Regulations and Standards
The Evolution of Medical Device Classifications
April 11, 2023
The Food and Drug Administration (FDA) began regulating medical devices in 1976, when U.S. President Gerald Ford signed into law the Medical Device Amendments Act (MDAA) to the Federal Food, Drug, and Cosmetic Act of 1938. From those amendments, the FDA wrote proposed rules to ensure medical devices were compliant with the MDAA. The body of finalized rules was promulgated in 21 CFR Parts 800-1299. That federal code ushered in the FDA’s classifications of medical devices based on the level of risk to end users: Class I, II, and III.
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Regulations and Standards
The Delayed MDR Transition in Europe
February 21, 2023
This article is Oliver’s official coverage of the changing Medical Device Regulation (MDR) in Europe. New insights will be added to the top of the page. Please bookmark this page and return to stay updated on the latest news and insight on MDR changes.
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Regulations and Standards
History of Expiration Dates
February 14, 2023
The world has lived in an age of expiration dates for about 50 years. Britain’s Marks & Spencer stores started putting expiration dates on foods in 1972 after overhauling their chain-wide line of cakes that was steadily losing ground. The dates were intended to boost sales with proof of quality-mindedness more than anything else.
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Regulations and Standards
An Evolution of Vigilance
December 6, 2022
Since its inception, the pharmaceutical industry has been required to meet myriad, sometimes conflicting, priorities. And while patient safety has always been the cornerstone, early warnings still serve as sobering reminders for constant watch in an ever-evolving marketplace.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
A Shift to Data Driven Material Selection
November 28, 2022
Over the past couple of years, supply chain issues have been a common concern for everyone in the medical device and packaging industry. Companies have had to find ways to pivot or make do with the supply they have, and all of this has companies thinking. Some of the questions I’ve been hearing from colleagues in the industry are: How can we be better prepared should the industry experience supply chain issues in the future? Are medical device manufacturers’ (MDMs) specifications too restrictive? Do tradenames need to be listed in specifications? Why can’t the focus be on what really matters to us—performance characteristics?
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Regulations and Standards, Packaging Education and Design
Something Wicked This Way Comes to Packaging
September 13, 2022
Unlike the 1962 Ray Bradbury novel, however, Wicked Stability (WS) has nothing to do with creepy traveling carnivals. News of this ambitious and ground-breaking Kilmer Innovations in Packaging (KiiP) project is traveling fast, and its implications are timely, relevant, and positive.
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Regulations and Standards, Packaging Drivers
Unwritten Rules of ISO 11607
June 13, 2022
Many industry veterans know that parts of ISO 11607 are up for interpretation. There are portions you shall (must) follow, and there are areas that are left up to you and your organization to determine how they relate to your products. This is our quick, expert guide to the areas of ISO 11607 that are more open to interpretation than others.
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Regulations and Standards, Packaging Education and Design, Medical Packaging Updates
Packaging 101: ISO 11607
March 21, 2022
When you first enter the medical packaging industry, you’ll frequently hear about ISO 11607. But what does it mean, and why do you need to know about it? Here, we share the top six things you need to know about ISO 11607.
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Regulations and Standards, Packaging Education and Design
Healthcare Packaging: Change is the New Normal
February 7, 2022
It’s no secret that one of the biggest challenges faced by today’s healthcare packaging engineers is change management. The industry is moving faster than ever. Both external and internal forces are requiring packaging engineers to be much more proactive as they consider changes that may impact the packaging system; and all of this comes as international regulatory bodies heighten their expectations of healthcare organizations.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
Unique Device Identification System for Medical Devices – Part 1
November 29, 2021
Under various medical device regulatory jurisdictions worldwide, the Unique Device Identification (UDI) System is being developed to facilitate adequate medical device identification through distribution and use. Healthcare providers, distributors, group purchasing organizations, payors, researchers, and others are using UDI for supply chain efficiency, tracking medical devices in the electronic health record including track and trace, comparative effectiveness research, electronic procurement, and a multitude of other information. This article, the first in a 2-part series, will give you a quick overview of the basics of UDI and its importance in the track and trace process at medical device companies. In this part, let’s talk through the basics–including what it is and why it matters.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
Human Factors & Usability Interview: Part 2
October 26, 2021
Last week, we had the pleasure of talking with Shannon Hoste, President of Agilis Consulting Group, about her expertise in human factors and usability. Shannon led the CDRH Human Factors team and is also on the AAMI HE – Human Factors Engineering Committee. Here is the second part of our interview with Shannon. Read Part 1 of our interview.
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Regulations and Standards, Medical Packaging Updates
Cracking the Age Old Dilemma: Compliance or Quality?
September 7, 2021
I recently read an article from Medtech Insights on how device giants Stryker and Baxter embrace a quality first culture – and yield positive results. In the article, Stryker’s Medha Trivedi, the company’s senior director of global quality and operations said something that resonated.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
Power to the PDUFA
August 31, 2021
The Prescription Drug User Fee Act was passed into law by Congress in 1992. The PDUFA implemented a fee-based framework for New Drug Applications and Biologics License Applications. One of its primary objectives was to provide funding to speed up the glacial pace of the FDA’s new drug review process. Specifically, the fees generated would allow expansion of staffing for FDA reviews, in addition to other performance goals. To further track its effectiveness and refine direction over time, the Act would require a reauthorization vote by Congress every five years. The FDA is currently operating under PDUFA VI. In 2022, Congress will hold a vote on PDUFA VII to govern fiscal years 2023-2027.
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Regulations and Standards, Packaging Drivers
Updates on China’s New Regulations for Medical Devices
June 15, 2021
In late March 2021, China’s National Medical Products Administration (NMPA, formerly CFDA) published the revised Regulations on the Supervision and Administration of Medical Devices. This version of regulations was postponed until March 2021 due to re-prioritization of tasks of NMPA in response to the COVID-19 pandemic. The updated regulatory framework was slated to take effect on June 1, 2021.
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Regulations and Standards, Packaging Drivers
Country-by-Country: Asia’s Regulations on Medical Packaging
June 1, 2021
Asia is emerging as one of the fastest-growing regional markets in the East. A number of dynamics are driving growth, including expansive government expenditure, increasing healthcare needs of aging populations, and greater accessibility to healthcare overall. As Asia opens these new dimensions, it is bringing economies, commerce, marketing and social issues such as healthcare, to the fore. The double-digit growth has highlighted the need for more standardized, precise medical device regulations, which have varied widely across APAC countries, until now.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
MDR Starts on May 26; Read This to Get Ready
May 25, 2021
MDR has been a part of our vocabulary since 2017. It was postponed last year, but the time is finally here. On May 26, 2021, the European Union Medical Device Regulation (or, EU MDR) will finally be implemented. Since the announcement of this new regulation, all notified bodies and medical device manufacturers across Europe have been actively preparing. By now, stakeholders are aware of what must be done. But with that said, it is an extensive regulation, so we also know companies who are wondering if they’ve interpreted MDR correctly, and more importantly, if they comply or not.
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Regulations and Standards
From Machine Operator to Head of Quality
March 30, 2021
I raise up my voice—not so I can shout, but so that those without a voice can be heard. We cannot succeed if half of us are held back.
- Malala Yousafzai, recipient of the Nobel Peace Prize
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Regulations and Standards, Packaging Education and Design, Packaging Drivers, Medical Packaging Updates
Improved Labelling for Sterile Barrier Systems
March 15, 2021
One key function of medical packaging is to inform the end user about the packaged device and how to use it safely. Most of us know the iconic symbols found in medical packaging such as “sterile” or CE that effectively communicate to healthcare professionals about the device. Additionally, packaging design cues like chevron pouches and thumb notches help healthcare professionals to use proper opening techniques required for aseptic presentation. Things get more complicated with double or triple barrier packages when the validated sterile barrier is not clearly identifiable at the point-of-use. Thankfully, new sterile barrier symbols from the Sterile Barrier Association (SBA) will help to indicate just that!
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
ISO 11040-7: Packaging In-Process Pharma and Prefilled Syringe Tubs
January 13, 2021
For those in the medical device and healthcare packaging industries, whether you are just starting out or have been in the field for 30 years like me, we understand ISO 11607. We live and breathe it every day. Whether we are considering the device itself, the package design, making a material selection, or considering sterilization and transportation, ISO 11607 is our guide.
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Regulations and Standards, Medical Packaging Updates
MD&DI Interviews FDA Commissioner
November 3, 2020
How the FDA continues to generate the science and data of a pandemic, keep the public health on active duty, and serve innovation, in the year that upended the world.
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Regulations and Standards, Packaging Drivers
Out with the old? Changes to EO sterilization may help meet new challenges.
August 12, 2020
Ethylene oxide (EO) sterilization has remained largely unchanged for decades, but recent changes have shaken up the industry. Concerns with the carcinogenic nature of EO and the alleged levels of emissions from sterilization facilities led to subsequent closures of some contract sterilization facilities. EO is a highly effective sterilant with many advantages, but it is also toxic and classified by the U.S. Environmental Protection Agency (EPA) as a known carcinogen.
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Regulations and Standards, Medical Packaging Updates
FDA Pilots Programs to Enhance Traceability
July 30, 2020
What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?
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Regulations and Standards, Packaging Drivers
“They”
July 7, 2020
“They.”
An entity all its own:
“Why did THEY make it this way?”
“What were THEY thinking?”
How many times have I uttered those or similar phrases about “they” in my career?
Who are “they” anyway?
In my case, my “they” has often been the people who wrote the ISO 11607 or ASTM standards that we use to test our packages.
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Regulations and Standards, Packaging Drivers
Global Medical Device Regulations & Harmonization Efforts of Sterile Medical ...
May 26, 2020
We are going through a global health crisis which is unprecedented in our lifetime. This is a global pandemic which requires an international response. As such, it becomes even more important to understand global harmonization of best practices in the healthcare industry.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
ISO 11607 & EU MDR: Getting Clarity on Risk Management
April 29, 2020
A year after the publication of ISO 11607-1/2 revisions, seeking further harmony with 2020’s EU MDR, new changes are in the works.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers, Medical Packaging Updates
Seal Strength Testing: Is 1 lb. Still the Go-To Metric? ASTM WK57656 Update
March 13, 2020
A few years ago, I started a journey on behalf of packaging professionals everywhere—to validate or debunk the 1 lb. standard for seal strength testing. For as long as I can remember, it has been a popular topic of conversation and debate in every gathering or get-together with veteran and beginning packaging engineers alike. We discuss where the 1 lb. standard came from, why 1 lb. became the go-to metric, and if 1 lb. is right for every package out there.
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Regulations and Standards, Packaging Drivers
Finding Clarity with Vision Systems
February 6, 2020
Are you using machine vision systems in your medical device or pharmaceutical inspection processes? The prospect of automated, consistent quality inspections is thrilling to every medical and pharmaceutical producer. Yet, if the concept is so great, why isn’t every health care manufacturer already on board?
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Regulations and Standards, Medical Packaging Updates
Treating Disease at the Speed of Life?
January 31, 2020
“It’s very much a change. In areas of high unmet need, FDA seems to be committed to getting medicines to these people as fast as possible.”
–Alethia Young, biotechnology analyst, Cantor Fitzgerald
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
160 Years of EtO
January 20, 2020
Industry talk continues about a future with less or no EtO sterilization. It is a sea change, even though the controversy first appeared decades ago. It is a far cry from the buzz of a 1928 discovery that the gaseous compound was an effective insecticide. EtO quickly earned a prominent role in fumigating hospital rooms and treating WW II troop rations. These successes, no doubt, fueled the expansion of EtO use to the supply side of the medical field, sterilizing instruments.
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Regulations and Standards, Packaging Drivers
Med Tech Regulatory Bosses Around the World
November 14, 2019
There is no dispute about why the med-tech industry is highly regulated. No matter how robust the sterilization or disinfection process, if the packaging and seal closures of a medical pouch are compromised, there is a significant risk of product contamination during shipping and storage that could pose a danger to the end-user. Moreover, we all know that “end-user” ultimately means you, me or someone we love.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
Sterilization and the FDA Innovation Challenge
November 7, 2019
By now, we are all familiar with the recent discussion around sterilization in the medical device industry. Ethylene oxide or EtO is the most popular sterilization modality in the industry accounting for approximately half of the market. EtO is a colorless gas, and long-term exposure can pose serious health risks. Some US communities located in and around EtO sterilization facilities have become increasingly concerned, ultimately forcing the FDA to take action.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
Are You Ready For MDR?
October 18, 2019
If you are a medical device manufacturer (MDM) or work in a support industry to the global medical device market, you are probably familiar with the date May 15, 2020. It is then that the three-year transition to the Medical Device Regulations (MDR) governing document (adopted by European Parliament in 2017), comes to a close. Every MDM that markets products in the EU is impacted by the MDR.
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