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



MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

“The MDCG has released a guidance document concerning the Clinical Evaluation of Orphan Medical Devices. As defined in the guidance document, for a device to be considered an orphan device, it must be a medical device that is specifically intended to benefit patients in the treatment, diagnosis and prevention of a disease that presents in not more than 12,000 individuals per year in the EU…The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased need for pre-market clinical investigations for certain higher risk devices to verify their safety and clinical performance. As one can imagine, this increased requirement to provide more clinical evidence can present many challenges for devices that are specifically intended to be used in rare medical conditions.”


Interviewing Skills

New MSU study finds systematic biases at play in clinical trials

“Randomized controlled trials, or RCTs, are believed to be the best way to study the safety and efficacy of new treatments in clinical research. However, a recent study from Michigan State University found that people of color and white women are significantly underrepresented in RCTs due to systematic biases. The study, published in the Journal of Ethnicity in Substance Abuse, reviewed 18 RCTs conducted over the last 15 years that tested treatments for post-traumatic stress and alcohol use disorder. The researchers found that despite women having double the rates of post-traumatic stress and alcohol use disorder than men, and people of color having worse chronicity than white people, most participants were white (59.5%) and male (about 78%).”


Experts advise against prescriptive FDA policies for regulating AI

“Experts said that any future framework for regulating artificial intelligence (AI) by the US Food and Drug Administration (FDA) should avoid being overly prescriptive. They also urged greater collaboration between industry partners for developing best practices for using AI. Pharmaceutical and medical device industries need to be very specific in what they hope to achieve with AI, said experts at the RAPS Regulatory Intelligence Conference on 7 June. The panel was moderated by Chris Whalley, director, regulatory intelligence at Pfizer, and featured commentary from Bradley Thompson, RAC, who leads Epstein, Becker & Green’s AI practice, Sam Kay, vice president for pharmaceuticals at Basil Systems, Gopal Abbineni, director of regulatory strategy for medical devices at Bayer, Elizabeth Rosenkrands Lange, senior director and head of US global regulatory for EMD Serono/Merck.”


Assessing Industry Impact of FDA’s LDT Final Rule

“As laboratory developed tests (LDTs) have become more advanced and complex, their safety and effectiveness have also generated increased FDA scrutiny. This spring, agency officials took the bold step of identifying LDTs as regulated medical devices, planting the seeds that discretionary treatment and lack of expectations when meeting pre-market or post-market regulatory requirements that has been granted for years, is coming to an end. In a final rule that was issued April 29, FDA announced that an amendment to its regulations now stipulates that in vitro diagnostics (IVDs) are considered devices under the Federal Food, Drug, and Cosmetic Act (FDCA), including instances in which the manufacturer of an IVD is a laboratory.”




Neuralink gets FDA approval to implant chip into second patient

“Elon Musk’s human tech startup Neuralink has received the green light from the U.S. Food and Drug Administration to implant a brain chip into a second patient after it proposed to fix a problem that occurred with the first patient. Earlier this month, Neuralink reported that the first chip implanted into a human’s brain malfunctioned after several threads recording neural activity retracted from the brain. The threads retracted in the weeks following the surgery in late January that placed the Neuralink hardware in 29-year-old Noland Arbaugh’s brain, the company said.”


Artificial Intelligence and Machine Learning Through the Eyes of the FDA

“One of the points that came up that I thought was interesting was FDA’s experience with submissions that include AI and machine learning components. What I described was that since 2016, we’ve received over 300 submissions with AI and machine learning components across different stages of drug development, with the vast majority being in clinical research. The other topic that came up was FDA’s role in enabling this technology across the spectrum. We also discussed the fact that a lot of AI is being used in drug discovery, whether you’re predicting a molecule that could be a target for a clinical trial or the folding of a protein. This is generally outside of what FDA would look at, because eventually these therapeutics would enter through clinical testing, which is where the FDA would look at this data.”


FDAFDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts

“The reorganization will enable the FDA to be more efficient, nimble and prepared for the ever-changing and complex industries we regulate, new food and medical product technologies, as well as the impacts of globalization, climate change and other factors that require the agency to quickly adapt. “This is a distinctive moment for the FDA. I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall,” said FDA Commissioner Robert M. Califf, M.D. “This reorganization has been a major undertaking for the FDA, and I am proud of what we will be able to accomplish more efficiently and collaboratively to better meet our public health mandate.”


Human Factoring TrainingDevice experts offer tips on handling warning letter, 483 responses

“One of the most common technical questions posed to US Food and Drug Administration (FDA) officials by manufacturers is the agency’s expectation for responding to a Form 483 or warning letter. Many people believe that a company is required to respond to a Form 483 within 15 calendar days, but this isn’t true, Gina Brackett, division 1 director, compliance branch at the Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA) within FDA, told attendees during the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA. “First of all, you’re not required to respond to an FDA 483,” Brackett said. The 15 calendar day deadline for response, she explained, is if the agency is considering a warning letter. “[I]f you want your response included in that warning letter, then you need to respond in the 15 calendar days.”




FDA finalizes much-needed rule to regulate laboratory-developed tests

CSPI applauds the Food and Drug Administration’s final rule regulating laboratory-developed tests (LDTs) published today. LDTs, a subset of in-vitro diagnostic tests, are commonly used by patients and healthcare providers to inform treatment decisions, yet they have operated without regulatory oversight for decades. The final rule addresses a long-standing regulatory gap and safeguards patients from potentially unreliable diagnostic tests. “As the complexity and importance of these tests in healthcare have increased, ensuring their accuracy has become more crucial,” said Dr. Peter Lurie, President of the Center for Science in the Public Interest, who while an Associate Commissioner at FDA in 2015, led a report outlining some of the dangers of unregulated LDTs. “This rule is long overdue and will usher in a new era of accountability and heightened consumer protection.”


FDA launches new clinical trial center to improve innovation, communication

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has launched a new center for internal and external experts to discuss new methods for designing and conducting clinical drug trials, dubbed the Center for Clinical Trial Innovation (C3TI). The center will act as a hub to share lessons learned from its other clinical trial initiatives with the drug development community and is meant to promote clinical trial innovation. “C3TI will be a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct,” said Kevin Bugin, deputy director of operations in the Office of New Drugs (OND) who has been appointed to lead C3TI. “C3TI’s mission is to promote existing and future CDER clinical trial innovation through enhanced communication and collaboration.”


European Parliament Votes in Favor of Amendment Extending MDR, IVDR Timelines

The European Parliament has voted overwhelmingly in favor of an amendment to extend transition timelines for the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).The vote occurred on February 16 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The amendment will enter into force on the date of its publication in the Official Journal of the European Union (OJEU), but first the amendment must be adopted by the European Council (expected by the end of February). Following adoption by the European Council, the formal process of publication in the OJEU may begin, and typically takes up to 30 days.


FDA readies staff, device makers for QMSR

“Now that the Quality Management System Regulation (QMSR) final rule has been published, the US Food and Drug Administration (FDA) is working to implement the transition, both internally and externally. The decision to make the transition from Quality System Regulation (QSR) was easy, Keisha Thomas, director of compliance and quality with the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) in FDA, told attendees during the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA. The task of implementing the transition, however, is “not at all easy,” she said, and involves preparing both agency staff and external stakeholders.



Man looking at machine with clipboard


“Inspections by the U.S. Food and Drug Administration (FDA) are on the rise after the nation has recovered from the Covid-19 pandemic. Domestic inspections showed a drop in 2020 due to state health guidelines around quarantine. The rise has more than doubled within three years of post-pandemic inspections. Figure 1 shows foreign and domestic inspections for all FDA-regulated categories: tobacco, devices, biologics, drugs, food, cosmetics, and veterinary. As inspections rise, organization are divesting their traditional quality departments, leaving major gaps in production operations and increasing risks within the business. Some of those include inadequate product investigation and root cause analysis; effectiveness checks not performed (leading to warning letters); and possible legal ramifications, such as injunctions.”


European Parliament committee adopts proposals to revamp pharma legislation

“The European Parliament’s health committee has voted in favor of proposals to overhaul pharmaceutical legislation, passing a raft of amendments to advance the lawmaking process to the next stage. Tuesday, members of the Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) met to vote on potential amendments to the European Commission’s proposals and on the overall texts. The politicians overwhelmingly voted in favor of changes to the current pharmaceutical directive and for the creation of a new regulation. Around 85% of votes were cast in favor of the proposals. Speaking during the vote, Tiemo Wölken, the ENVI rapporteur for the proposed regulations, said that “when we started this mandate, we didn’t know that we would be in the middle of the biggest health crisis in the European Union and the world so far.” The pandemic shaped Wölken’s goals for the proposal.”


FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

On March 12, the FDA issued the draft guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Which includes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (aka, Premarket Cybersecurity Guidance). FDA is proposing to add a Section VII. to the Premarket Cybersecurity Guidance to address new considerations for cyber devices. The new section identifies the cybersecurity information FDA considers to generally be necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.” The Premarket Cybersecurity Guidance, in its current form, remains the agency’s current thinking until the new draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Premarket Cybersecurity Guidance.”


How Will FDA’s New QMSR Affect Medical Device Companies?

“The idea of harmonizing FDA’s Quality System Regulation (QSR) with global standards is not a new one, said Vincent Cafiso, founder and managing consultant at Practical Compliance Results. He related that, in his opinion, FDA significantly revised 21 CFR Part 820 in 1996, which FDA based on the then current version of ISO 9001. “This actually showed some early signs of FDA’s intention to harmonize with some relevant global standard,” he explained. Meanwhile, ISO was also creating the medical device–specific ISO 13485 standard, based on ISO 9001. “So basically ISO 13485:1996 and the 1996 revision to the QSR started life around the same time and they both have the same parent, which was ISO 9001,” Cafiso said. “Those two ‘children’ have been serving the same purpose, just for different companies depending on where they do business in the world.”



The Future of Industrial AI in Manufacturing: A Manufacturing in 2030 Report

​“The growing role and importance of artificial intelligence in manufacturing cannot be overestimated. This pervasive technology, now coming into its own after many years of development and trial and error, is being incorporated into many technologies involved in the manufacturing process, including semiconductors, software applications and platforms, and communications equipment. It is important for the manufacturing industry to understand how AI may shape how factories and plants are run in the years ahead, how it will influence workforce strategies, what business benefits may attend the use of AI and what challenges must be faced and overcome to realize the potential of this technology. At the highest level, a global competition for AI dominance is underway, with manufacturing as a key player in the race. ”


FDA to transition to electronic export documents for devices in 2024

“​Starting next year, the US Food and Drug Administration (FDA) will transition key export documents for medical devices from paper to digital format to reduce paperwork and streamline their workflow. Starting 2 January 2024, export documents for human medical devices that are regulated by the Center for Devices and Radiological Health (CDRH) will be issued electronically by FDA as downloadable PDFs from CDRH’s Export Certification Application and Tracking System (CECATS). The agency says the documents may then be validated by foreign governments and other entities who use the FDA Unified Registration and Listing Systems (FURLS) Export Certificate Validator (FECV) database. Companies can access the FECV online database from a web address or a QR code on the certificate.”


medical device

In vitro diagnostic device regulation in Europe: Update on revisions

“The transition from complying with the EU IVDD 98/79/EC to meeting the requirements of the new EU IVDR 2017/746 involves a substantial regulatory framework for in vitro diagnostic (IVD) medical devices to ensure their safety and quality. The enhanced regulatory framework to speed up the market release includes, but is not limited to, additional scrutiny by a notified body, risk classification and conformity assessment, vigilance and market surveillance, and performance evaluation and performance studies.”



Under a new law, FDA submissions must prove that medical devices meet cybersecurity standards

Already this year, major medtech makers including BDInsulet and Zoll Medical have all alerted their customers to cybersecurity vulnerabilities in their medical devices that could potentially compromise sensitive health information or other personal data. Hoping to prevent any such breaches is the FDA, which will now require medical device makers to submit information about their cybersecurity efforts alongside applications for regulatory clearance of their devices. The new requirements went live Wednesday, as a $1.7 trillion federal omnibus spending bill took effect, though the FDA said in an accompanying guidance that it doesn’t intend to begin enforcing them until Oct. 1, at which point device makers will “have had sufficient time” to adjust to the guidelines.


Combination Products Guidance

MDR transition delay approved by European Parliament and Council

“The European Parliament and Council today voted to approve a Medical Device Regulation (MDR) transition delay in an effort to avoid shortages. The move gives medical device manufacturers more time to certify their devices under the new MDR rules. I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food Safety Stella Kyriakides said. “This will help give clarity to manufacturers and ensure that patients can access the essential medical devices they need. This is our top priority. The delay does not modify MDR’s current safety and performance requirements. Instead, it gives manufacturers more time to move from the old rules to the new requirements. It also removes the “sell-off” date that would have prevented the sale of products already on the market but still in the supply chain and not yet received by the user before the transition period ends.”


Combination Products Guidance

FDA Wants More Diversity in Clinical Trials

“The U.S. Food and Drug Administration says companies that produce drugs and other medical products should submit plans for how they will increase the number of Blacks and other underrepresented groups in clinical trials, the agency said Wednesday. Though racial and ethnic minorities are affected disproportionately by certain diseases, they are frequently underrepresented in medical research, the FDA said in a news release. Barriers to participation include suspicion of doctors, religion, health illiteracy, and lack of understanding of clinical trials.”


The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR

“The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes,2 which is in its third edition since its 1996 release. The FDA QSR has not been updated since its 1996 release and needs to be brought to the current state of the art. Incidentally, the first edition of ISO 13485 was released at about the same time as the initial QSR, so 13485 has been updated twice while the FDA’s regulation has not been updated.”