Research and Development

ARTICLES

FDA Seeks to Improve Medical Devices for Women

Improving analysis and data collection will require the development of common data elements for sex and gender to be included in some prominent medical device registries, said FDA Commissioner Scott Gottlieb.  Read More

PRODUCTS

Medical Device Software and Risk Management - Webinar Recording/Transcript

$287.00
It’s important for everyone involved in device design, cybersecurity and regulation to understand these issues. Dan O’Leary, simplifies the knotty area of FDA and international device regulation. View

Top Tips for Establishing Device Supplier Quality Metrics - Webinar Recording/Transcript

$287.00
You need to take your supplier quality metrics to the next level. The “Second Data Tier” — used in Compliance and Productivity Metrics — allows for stronger problem prevention and risk management of both internal and supplier processes. View

Corporate Compliance & Liability - Webinar Recording/Transcript

$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View

Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript

$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View

MDR Adverse Event Codes for Devicemakers - Webinar Recording/Transcript

$287.00
What devicemakers know is that MDR reporting is slated to change, with the old coding system going obsolete and new challenges arising to completion of Form 3500A. What many devicemakers still don’t know — but need to — is that the FDA is ready to assist you, with a free downloadable tool known as eSubmitter. View

Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript

$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View

Medical Devices and the FDA Reauthorization Act of 2017 - Webinar Recording/Transcript

$287.00
Many devicemakers are viewing changes in the FDA Reauthorization Act of 2017 (FDARA) as a good thing, but the devil is in the details — and some of those details start taking effect next month. It’s time you got up to speed. View

Real World Evidence and the NEST Program: An FDA Perspective - Webinar Recording/Transcript

$287.00
The FDA is working with stakeholders across the medical device community to simplify the evaluation of new medical devices via Real World Evidence (RWE). A key component of that effort is the National Evaluation System for Health Technology, or NEST … and it could benefit you. View

Nine-Volume Title 21 CFR Set 2018

$585.00
The federal government has compiled the new 2018 CFR volumes.






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Investigations Operations Manual 2018

$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View

Advertising & Promotion Hot Topics in Today’s FDA and FTC Landscape - Webinar Recording/ Transcript

$287.00
Drug and device advertising, marketing and promotion has come a long way from 30-second TV spots. These days the cutting edge is social media, product placement, engaging influencers, reality TV, pop-up shops and more. View

Top Tips for Dealing with the FDA - Webinar Recording/Transcript

$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View