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Courtesy of EMERGO by UL, by Sarah Fitzgerald
Background on Q2 FDA GUDID compliance letters
As reported June 9, 2023 , a few months ago, the US Food and Drug Administration (FDA) began sending out system-generated emails when the agency determined there was an apparent discrepancy between the company’s device listings and Unique Device Identification (UDI) information on the Global Unique Device Identification Database (GUDID). These letters did not appear to consider if there might be an exception from UDI that applied for the relevant device(s), such as if the device was Class I and exempt from good manufacturing practices (GMP) requirements.
Emergo by UL guidance on FDA GUDID letters
Emergo by UL advised that any company receiving such a letter first review their situation to see if there are gaps, and then take the appropriate action, which might range from updating the device listings and/or GUDID databases to obtaining appropriate UDI numbers and setting up a GUDID account. Although the FDA letter made it clear that an organization already in compliance did not need to reach out to the FDA, we advised that companies whose devices were exempt should reach out to explain the situation and why it is not relevant to meet UDI and GUDID requirements to ensure that the FDA knows that you have reviewed the information and are not out of compliance. It is always important to take FDA communications seriously.
FDA response to manufacturers' responses
We have become aware that in response to companies contacting the FDA regarding GUDID, the regulator is often sending out a form letter. In that letter, the FDA essentially lists several of the potential exceptions, and states that if the company and/or devices (as relevant) meet one or more of those exceptions, than no further follow-up with the FDA is necessary. Instead they recommend ensuring there is appropriate documentation. The exceptions noted by the FDA in this letter include:
The FDA provides actions that can be taken, including ensuring that the GUDID and device listing information is correct and making any necessary updates, which may include populating the “Commercial Distribution End Date.” They note that for additional assistance or questions regarding this response to reply directly to their email response, or for other UDI-related questions to contact the FDA UDI Help Desk.
Additional Emergo by UL guidance to manufacturers
If you receive an initial letter from the FDA indicating that there is an apparent discrepancy in device listings and GUDID information, it is important to review your situation and take appropriate action, which may include updating the device listing and/or GUDID information. Although not required, if an exemption applies, Emergo by UL recommends reaching out to the FDA to explain why you are exempt, as this helps demonstrate that you have reviewed the FDA’s concern. As is typical within a medical device company, it is important to document your review of any apparent discrepancies and, if applicable, any actions taken.
If you receive an FDA response letter after letting the FDA know that you believe yourself exempt, then we do not recommend any further action other than documentation. Of course, if you have questions, need additional assistance, or otherwise feel a need to follow-up with the FDA, that can be done, as described in the FDA letter. If you want assistance, you can also contact Emergo by UL and our US FDA medical device regulatory experts can address your UDI questions and concerns.
Sarah Fitzgerald is Senior Consultant, Quality and Regulatory Affairs at Emergo by UL.
From https://www.tordent.com/
It is with great sadness that we are announcing the closing of the Toronto Academy of Dentistry effective July 31, 2023.
Unfortunately, navigating through the pandemic and the slow rebound of in-person events, has crippled the Toronto Academy of Dentistry.
On behalf of the Toronto Academy of Dentistry, we would like to take the opportunity to thank our four Toronto Component Societies and their members, our Past Presidents and Board of Directors, our industry partners and all our committee volunteers for their relentless hours of dedication and unwavering support.
The Toronto Academy of Dentistry has been a resource to the dental profession since 1890, dedicating its efforts to education, networking and engaging the dental community.
Over the years we have led the way in offering, championing and supporting our dentists in creating educational Category 1 (core) lectures. Since 2016 we have had over thirty Category 1 (core) lectures approved. We are proud to have held the Winter Clinic for 85 years, bringing together dentists, their staff and industry. We hope you have enjoyed this event.
Our benevolent work has supported SickKids, Holland Bloorview Kids Rehabilitation Hospital and AboutFace and our efforts have made a difference in the lives of many.
Without all of you, we would not have been able to raise and donate over $594,000 to Holland Bloorview Kids Rehabilitation Hospital, over $313,000 to SickKids, and over $4,500 to AboutFace. This is something that we should be very proud of. In June 2023, the Toronto Academy of Dentistry was honoured by Holland Bloorview by having a procedure room dedicated and named “Toronto Academy of Dentistry Pediatric Dental Room”.
As we prepare to close the Toronto Academy of Dentistry, please be advised to download and print ALL CE Certificates issued by the Toronto Academy of Dentistry by August 31, 2023.
After August 31, 2023, should you need proof of these certificates, they will no longer be available. Please e-mail info@tordent.com for any assistance.
We thank you for your support and we wish you all the best.
The Toronto Academy of Dentistry
Webinar will take place Wednesday, July 19, 4:00 PM - 5:00 PM ET.
The Importance and ROI of Indoor Air Quality Monitoring in the Dental Setting
The information presented will prepare you to interpret indoor air quality (IAQ) by walking through each of the essential data points and risks that contribute to the overall IAQ. This will also help you to implement a successful IAQ strategy and continue to set your organization apart with the highest health and safety standards.
After participating in this webinar, participants will be able to:
The presenter, Dinesh Wadhwani is an air quality expert and serial entrepreneur in the technology and life sciences industry. He is the founder and CEO of ThinkLite and works closely with Fortune 500 companies, townships, and enterprises across the globe to improve IAQ. Dinesh works with his close-knit team of engineers to create technological solutions that solve more significant problems that corporations must address beyond energy efficiency and cost savings. The solutions he has pioneered have the power to improve more than just corporate financial considerations they have a direct impact on improving and protecting the lives of employees and customers across all industries. Examples include pharmaceuticals, agriculture, poultry, data centers general health, and most relevantly, a technology solution that tracks levels of pathogens in the air in indoor public areas and facilities, including COVID-19, amongst other viruses; so that they can be addressed, managed, and mitigated effectively to maximize safety in the facility. He is a vegetarian and passionate about environmentally friendly technology and lifestyle.
Click here to register.
June 22, 2023 - Institute for Research on Public Policy (IRPP)
The federal government’s new Canadian Dental Care Plan is a significant step forward in reforming dental care and one of the biggest expansions of medicare in 50 years. However, the authors of a study published by the Institute for Research on Public Policy argue the “payer-of last-resort model” the government has chosen to implement the plan falls short of providing equitable access to primary and preventive dental care.
The government pledged $13 billion over five years in the 2023 budget to provide dental care to Canadian families without private dental insurance whose income is less than $90,000 a year. The plan is being rolled out in phases: coverage was extended first to children under 12 years old at the end of 2022; children under 18 years old, seniors and those with disabilities will receive coverage by the of 2023; and then all families that meet the income threshold by the end of 2025.
Colleen M. Flood, the report’s lead author and the incoming dean of the Faculty of Law at Queen’s University, and her co-authors identify four broad policy goals that should guide future dental care reform: universality, fairness, accessibility and accountability. And they weigh the pros and cons of six possible options for achieving these goals – including cash payments, refundable tax credits and transfers to the provinces and territories.
They argue that federal, provincial and territorial governments should work together to create an arm’s-length agency that would be federally funded and empowered to regulate issues such as user charges and extra-billing. The agency would also be tasked with collecting data on oral health to monitor accessibility, use and quality of care.
This would avoid intergovernmental squabbles over the constitutional division of powers and would be the most effective and efficient way to achieve broad coverage, the report concludes.
“Canada has an opportunity to revolutionize its dental care system and provide equitable access to quality care to everyone in Canada,” said Flood. “With a strong evidence base, Canada will be able to build a better dental care program that not only provides universal coverage, but also ensures that care is received by those who need it most.”
Read the Published Report
June 21, 2023 - Public Services and Procurement Canada
On June 21, 2023, Public Services and Procurement Canada announced it had reached the next milestone in the procurement process to establish the Canadian Dental Care Plan.
Over the past 6 months, Public Services and Procurement Canada (PSPC) and Health Canada have worked extensively with qualified suppliers to collect feedback and further refine the requirements of the plan. Today, the Minister of Public Services and Procurement, and the Minister of Health, announced that a Request for Proposal has been issued directly to the pre-qualified suppliers.
“Our government is committed to completing an open, transparent and competitive procurement process to help implement the Canadian Dental Care Plan. After effectively collaborating with the qualified suppliers, issuing this Request for Proposal marks an important step towards ensuring access to quality dental care for Canadians,” said Helena Jaczek, Minister of Public Services and Procurement.
This phased approach to selecting a provider for the Canadian Dental Care Plan is helping ensure the government delivers on its commitment to open and fair procurement processes, while benefiting from the ideas of potential providers to ensure the best value for Canadians in delivering this important dental care plan.
Quick facts
The first stage of the procurement process for the Canadian Dental Care Plan took place between July 25 and August 22, 2022, when PSPC issued a Request for Information that sought input from industry on potential requirements and models for the new plan.
As the second stage of the process, PSPC issued an Invitation to Qualify (ITQ) that was open from October 28 to December 5, 2022. This ITQ invited suppliers with expertise in the field of dental and health claims processing to express their interest in becoming a qualified supplier. In January 2023, the Government of Canada selected 3 qualified suppliers to participate in the following stages.
Between January and May 2023, PSPC and Health Canada worked with the qualified suppliers to gather feedback and recommendations to inform requirements for the Canadian Dental Care Plan and the resulting Request for Proposal.
June 6, 2023
FDA Announces Additional Steps to Modernize Clinical Trials
Agency Requesting Feedback on the Draft Recommendations and How They Should Be Applied to Increasingly Diverse Trial Types and Data Sources
Source: FDA.gov
Today, the U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.
“A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients,” said FDA Commissioner Robert M. Califf, M.D. “These draft recommendations propose a major step forward in this work. Building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials and generate meaningful results.”
GCPs are essential to help ensure the safety of trial participants, as well as the integrity of the data generated from trials. Over the years, the clinical trial enterprise has been viewed as costly, inefficient and constrained by inadequate collaboration and insufficient utilization of technology, data sources and innovations in design and conduct. The COVID-19 pandemic highlighted many of these challenges, while also spurring the development of new approaches.
“These draft recommendations were developed with the aim to streamline trials, making them more efficient and flexible as the trial enterprise continues to evolve,” said M. Khair ElZarrad, director of the FDA’s Center for Drug Evaluation and Research’s Office of Medical Policy. “We hope these recommendations, once finalized, will encourage thoughtful approaches to conducting clinical trials with a focus on participant safety and data integrity.”
ElZarrad led the ICH Expert Working Group in developing the ICH E6(R3) draft guideline. Academic clinical trial experts from various ICH member countries also played an important role in informing the work of the expert group.
This draft guidance, once finalized, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements. These elements have the potential to make trials more efficient and less burdensome. Additionally, the modernized GCP recommendations encourage the use of fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors could potentially facilitate more agile data collection and assist with patient recruitment.
The FDA recently issued other documents that complement these draft recommendations. The agency supports the adoption of innovative trial designs, when appropriate, and in May released draft guidance proposing recommendations for the implementation of decentralized clinical trials. Regarding DHTs, the agency also recently released a DHT framework document to guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
In addition to the recommendations supporting the modernization of trials, the principles outlined in the draft recommendations aim to make trials more efficient and potentially accelerate evidence generation for medical products by:
As part of the FDA’s established process, this draft guidance will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH member countries before finalizing the ICH guideline.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Excerpts of an article published in the Western Standard Click Here to read the full article
by Christopher Oldcorn
The department of Health said it has concerns as the cabinet expands its national dental care program, private employers currently offering dental care to most Canadians nationwide may transfer the expense to taxpayers. “It is something we are concerned about,” Lindy Van Amburg, director general of the task force, told the Senate Social Affairs committee.
Bill C-47 the Budget Implementation Act states all employers offering dental coverage must report this information to the Canada Revenue Agency by December 31. According to Blacklock’s Reporter, failure to comply could result in fines of $100. Van Amburg described this requirement as a data collection exercise.
According to the Canadian Dental Association, approximately 32% of Canadians do not have dental insurance. The current government program provides a tax-free payment of $650 per year for children under 12 in households with incomes below $70,000. The Cabinet suggested expanding the program to include individuals of all ages living in households with incomes below $70,000. Additionally, households earning between $70,000 and $90,000 would be eligible for reduced grants under the proposed plan.
“Are there any provisions or mechanisms the government can use to monitor and prevent the practice of clawing back coverage by insurance companies?” asked Sen. Sharon Burey (ON).
Parliament could not force employers to keep their plans, said Van Amburg. “The levers that exist in provinces — we’ve seen them used in Québec and other places, where they can legislate or regulate the coverage employers need to provide — is provincial and territorial jurisdiction,” said Van Amburg. “Those levers will not be available the same way for a federally delivered plan. But certainly, it's something we are concerned about and looking at very carefully as we finalize the design of the plan.”
The Canadian Dental Hygienists Association (CDHA) expressed concerns on October 27 during testimony at the Senate National Finance committee. The CDHA was worried employers might choose to end private dental plans to save money.
Fundraising for the DIAC Future of Dentistry Survey 2023 has been quite successful, but we're not at our goal yet - to fully fund this important program!
If your company is not yet listed as a sponsor below, please consider adding your support to this cause.
For more info or to commit to a sponsorship, please email info@diac.ca
Thanks to those who have committed already:
As many DIAC Members may already know, our tireless Executive Director Rhonda Lawson is retiring at the end of June. As DIAC's executive director since 2018, Rhonda has been instrumental in implementing new programs for the Association, revitalizing existing programs, and supporting and sustaining our organization through the difficult pandemic years.
Rhonda's governance expertise has allowed DIAC to flourish during her tenure. The Board of Directors and Committees of the Board are highly engaged, focused and productive. It is thanks to Rhonda that DIAC has its current Mission and Vision statements and the Strategic Plan that Rhonda facilitated in 2019 has served the Association well in the years that have followed.
In fact, the Board is thrilled that a new Strategic Plan - under development since the Board's Offsite in February - will steer and shape the Association in the coming years, even after Rhonda has retired. She leaves a substantial legacy at DIAC and her presence will be greatly missed, even as her contributions to the Association continue to serve us.
Rhonda's innumerable contributions to DIAC mean that she will leave very big shoes for her successor to fill, but the Board of Directors has confidence that the incoming Executive Director will be an extremely valuable addition to the Association.
From April 1st until June 30th, Rhonda and DIAC's new Executive Director, Hafeeza Bassirullah will be working together to ensure a smooth transition for the many programs and services DIAC provides our members.
We would like to extend a very warm welcome to Hafeeza!
Hafeeza Bassirullah, Ed.D
As an accomplished leader with proven experience executing programs, defining and shaping strategies, and transforming organizations, Hafeeza has extensive expertise implementing initiatives, policies, and programs to successfully enhance organizational effectiveness, create long-term partnerships, and deliver on the mission of organizations.
Before joining DIAC, Hafeeza worked at the Real Estate Institute of Canada where she redefined, expanded, and elevated the organization’s educational programming. Previously, at the College of Immigration and Citizenship Consultants, she established the Education Department and developed the nationally recognized education program for the profession. She also championed change management principles which improved the overall operations, advocacy, and educational standards of the organization.
At the Ministry of Health and Long-Term Care, Hafeeza worked with a team to transform the landscape of emergency management in the province of Ontario, enabling and empowering hospital staff and other health workers to make informed decisions during health emergencies.
As an Instructor of health promotion courses at the Toronto Metropolitan University, Hafeeza inspires and motivates students to learn and be leaders and enablers in promoting health from a holistic perspective.
Hafeeza holds a Doctor of Education degree with a focus on Curriculum, Teaching, and Learning from the University of Toronto and a Master of Education degree with a focus on Adult Education.
As you are likely aware, members of the Public Service Alliance of Canada (PSAC) are currently on strike. This represents approximately 159,000 employees that provide a range of services for the public throughout the Federal Government.
Some of these employees do provide a range of services for regulated parties and health care professionals subject to the Food and Drugs Act including:
1. Submission intake and initial processing prior to review,
2. Clinical trial application intake and management
3. Issuance of medical devices licences
4. Special Access Program intake and support
During this labour disruption, essential services will continue to be delivered; however it is possible that you may experience delays. We apologize for any inconvenience and assure you that we are doing everything possible to mitigate the impacts during this time to the extent possible. Additionally, as it may be difficult to access some Government of Canada buildings many scheduled in person engagements are now being held virtually during this time.
The Government is making every effort to come to an agreement with the PSAC and return to normal operations as soon as possible.
Thank you for your patience.
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