Edition: India  
> >

United States: FDA Releases Draft Guidance On "Software As A Medical Device" - Day Pitney LLP

Mondaq Wednesday, 23 November 2016
On October 14, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Software as a Medical Device (SaMD): Clinical Evaluation" and invited interested parties to submit comments for consideration in the final version.
Share on
Share on
Post on 
Share by
Source: Associated Press - < > Embed

News video: Device Allows Some Breast Reconstruction at Home

Device Allows Some Breast Reconstruction at Home 01:51

Doctors are testing a device that would let women do part of their breast construction at home. It’s not only aimed at making treatment more comfortable and convenient, but also giving a sense of control to women who’ve had a breast removed. (Nov. 16)

Recent related news

United States: For Medical Device And Pharma, New Law Speeds FDA Approval, Adds $6 Billion In Funding - Fox Rothschild LLP

A new federal law – the 21st Century Cures Act – will funnel more than $6 billion in funding to medical research and innovation.
Mondaq - Legal

United States: What You Need To Know About The FDA's Guidance On Postmarket Cybersecurity - Reed Smith

The FDA released its final Guidance on Postmarket Management of Cybersecurity in Medical Devices during the week between Christmas and New Year.
Mondaq - Legal

United States: Good News For Physicians: CMS Defers Penalty Due To ICD-10 Glitch - Day Pitney LLP

CMS released a statement on January 9 that the ICD-10 updates that went into use on October 1, 2016 created problems with CMS's ability to process certain data...
Mondaq - Legal

FDA issues draft guidance to better medical product labeling

(Reuters) - The U.S. health regulator issued draft guidance, recommending ways to communicate promotional materials and additional information that is not on the...
Reuters India - Health

United States: Choice Of Forum And The Parties Matter In Med Device Cases (Particularly In Minnesota)! - Fisher Phillips LLP

The medical device industry has seen a litigation boom in recent years in non-compete litigation. A new case out of the District of Minnesota involving...
Mondaq - Legal

You Might Like


Environmentally friendly: newsR is hosted on servers powered solely by renewable energy
© 2017 newsR / One News Page Ltd. All Rights Reserved.  |  About us  |  Disclaimer  |  Terms & Conditions  |  Privacy Policy  |  Content Accreditation
 RSS  |  News for my Website  |  Free news search widget  |  Help  |  Contact us  |  DMCA / Content Removal
How are we doing? Send us your feedback  |   LIKE us on Facebook   FOLLOW us on Twitter