FDA Launches Device Software Pre-certification Pilot

The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of the new approach is to determine whether a company meets the necessary quality standard. Read More

What Device Manufacturers Can Learn From FDA’s Inspection Data

Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More


510(k) Change Analysis - Webinar Recording/Transcript

On Nov. 8, the FDA is expected to issue twin final guidances revamping the device change process and determining when a new 510(k) is required. We explain it all to you ... and outfit you with tools to comply. View

Must-Know Contracting for Non-Lawyers - Webinar Recording/Transcript

When it comes to supply contracts, it’s far better to do things right going in ... rather than pay the price down the road. In just 90 fast-moving minutes, Courtney Young Esq. of MedMarc Insurance Group walks you through the essentials of supply contracts — what to include, what to (safely) leave out, how to stand up for yourself. View

Making Sense of IVD Regulation - Webinar Recording/Transcript

Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs , and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result. View

Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation

In Tools for Faster Drug and Device Development: FDA’s New Pathways to Innovation noted FDA law expert Jim O’Reilly lays out the current landscape of drug and device development tool research. He explains how the 21st Century Cures Act has established an updated, multi-stage process for development tool qualification and explores how the FDA will implement it. View

CDRH in Transition: Navigating the New Culture of Quality

In CDRH in Transition: Navigating the New Culture of Quality he explains why compliance and quality don’t necessarily go hand-in-hand and how the center’s GMP inspections program intends to increasingly emphasize what a company is doing right over dinging them for what they’ve done wrong. View

Process Capability Indices for Medical Device Manufacturers - Webinar Recording/Transcript

In device manufacture, QSR requires, where appropriate, procedures for valid statistical techniques to establish, control and verify process capability acceptability. Particularly tricky: calculating process capability indices using data from Statistical Process Control (SPC), predominantly x-bar and R charts. Master that and you’re well on your way to cleaner inspections. View

Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View

Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript

In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View

Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript

In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View

What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View

China’s Medical Device Regulations - Webinar CD/Transcript

China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers. The price is a familiar one: Compliance with China’s regulations. View

Transforming the Medical Device Critical Process Supply Chain - Webinar CD/Transcript

Now, FDAnews has brought together two MedAccred thought leaders (from J&J and Stryker), plus a MedAccred suppler (Global Technologies) for presentation introducing you to this innovation in supply-chain auditing. View