The Evolving Regulatory Landscape of 3D-Printed Medical Products
The concept of making personalized devices doesn’t require new regulatory processes During the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops...
View ArticleThe Patient’s Voice Enhances FDA’s Approach to Drug Review and Development
Public meetings helped fulfill an FDA commitment one year ahead of schedule read more
View ArticleUtility NERC Compliance Programs Challenged by New Risk-Based Approach
Solid record-keeping and document management are key If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also...
View ArticleInside Quality Digest Live: Jan. 13, 2017
FDA’s MRI program, better coaching, Olympus Vanta XRF analyzer, and more I’m pinch-hitting for my co-host Mike Richman in the wrap-up of this past Friday’s episode of Quality Digest Live. Mike was off...
View ArticleNew CDER Guidance Could Affect Quality Management Efforts
Be proactive in anticipation of new leadership and direction at the FDA read more
View ArticleFDA Touts Improved IDE Review Stats
Nearly 75 percent of Investigational Device Exemption studies are fully approved within two cycles read more
View ArticleFDA Answers (Some) Medical Device Cybersecurity Concerns
For premarket approval, it’s mostly common sense—with a few caveats Anew FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of...
View ArticleFDA Eases Up a Bit on Enforcement Gas Pedal
Fewer warning letters, but CAPAs continue to garner the most citations Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issued by the...
View ArticleManagement Responsibility for GMP Oversight and Control
Do you know where your daily operation stands at any given moment? Historically, the Food and Drug Administration (FDA) has cited the Supreme Court decisions of United States v. Dotterweich (1943) and...
View ArticleWill You Be Ready for a FSMA Audit?
Four tips to pass an FDA audit 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...
View ArticleHow to Prepare for an FDA Inspection
Five tips to help you get ready 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...
View ArticleFDA Proposes Cybersecurity Guidelines for Medical Devices
Stakeholders have 90 days to submit comments to the FDA Iwrote last month about the need to increase security for imaging devices in hospitals. The devices I cited store both personal and medical...
View ArticleBorder Crossings
Working with partners to verify the safety of imported produce 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,...
View ArticleAddressing Human Factors Relating to Combination Products
FDA seeks comments on new draft guidance Combination products represent an important and growing category of therapeutic and diagnostic products under the U.S. Food and Drug Administration’s (FDA)...
View ArticleWhy FMEA Is Not ISO 14971
Medical device risks aren’t solely a function of failure If you’re still using failure mode and effects analysis (FMEA) as your methodology to capture medical-device risk management activities, then...
View ArticleModernizing the Pharmaceutical Manufacturing Base
Continuous manufacturing has a strong impact on drug quality If we used a time machine to transport a pharmaceutical scientist from the 1960s into a current pharmaceutical production plant, it might...
View ArticleSix Tips to Make Sure Your 510(k) Submission Is Accepted
Planning and organization will help you avoid the FDA’s refusal read more
View ArticleFDA Introduces the Pre-RFD Process
Making continuous improvements in the combination products program One question that product sponsors often ask the U.S. Food and Drug Administration (FDA) is whether their medical product will be...
View ArticleThe Real Reason the EpiPen and Other Off-Patents Are So Expensive
The FDA’s unique position read more
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