Submissions and Approvals

ARTICLES

PRODUCTS

China’s Medical Device Regulations - Webinar CD/Transcript

$287.00
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

Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort

$397.00
This report explains the criteria for each pathway, how to determine which one is right for your device and strategies for success. Fictional cases illustrate how the different pathways can be used. View

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

$177.00
Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls shows you where design control and risk management requirements overlap so you can serve both with one integrated effort. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

$287.00
Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line - Webinar CD/Transcript

$287.00
The “CY2016 Annual FDA Medical Device Quality System Data” report is an information goldmine for devicemakers — a key to better inspection outcomes as well as greater quality in manufacturing. View

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? 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

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

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