regulations and standards Articles

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.

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. 

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.

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. 

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?  

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.

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. 

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. 

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. 

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.

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.

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.

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.

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.

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. 

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.

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

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! 

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.

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.

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.

What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?

“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. 

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. 

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.

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.

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?

“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

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.

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. 

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. 

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.