Advertisement

Topics

FDAnews Announces — New Brief — Device Accessories: Understanding and Implementing FDA’s Guidance

11:00 EDT 30 Jun 2017 | PR Web

When is an accessory classified as a device? Device Accessories: Understanding and Implementing FDA’s Guidance ebook shows how to determine and document whether a product is an accessory.

Falls Church, VA (PRWEB) June 30, 2017

Device Accessories:
Understanding and Implementing FDA’s Guidance
**An FDAnews Brief**
http://www.fdanews.com/deviceaccessoriesbrief        

The 21st Century Cures Act requires the FDA to classify accessories.

But, what does the FDA consider an accessory?

Device Accessories: Understanding and Implementing FDA’s Guidance explains the guidance document and gives manufacturers the tools needed to determine and document whether any of their products are a device accessory. Readers will learn:

  •     The definition of accessory and parent device from the guidance
  •     How the definition applies to “software as a medical device” (SaMD)
  •     The three-pronged approach to application of the accessory definition
  •     How to determine the classification status of an accessory
  •     The two methods of change applicable to a classified accessory
  •     The use of the de novo application process for an unclassified accessory

The brief includes a worksheet to help apply the definitions and determine if the accessory is classified.

Who Will Benefit:
Determining whether a product is an accessory requires a team to cover the various aspects in making the determination. Team members include:

  •     Product Marketing Specialists
  •     Regulatory Affairs Specialists
  •     Device Quality Specialists
  •     Design Engineering Managers
  •     Production Managers
  •     Product Documentation Specialists
  •     Risk Management Specialists

FDAnews Brief Details:
Device Accessories:
Understanding and Implementing FDA’s Guidance
Price: $177
http://www.fdanews.com/deviceaccessoriesbrief        

Easy Ways to Order:
Online: http://www.fdanews.com/deviceaccessoriesbrief            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/deviceaccessoriesbrief/prweb14469012.htm

NEXT ARTICLE

More From BioPortfolio on "FDAnews Announces — New Brief — Device Accessories: Understanding and Implementing FDA’s Guidance"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...