All Features
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use, too.
All too often, however, design controls and risk management are viewed as a pile of “stuff”…
Howard Sklamberg
Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
In fiscal year 2015, there were more than 34 million shipments of FDA-…
Rachel E. Sherman, Robert M. Califf
In an earlier article, we discussed a pair of concepts—interoperability and connectivity—that are essential prerequisites for creating a successful national system for evidence generation (or “EvGen”). Here, we take a look at how we would apply these constructs as we go about building such a…
Taran March @ Quality Digest
They sound like words and have a mysterious dignity rolling off the tongue. Their meanings seem both apparent and elusive. If an alien delegation landed on Earth, words like these might feature in their formal greetings. They are the most expensively researched neologisms in use around the globe.…
Grant Ramaley
The Quality System Regulation (QSR) 21 CFR Part 820, aka FDA current Good Manufacturing Practices (cGMP) for Medical Devices, is what regulatory professionals should be referencing in their quality system procedures. Part 820 embodies all the major parts of the FDA quality system that are shared…
Lawrence Yu
If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might be surprising to learn that he would already be familiar with most of the processes and production techniques being used. That’s because not much has changed in…
Norman A. Paradis
The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the news that federal regulators may ban Theranos founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal…
Rachel E. Sherman, Robert M. Califf
Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current model for generating the scientific evidence that supports medical product evaluation and clinical care decisions. As a result the FDA seeks to modernize methods and satisfy expectations…
Jon Speer
If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then your risk management process is out of date. Let me tell you why.
Here’s the definition of “risk management” as defined in ISO 14971:2007—“Medical devices—…
Jill Hartzler Warner, Thinh Nguyen
Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA) regulatory authority. These products, which combine a drug, device, and/or biological product (referred to as “constituent parts”) with one…
FDA
One of the vivid images that sticks with me from my tenure at the Food and Drug Administration (FDA) is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States, many loaded full with fresh produce…
NIST
I
n the age-old struggle between humans and microbes, bacteria seem to be regaining the offensive. Only about a dozen classes of chemicals protect us from the myriad pathogens that populate our environment. Numerous agencies have warned that evolved resistance could soon render common antibiotics…
Peter Marks
Part of the vision of the Center for Biologics Evaluation and Research (CBER) is to strengthen the center as the preeminent regulatory organization for biologics. One way CBER is achieving this is through the work of the Office of Compliance and Biologics Quality (OCBQ) and the Office of Vaccines…
Ken Miller
I wrote last month about the need to increase security for imaging devices in hospitals. The devices I cited store both personal and medical information about patients and should be subject to standard security measures. Very often they are not.
Last month the U.S. Food and Drug Administration (…
The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.
When manufacturing problems…
Jon Speer
During the past several years, the FDA has been more aggressive and active in performing medical device company inspections. This has led to a far greater number of companies receiving Form 483 warning letters and citations. FDA Form 483s are a good way for your medical device company to flush $…
Grant Ramaley
The International Medical Device Regulators Forum (IMDRF) began a pilot phase for its new Medical Device Single Audit Program (MDSAP) in January 2014. This audit combines regulatory audits the manufacturer would typically face when they sell their products in certain IMDRF member countries: the…
Brandon Henning
Although the FDA’s Food Safety Modernization Act (FSMA) was passed in 2011, the reality is that the rules that went along with the law—and that truly define how it will be executed and regulated—are just now being finalized. Enforcement of these rules should really ramp up in 2016 and 2017.
Will…
Stephen Ostroff
In this third and final article reflecting on the FDA’s work to protect and promote public health during 2015, we’ll take a look at our achievements in food, antimicrobial resistance, and tobacco product regulation. In part one I shared the FDA’s 2015 accomplishments in medical product innovation…
Stephen Ostroff
In my first look back on the FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make available safe, effective, and innovative products. Because the FDA’s responsibility covers the entire life cycle of products, in the second part of…
Stephen Ostroff
Since March 2015 it’s been my pleasure to serve as the Food and Drug Administration’s (FDA) Acting Commissioner. The FDA has broad responsibilities, and I’d like to share some important accomplishments during 2015.
Tasked with overseeing products that account for about 20 cents of the consumer…
Robert M. Califf, Rachel E. Sherman
Medical care and biomedical research are in the midst of a data revolution. Put together, networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and personal devices comprise an immense new set of sources for data about health and…
The QA Pharm
Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and United States v. Park (1975) as Federal Food, Drug, and Cosmetic Act (FDCA) legal cases that establish that the manager of a corporation can be prosecuted under the…
Howard Sklamberg, Jeffrey Shuren, Melinda Plaisier
Across the Food and Drug Administration (FDA), we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive—and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review…
Russ King
As medical science has advanced, products submitted for FDA review are using increasingly complex formulations, including unique and creative combinations of drugs, biologics, and devices. Because of this complexity, combination products, by definition, may require intercenter consultations with…