU assessment of high-risk medical devices faces in-depth review

“The methods for evaluating high-risk medical devices are set to be reviewed in the EU-funded CORE-MD project, which holds its kick-off meeting today. The project launch comes as new EU medical device regulations come into force on 26 May 2021, increasing the requirements for clinical evidence on high-risk medical devices. However, there are no specific EU recommendations on the design and conduct of trials for high-risk devices. In addition, medical device developers have expressed concerns that the new rules may inhibit innovation and delay market access. More than 50% of high-risk implantable medical devices in Europe are used in cardiology and orthopaedics – such as heart valves and hip replacements – and CORE-MD will focus primarily on these areas. The three-year project begins with a systematic review of methodologies used in clinical trials to evaluate high-risk medical devices, including statistical methods and the utility of patient-reported outcomes for regulatory decisions.”

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