On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191. T...
Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device? If your Risk Management process is not integrated with HFE, how and when to integrate it into the product development process can be imp...
Randomized controlled trials have long been the gold standard for collecting clinical data on investigational medical devices. However, with the increasing costs of conducting trials, difficulty in tracking long-term outcomes, and sometimes mismatch ...
With the initial Brexit plans derailed and the deadline now being extended to April 12th, the trade and manufacturing industry is in a state of chaos. The constantly changing regulations have put the stakeholders in a difficult situation. In preparat...
Does your medical device Risk Management process include Usability / Human Factors Engineering (HFE)? For many devices, the manufacturer must have a process to evaluate the Usability of a medical device as it relates to safety. This can be accompli...
3D printing has a multitude of applications in the medical device field. Right from the inception of the additive manufacturing technique, engineers have been working on how this technology can serve the health care industry. Additive manufacturing h...
For medical devices, ISO (International Organization for Standardization) is one of the most significant organizations. ISO issues international standards. Often, national or regional standards organizations adopt the international standards and chan...
It is likely that you know someone who has received a ligament or tendon replacement, a cornea transplant, or a skin graft. If these tissues were derived from humans, are these products regulated by FDA? This blog will provide an overview of the regu...
Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. Wi...
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be seen in every department at those medical device companies. By default, the regulatory affairs functions have been the worst hit and are...
With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of what has changed in the new EU MDR and how as a Medical Device manufacturer you can best deal with these changes. You can read some......
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public data...
The three-year transition period to the EU MDR does not only engage the Regulatory Affairs personnel in Medical Device companies but also the entire business leadership as well. Companies are still in the three-year transition period to comply with t...
The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that lasted for 35 days. Here’s what’s going to happen: Some FDA officials carried out inspections and other critical activities wit...
The field of mobile medical applications (apps), software that run on smartphones or other mobile communication devices, has grown incredibly in both the number of applications available and the nature of the medical application. In this article, we ...
The new EU MDR is set to go into effect in May 2020. The transition to the new regulations is burdensome for some companies especially because of some newly established requirements. One such requirement is to have a Person Responsible for Regulatory...
With the fast approaching Brexit date, the possibilities of Britain exiting the EU without striking a deal are very high. Prime Minister Theresa May’s exit agreement was rejected by the British Parliament on January 15, 2019, by 432 votes to 202. T...
In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufa...
On January 7th, FDA released a working model for the software pre-certification pilot program version 1.0. The working model is open for public comments on the docket until March 8th, 2019. In our blog FDA’S DIGITAL SOFTWARE PRE-CERTIFICATION PROGR...
In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article reviews the response of the U.S. FDA to the Ebola virus and progra...
On December 22nd, 2018, the Federal Government went into a partial shutdown. Forty one percent of the FDA staff has been furloughed, which means that out of 17,397 FDA staff members, only 10,344 members have been retained for work.1 The number of fur...
FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, 510(k) submitters can voluntarily send their 510(k) to recognized organizations (“3PROs”) for review. This article provides an o...
We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was hard-hitting while some were received with a warm welcome by industry professionals. It sure is a difficult and confusing time for the medica...
Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition period to comply with the new EU MDR 2017/745. There are quite a few changes proposed in the new regulation that medical device companie...
We all know how being MDSAP certified opens doors to market a device in the USA, Canada, Japan, Brazil, and Australia. Health Canada now requires medical device manufacturers to be MDSAP certified prior to January 1st ,2019 to be able to legally mark...
Direct-to-consumer (DTC) tests, such as those marketed by 23andMe, are changing the classic paradigm of health professionals ordering and interpreting genetic testing for a patient. In this article, we provide an overview of the DTC landscape and the...
A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago. The investigation pointed out ...
The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA Commissioner Dr. Scott Gottlieb’s announcement on the renovation to the 510(k) program1 and two new pilot programs initiated by FDA: t...
Every year FDA releases an annual report for Quality system inspections and enforcement action data for the Medical Device industry. For our blog this week, we are presenting a brief analysis of the data published by the FDA for the fiscal years 2015...
The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified agenda also made it to the FDA’s Fall unified agenda published in October 2018.1 The revision will replace the existing regulation i...
The digital health software pre-certification program is FDA’s strong footstep in leading the way to support the inclusion of the digital world in the US healthcare industry. As part of FDA’s digital health innovation action plan, the pre-cert pr...
Medical devices in the UK are regulated by the directives put forth by the EU, including: Active Implantable Medical Devices Directive (AIMDD) Medical Devices Directive (MDD) In Vitro Diagnostic Medical Device Directive (IVDD) High risk medica...
In a previous blog from a few months ago on the update in the De novo pathway, we shed some light on the prices introduced through the MDUFA IV for the De Novo process. Additionally, the blog discussed how the release of the FDA guidance......
EpiPen Shortage Kids are going back to school all over the country. For many kids, an EpiPen (epinephrine injection) is a necessary addition to their back to school list. Food allergies are an increasing public health concern that affects an estimate...
Paper Based QMS vs EQMS When looking at a document management system, companies have two choices; paper based or electronic. In our experience, companies often tell us that, ‘they have been talking about an EQMS’ for a significant amount of time ...
E.M.M.A. International Consulting Group, Inc. (EMMA International) a global leader in quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries, is pleased to announce the opening of its newest...
The New Frontier in Medical Devices: Will Innovation Drive Cyber Attacks? Wearables That Diagnose by Design We can now peer into our genome and microbiome to assess our individual risk of disease, but soon dynamic data will enhance our ability to cho...
A new bill signed this month by President Trump may extend the options of terminally ill patients who want to use experimental types of drugs to treat their conditions. Traditionally, the FDA had various criteria governing the use of drugs that ha...
Independence Day is a time to celebrate our country with family and friends. July 4th is synonymous with fireworks, swimming and picnics. However, the fun of picnic and barbeque season can also bring on additional opportunities for foodborne bacteria...
Overview The opioid epidemic can be traced back to the late 1990s, when the medical community began to prescribe opioid pain relievers at a higher rate due to the information and reassurance they received from the pharmaceutical companies that patien...
Good afternoon, After a very long and cold wait, Spring is finally here! This is also the time of the year when our team at EMMA International is busy and consumed with our annual Spring conferences and annual meetings. The team and I were in......
What is FSMA? The FDA Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama in 2011. This enables the Food and Drug Administration (FDA) to provide oversight, ensure compliance with requirements, and respond effectively t...
Posted by Stephanie Bouzounis, Senior Communications Specialist Daily consumers use and consume products that have the potential to harm or enhance their health. Medications, food, and medical devices are all regulated by the Food and Drug Adm...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The AIDS (Acquired Immunodeficiency Syndrome) crisis in the early 1980s had a profound effect on blood donations. The perception that the blood supply was safe changed in the mind of t...
Posted By: Stephanie Bouzounis, Senior Communications Specialist Technology and health care have converged in the 21st century under the umbrella of what is known as digital health. What is digital health? The 21st century has seen the convergence o...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Back...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this ne...
Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical devices – like we mentioned in last week’s blog – fall into one of three classes: Class I, Class II, and Class III. Class I devices are low risk, and include over-the-cou...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The 510(k) Process In alignment with FDA’s overall vision to improve various processes, there will be updates to the 510(k) process this year. Before the updates are mentioned, a bac...
Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical device manufacturers have much to think about when it comes to registering a product internationally. Different regions and countries have different standards for registration....
Posted By: Stephanie Bouzounis, Senior Communications Specialist February is American Heart Month, according to the American Heart Association. One of the aims of this federally designated month is to raise awareness about cardiovascular disease. Th...
Posted By: Stephanie Bouzounis, Senior Communications Specialist 3D printing appears to be a novel technology in popular culture, but it has been around for over three decades. What is novel, however, is its prevalence in modern medicine. What is 3D ...
Posted By: Stephanie Bouzounis, Senior Communications Specialist The first month of 2018 is in the books, and for the Medical Device industry the outlook appears positive. The first big news item is the Medical Device tax. At the start of the year, i...
Happy New Year from EMMA International! Your ‘one stop shop’ for all your quality, regulatory, and compliance needs. The new year brings with it the halo of fresh starts and new opportunities. What hasn’t changed are the usual const...
Hacking of the Healthcare Industry Medical devices are creating new vulnerabilities in the healthcare industry that put patient care and personal data at risk. In recent years, the healthcare industry has been hacked more frequently than the financia...
Public Safety as a Priority In 1983, the FDA implemented a lifetime ban on blood donations from people deemed to be “high risk” for potential HIV infection; this included men who have sex with men (MSM). At the time, HIV transmission and infect...
Wearables That Diagnose by Design We can now peer into our genome and microbiome to assess our individual risk of disease, but soon dynamic data will enhance our ability to choose the most effective medical care. Health related apps, trackers and sof...
Spring conference season is upon us and EMMA International has just finished an exciting month of conferences with some incredible organizations we work closely with. If you are not familiar with the Medical Device Manufacturers Association (MDMA), t...
EMMA International Consulting Group, Inc., is proud to be a Silver Sponsor of The Manufacturer’s Association of Central Pennsylvania’s 2017 Annual Event. This year we will be offering one (1) complimentary ticket to the Annual Event to the...
Spring is off to a great start for EMMA International! We are beginning this spring season by offering a new, unique service to those looking to find direction for their quality and regulatory needs. If you’re not sure where you stand with a projec...
MDSAP-What Manufacturers Need to Know In 2014, the International Medical Device Regulators Forum (IMDRF) launched the Medical Device Single Audit Program (MDSAP) pilot. As of 2017, the MDSAP is in full force and fully operational. This poses the ques...
This is the time of year when many of us tend to retake stock of our homes and lives – we clear the cobwebs, file our taxes, plan our vacations, and generally organize ourselves. So, too, should we reevaluate and organize our company’s status per...
EMMA International was incredibly pleased to have hosted dozens of regional business leaders and innovators at our headquarters in Farmington Hills this month. Our ‘Meet & Mingle’ events are a great way to stay connected with colleagues a...
A recall can make all consumers especially nervous, but for a company issuing such an action, this can be evermore daunting, though it doesn’t need to be. A recall is essentially a removal of a product from the market for a defect or other issue......
President Donald Trump, in his first few weeks in office, has been forging ahead with executive orders, making good on promises made while campaigning. He has signed one such executive order (EO), “Reducing Regulation and Controlling Regulatory Cos...
Do you want the world to see your dirty laundry? If not, then EMMA International can help you prepare for the new Medical Device Single Audit Program (MDSAP). MDSAP full implementation is in effect as of January 1, 2017. The Medical Device Single ...
First, EMMA International would like to wish everyone a wonderful and prosperous new year. However, we know that a new year can also bring new challenges. In 2017, you can: Transition from ISO 9001:2008 to ISO 9001:2015 Transition from ISO 13485:20...
On June 15, 2016, the FDA issued its final rule that revised certain medical device and biological labeling regulations. The rule finalizes the FDA’s 2013 proposed rule and affects biologics, IVDs, and medical devices regulated by 21 CFR Parts 660,...
Like many industries, progress within the medical field depends on innovation. This innovation has produced novel technologies and medical device improvements that rely increasingly on data storage, software, networks, and user devices. The scale and...
ISO 13485 is an International Organization for Standardization (ISO) standard originally developed in the 1990’s, that consists of requirements for a Quality Management System (QMS) for designing and manufacturing medical devices. ISO 13485 is deri...
Within the United States, cigarette smoking is the leading cause of preventable death; accounting for over 480,000 deaths each year1. Given the health risks of tobacco use, the FDA has established regulations that aim to reduce its associated morbidi...
A need to have an effective and modern approach for a pharmaceutical Quality Management System (QMS) resulted in the International Conference on Harmonization (ICH) developing a new quality system guidance that has the ability to support the regulato...
The quality management system of a medical device manufacturer is important for several reasons, but today we are going to focus on its aims of customer satisfaction and device safety and effectiveness. There are standards in place to achieve each of...
FDA 21 CFR 820 details the regulatory requirements medical device companies must comply with to manufacture and sell medical devices within the U.S. The regulation requires manufacturers to develop and maintain a Quality Management System (QMS) to do...
In 2007, several high-profile drug safety problems triggered Congress to mandate the FDA to develop an active surveillance system, utilizing electronic health data, to improve tracking and analysis of drug safety after drugs reach the market [1]. Dur...
With the release of the Unique Device Identification (UDI) System Final Rule in 2013, manufacturers have been staring down compliance deadlines that are quickly approaching and scrambling to make sense of the new regulations. The backlash of failing ...
In Back to Basics: Complaint Handling – Part I the basic requirements for complaint handling were discussed and we left off at the topic of MDRs. From a high level, a MDR is a post-market surveillance activity required by the FDA to monitor devic...
In today’s fast paced society, innovation and progress are the name of the game, especially in the medical device industry. However, placing so much pressure on the development of new technology puts resolving issues associated with products, alrea...
Imagine, for the last five years you have worked to design a new, low-risk medical device and you are now ready to submit a 510(k) to the FDA for market approval. You do your due diligence to demonstrate the safety and effectiveness of your device......
In the past, FDA’s guidance on post approval changes made to New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Chemistry Manufacturing and Controls (CMC) has been ambiguous and hindered continuous improvement of pharmaceu...
Since its creation in 2002, the Office of Combination Products (OCP) has been tasked with developing regulations and guidance documents for combination products [1]. A combination product is a product composed of any combination of drug/device, drug/...