Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jón Bergsteinsson
Understanding the standard is essential
Stephanie Ojeda
The FDA’s new QMSR will harmonize with ISO 13485 for medical device quality management
Steve Thompson
An excellent technological tool that improves quality and compliance
Kelley Jacobsen
Amid rising prices, medical device supply chains need greater scrutiny and standardization
Jennifer Chu
Findings point to faster way to find bacteria in food, water, and clinical samples

More Features

FDA Compliance News
Streamlines annual regulatory review for life sciences
Facilitates quick sanitary compliance and production changeover
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity

More News

Stephen Ostroff

FDA Compliance

FDA 2015: A Look Back (and Ahead), Part 2

A review of FDA’s effect on medical product safety and oversight

Published: Thursday, January 14, 2016 - 12:19

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 this 2015 wrap-up, I’ll review the FDA’s effect on medical product safety and oversight.

Responding to Ebola

In a world where disease knows no borders, the FDA’s response to the Ebola epidemic in West Africa demonstrates how we use our scientific expertise and regulatory authorities to the fullest extent possible in addressing a tragic and global public health crisis. Our response involved collaborating with partners across government, pharmaceutical, and diagnostic companies; international organizations such as the World Health Organization; and our international regulatory counterparts. We played a key role in expediting the availability of diagnostic tests and investigational therapeutics and vaccines, as well as exposing fraudulent products marketed to diagnose, prevent, and treat Ebola. Many FDA-commissioned corps officers of the U.S. Public Health Service served on the front lines, deployed in a humanitarian mission to provide care to patients at the Monrovia Medical Unit in Liberia, one of the West African nations that were hard hit by the outbreak.

Addressing transmission of infections from duodenoscopes

This year we took steps to help protect the public from the risk of transmitted infections, including antibiotic-resistant infections, from duodenoscopes. Duodenoscopes are complex devices used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat blockages in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.

In February 2015, the FDA issued a safety communication to raise awareness about the risk of transmitted infections from duodenoscopes after it determined that the design of these devices may impede effective reprocessing, even when the manufacturer’s reprocessing instructions are followed correctly. Reports also indicated that some healthcare facilities may not have adequately followed the manufacturer’s reprocessing instructions. To address these concerns, the FDA has been working with the device manufacturers to ensure that the reprocessing instructions for their duodenoscopes are put through the most rigorous testing. The agency held a public advisory committee meeting in May to discuss the scientific challenges, and it incorporated recommendations for enhancing the safety margin of reprocessing duodenoscopes into a safety communication the following August. Also during August, the FDA issued warning letters to all three duodenoscope manufacturers, citing violations found during recent inspections. In October 2015, the FDA ordered the manufacturers to develop post-market surveillance studies of how the devices are reprocessed in real-world clinical settings.

Our foremost concern is protecting patients, and we are committed to taking steps to assure that duodenoscopes—and all reprocessed medical devices—are safe to use.


We continue to respond effectively to the 2012 outbreak of fungal meningitis linked to contaminated compounded drugs. We are implementing the Drug Quality and Security Act and continuing our inspection and enforcement efforts at compounding facilities nationwide. To that end, we have issued numerous policy documents regarding compounding and related activities to provide guidance to industry as we implement the new law. We’ve also held meetings with stakeholders, including pharmacy, physician, and consumer groups, and we have continued our active and successful collaborations with state governments.

Addressing the opioid abuse crisis

During 2015 we’ve been very focused on the growing epidemic of opioid abuse and addiction and its devastating effect on public health. This focus has required us to strike a delicate balance: ensuring that medical treatments are available for patients who are in pain, while addressing the often tragic consequences of abuse and misuse, which all too often overwhelm individuals, families, friends, and communities. Our approach is multi-pronged, from encouraging scientific investigation to improving the training of practitioners who prescribe these powerful medicines.

We believe it’s vitally important to encourage the development of abuse-deterrent formulations of opioids and to support options for medication-assisted treatment of opioid dependence. Final guidance for industry regarding the development of abuse-deterrent formulations was issued in April and several abuse-deterrent products have been approved. We are also making strides to treat the consequences of overdoses. In November, the FDA approved the first nasal spray version of naloxone hydrochloride to provide a delivery method (in addition to injection) for this life-saving medication that can stop or reverse an opioid overdose. Further, we’re working with our federal partners to improve access to naloxone.

Although we can’t solve this complex problem alone, we remain committed to making the best use of our regulatory authorities and working with our partners both in and outside government to reduce the risks associated with opioids. To continue to achieve a solution, we’ve been engaging in a comprehensive review of our many current activities related to opioids. We are identifying which measures can and should be strengthened and what further measures are needed to address this crisis during 2016.

Ensuring the safety of the medical products we regulate requires us to manage a wide range of issues across multiple scientific disciplines, and to employ scientists with the knowledge to solve today’s complex regulatory challenges. The year 2015 brought many challenges, and just as many solutions.

In my third and final part of this review, I’ll address some of our accomplishments in the areas of food, tobacco product regulation, and antimicrobial resistance.


About The Author

Stephen Ostroff’s picture

Stephen Ostroff

Stephen Ostroff, M.D., is the Food and Drug Administration’s acting commissioner of food and drugs. Before being named acting commissioner, Ostroff served as the FDA’s chief scientist since January 2014. In this capacity, he was responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. Ostroff graduated from the University of Pennsylvania School of Medicine.