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.”
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.”
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.”
