Product Details
Combination Products: Managing Design Controls
Planning to submit a new combination product for FDA approval? Then consider this:
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.
The Guidance addresses an often overlooked aspect of product regulation — the design control of the device component. Insufficient compliance can lead a Complete Response Letter that denies your application for failure to consider and/or address design control elements.
FDAnews has stepped into this knowledge gap with an all-new Webinar featuring Ricki Chase, former Director of the FDA Investigations Branch and now a management consultant. Ms. Chase analyzes this all-important final guidance ... for you. Prepare to learn:
- How design controls apply to combination products, including biologic/device and drug/device combinations ...
- How already available information can help speed new products to market ...
- Why a device isn’t a combination product: Designing for the differences ...
- Using human factor studies to support combination-product submissions ...
- And much more!
A Complete Response Letter can spell defeat for years of planning and design, not to mention hundreds of thousands of wasted dollars. Don’t take that risk.