See news and upcoming events that are relevant to the medtech regulatory community - curated by the Rimsys team. Each entry is linked directly to the source article or post. Contact us to suggest an item we should share here!
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July 20, 2023
FDA Webinar - Final Guidance: Content of Premarket Submission for Device Software Functions
The FDA will be hosting a webinar for industry and other interested stakeholders to discuss the final guidance: Content of Premarket Submissions for Device Software Functions.
We're excited to join EU Commission, Competent Authority, Notified Body, and industry experts at the MedTech Summit to discuss the evolving global regulatory landscape. Rimsys will be speaking and exhibiting at the event.
The Department of Health and Human Services released its Spring 2023 Unified Agenda, which includes 78 rules pertaining to the FDA. This includes a final Quality Management System regulation (QMSR) and a proposed rule to regulate laboratory-developed tests (LDTs) as medical devices.
FDA Regulatory Education for Industry (REdI) Annual Conference
Learn directly from the FDA's regulatory experts. This course offers separate tracks for drugs, devices, and biologics and is designed to provide participants with a strong, basic foundation in the FDA's regulatory requirements.
The FDA has released a new guidance document intended to provide an overview of the mechanisms available to submitters through which they can request feedback in writing or during a meeting with the FDA regarding a planned or potential IDE application, PMA application, HDE application, De Novo request, and others pre-submission activities through the "Q-Sub" program.
UK Pro-Innovation Regulation of Technologies Review
The recent "Pro-innovation Regulation of Technologies Review - Life Sciences" released by the UK calls for plans to put in place a new regulatory pathway designed to speed the development and release of innovative technologies.
MHRA issues guidance on reporting software adverse events
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new guidance for identifying and reporting adverse events involving Software as a Medical Device (SaMD) under the vigilance system.
We're excited to reunite with our global peers and colleagues at RAPS Euro Convergence 2023. Rimsys will be presenting and exhibiting as an Visionary sponsor at the event. The conference will explore how the regulatory community has transformed traditional models, timelines and practices to achieve new heights in advancing public health.
Attending RAPS Euro? Join Rimsys for a RegUP (Regulatory Meetup) on an Amsterdam canal dinner cruise on Tusday, May 9th. We'll network, discuss regulatory trends and best practices, and share what's new at Rimsys. Enjoy drinks, some traditional Dutch cuisine, and a scenic tour of Amsterdam. Attendance is free for Rimsys customers and qualified guests.
China NMPA: Second interpretation of GB9706.1-2020 released
China's NMPA Center for Device Evaluation (MDE) has released a new interpretation of the "Notice on the Implementation of GB 9706.1-2020 and its supporting parallel standards and special standards." GB 9706.1.2020 is the China medical electrical standard that became effective May 1, 2023 (with grace period). Note - link in Chinese.
New FDA draft guidance on running decentralized clinical trials
The FDA has published new draft guidance, "Decentralized Clinical Trials for Drugs, Biological Products, and Devices." The guidance takes additional steps in support of the use of decentralized clinical trials (DCTs) where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.
Swissmedic clarifies documentation of GMP compliance for foreign manufacturers
Swissmedic, the Swiss Agency for Therapeutic Products, has issued changes to the guidance document on GMP compliance by foreign manufacturers. The updated guidance allows for audit reports to be used to demonstrate GMP compliance in certain situations where the foreign manufacturer is unable to provide certificates issues by regulators in other countries with comparable GMP control systems.
SCHEER - Call for information for updating the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
The EU's Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) has issued a call for information for updating the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical device covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting properties. The deadline for submitting information Is July 17, 2023.
New FDA draft guidance aims to ease path to AI-enabled device updates
The FDA has issued a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML) - Enabled Device Software Functions. The guidance aims to "further develop a regulatory approach tailored to artificial intelligence/machine learning (AI/ML) - enabled devices to increase patients' access to safe and effective AI/ML-enabled devices." Typically, software algorithms cannot change once cleared by the FDA. This guidance would allow for some modification within a specified scope and parameters.
The FDA's guidance, "Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act," states that the agency does not intent to issue "refuse to accept" decisions for premarket submissions based solely on a lack of a cybersecurity plan before October 1, 2023.
Switzerland: The Federal Council aims to safeguard the supply of medical devices
"The Federal Council intends to grant an extended period for the certification of medical devices, in line with the extension of the equivalent European regulation. This move aims to safeguard the supply of medical devices in Switzerland. In its session of 29 March 2023, it was informed of the steps that the Federal Department of Home Affairs is taking towards incorporating the EU Regulation of 15 March 2023. This will require an amendment of the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO)."
General Considerations for Animal Studies Intended to Evaluate Medical Devices
A new guidance document has been released by the FDA that provides recommendations on animal studies intended to evaluate medical devices for human use, when a suitable alternative to an animal study is not available.
European Commission: Q&A on extension of MDR transitional period
The European Commission has released their promised Q&A document addressing the "practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the 'sell off' periods."
FDA transition plan for medical devices that fall within enforcement policies issued during the Covid-19 public health emergency
The FDA has issued guidance to provide recommendations and expectations to manufacturers of devices that fall within certain enforcement policies issued during the Covid-19 public health emergency to transition to normal operations when the public health emergency ends.
The European Union's Council of Ministers has adopted the resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). The transition period, granted under certain conditions, extends the MDR transition through the end of 2027 for higher-risk devices and the end of 2028 for medium and lower-risk devices.