Regulatory Affairs

ARTICLES

CDRH Continues to Grow NEST

The FDA is moving ahead with plans for the National Evaluation System for Health Technology (NEST) as one of its top CDRH priorities this year. Read More

CDRH Continues to Grow NEST

High-quality evidence at lower cost and in less time could eliminate the need for FDA premarket review of some device modifications. Read More

PRODUCTS

Biological Risk Evaluation and Management for Medical Devices

$397.00
Biological Risk Evaluation and Management for Medical Devices shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards. View

Disinfectant Testing and Validation - Webinar CD/Transcript

$287.00
Keeping cleanrooms clean takes more than soap and water. A lot more. It’s a complicated — but critical — topic for drug, device, biologics and supplement makers, and compounders too. View

Device Accessories: Understanding and Implementing FDA’s Guidance

$177.00
Device Accessories: Understanding and Implementing FDA’s Guidance explains the guidance document and gives you the tools needed to determine and document whether any of your products are a device accessory. View

Hack-Proofing Medical Devices: Ensuring Product Safety through Cybersecurity

$397.00
Hack-Proofing Medical Devices will show you how to get — and keep — control of your devices’ networked operations. View

Dealing with China’s Regulatory Authorities: Tips for Devicemakers

$177.00
Dealing with China’s Regulatory Authorities lays out the whole regulatory map — explaining which bodies are responsible for which groups of products and activities, what their particular interests are, how to deal with officials at different levels and what personal factors (education level, language, culture) should be taken into account. View

Device Design and Risk Management - Webinar CD/Transcript

$287.00
Medical device design is linked inextricably with risk management. Risk reduction measures become design inputs. Implementation verification, a risk management activity, can work as design verification too. View

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

$397.00
Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Understanding the New EU Medical Device Regulations

$397.00
Understanding the New EU Medical Device Regulations directs you through the new MDR and in vitro diagnostic device regulations (IVDR) and explains the new provisions and what they’ll mean for your business. View

Medical Device Premarket Regulatory Pathways - Webinar CD/Transcript

$287.00
There’s a new pathway to medical device sales: The premarket approval process. It doesn’t involve the usual mechanisms — IDE, PMA, 510(k) — but rather, taking advantage of provisions tucked within the 21st Century Cures Act, and proposed Medical Device User Fee Amendments (MDUFA) IV goals. A business-friendly White House helps things along. View

Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View

Supplier Contracts for Non-Lawyers - Webinar CD/Transcript

$287.00
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 Stevens 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

Guide to FDA and EU Medical Device Regulations, 2017 Edition

$397.00
NEW for 2017 — You’ll get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices. View