Multiple Authors
By: Scott Gottlieb, Jeffrey Shuren

In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.

For instance, we announced our intention to propose an alternate approach to the traditional 510(k) clearance process, which will involve the use of modern, science-based, consensus standards along with FDA-developed performance criteria as the comparator for device review for certain well-understood technologies. The FDA currently compares new devices to predicate devices that can in many cases be as much as 40 years old. By modernizing the standards that the FDA uses to assess some new devices, it will make it easier to innovate these products, and adopt more up-to-date and rigorous benchmarks for evaluating their safety and effectiveness.

Multiple Authors
By: Lou Valdez, Dara Corrigan, Peter Stein

Regulatory experts from around the world, including the Food and Drug Administration (FDA), gathered recently to discuss issues such as regenerative medical products, international collaboration to fight antimicrobial resistance (AMR), and developing strategies to combat substandard or falsified medical products.

With “Innovation” as the theme, the Heads of Medicines Summit and the International Medicines Regulatory Authorities (ICMRA) annual meeting in Kyoto, Japan on Oct. 23-27, 2017, provided unique opportunities to share and learn about regulatory issues of mutual concern.

The gatherings bring together leadership from selected national medicines regulatory authorities (MRAs), who represent regulatory agencies of varying maturity. This year, regulators from 28 countries attended, along with representatives from the FDA, the European Commission, the European Medicines Agency (EMA), and the World Health Organization (WHO).

Mike Richman’s picture

By: Mike Richman

QDL co-host Dirk Dusharme was on vacation for our Nov. 10, 2017, episode, but we ably covered for his absence with some thought-provoking stories and great guests. Let’s take a look:

“What Really Causes Workplace Stress”

A multidisciplinary team of researchers at the University of Southern California are in the process of studying nurses as part of a 10-week project. Their results will not only tell us about the effects of stress in the workplace, but also how engineers can design and interpret experiments to improve many facets of the human experience.

Interview: Gene Morrison

Brandon McFadden’s picture

By: Brandon McFadden

The food labeling craze coupled with banner headlines about the dangers of gluten, genetically modified organisms (GMOs), and hormones are leading to increasingly absurd results.

For example, you can now buy “premium” water that’s not only free of GMOs and gluten but certified kosher and organic. Never mind that not a single drop of water anywhere contains either property or is altered in any way by those designations.

The QA Pharm’s picture

By: The QA Pharm

If I could summarize in one page the most important lessons I have learned in pharmaceutical quality assurance over the last 40 years, this is it.

When it comes to putting a procedure into written words, it doesn’t mean the words will be effective in getting people to follow the procedure.

The responsibility of quality assurance is to ensure that an effective quality management system (QMS) is put in place procedurally, is in use behaviorally, and is in control measurably.

The responsibility of management is to enable the QMS through accountability of each element of the QMS by an identified owner, to provide oversight through performance metrics, and to promote the QMS as a normal and valued part of the business—not to make the FDA happy or pass an inspection.

As I reflect on my pharmaceutical career and the many clients I have served over the years, the best results and most rewarding experiences were with those who embraced this concept.

My hope is for all my followers to use this simple graphic as a way to communicate a QMS implementation strategy.

I would be pleased to support your effort with details behind each of these points.

Dirk Dusharme @ Quality Digest’s picture

By: Dirk Dusharme @ Quality Digest


Our Oct. 27, 2017, episode of QDL looked at Ford, autonomous cars, and changes to FDA compassionate use rules.

“Ford Plans $14B in Cost Cuts as Part of New CEO’s Strategy”

Ford Motor Co’'s new CEO plans to cut $14 billion in costs, drop some car models, and focus the company’s resources on trucks, SUVs, and electric vehicles as part of a renewed effort to win over skeptical investors.

“FDA Eases Application Process for Compassionate Use”

The FDA recognizes that time is critical for seriously ill patients who do not have alternative therapies.

Scott Gottlieb’s picture

By: Scott Gottlieb

The FDA has a long history of supporting patient access to investigational new treatments. This includes working with drug and device companies through the clinical trial process that may lead to FDA approval of the treatment. We also offer expanded access programs that provide investigational drugs and devices to patients with serious conditions (generally prior to product approval) when there is no therapeutic alternative.

Each year, the FDA receives more than 1,000 applications for the treatment of patients through expanded access, also known as compassionate use, and the agency authorizes the vast majority (about 99%). The FDA recognizes that time is critical for these seriously ill patients who do not have alternative therapies, and who cannot take part in a clinical trial of an investigational therapy.

Mike Richman’s picture

By: Mike Richman

We cover a wide range of topics on QDL most weeks, but our latest episode, from Friday, Oct. 20, 2017, provided a steady drumbeat of technological detail. Here’s what we chatted about:

“Energy Harvested from Evaporation Could Power Much of U.S., Says Study”

Renewal sources of energy like solar or wind are great... if the sun is shining or the wind is blowing. According to Columbia University researchers, however, the process of evaporation may be able to provide access to more reliable sources of power.

“New Handbook Helps Medical Devices Sector Improve Its Quality Management System”

ISO 13485:2016, the quality management system standard created just for the medical device industry, allows users to balance safety, efficiency, and good stewardship of their companies. ISO’s new handbook helps users, registrars, and certification bodies properly interpret the standard.

Jon Speer’s picture

By: Jon Speer

How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two can end up getting confused. When do you use one or the other?

There tends to be a lack of clarity out there because you’ll get different answers, depending on whom you ask. Sometimes it all comes down to context, which we’ll take a look at.

General definitions

When we’re asked about design validation and clinical evaluation, here’s how we look at them in general terms:

Design validation: This is a key requirement for proving that your medical device meets the needs of the defined end-user. It is an element of design controls and is really about proving that the product developed is the correct device in the first place.

Ann Cleland’s picture

By: Ann Cleland

If your hospital or clinic uses a Windows 7-based version of a Siemens PET/CT or SPECT system, it could be vulnerable to attack by a relatively low-skill hacker, according to a July 26, 2017, security advisory from the company.

The Industrial Control System Cyber Emergency Response Team (ICS-CERT), a division of the U.S. Department of Homeland Security, also released an advisory on the vulnerabilities, each of which were scored at a “critical” level of 9.8 out of 10 on the Common Vulnerabilities Scoring System (CVSS). And recently, the FDA recalled 465,000 pacemakers after finding vulnerabilities that could let hackers reprogram the devices.

Both advisories note that the exploitability of these vulnerabilities depends on an organization’s configuration and deployment environment. In a network that lacks proper segmentation or other access controls, a successful hack of a medical device could open a portal into the larger network.

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