510(k)

//510(k)
13 10, 2011

Smaller Medical Device Companies Facing Extended 510(k) Review Periods

By | 2016-07-12T15:52:58+00:00 October 13th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

Smaller medical device companies aren’t imagining things – it really does take longer to receive 510(k) approval for medical device developers with fewer than 100 employees than it does for larger industry players.  This startling information comes from a study published this summer by researchers at Northwestern University, which took a hard look at how much time companies of various [...]

18 08, 2011

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

By | 2016-07-12T16:08:58+00:00 August 18th, 2011|510(k), cGMP Quality Assurance and FDA 483s, FDA Enforcement News, Medical Devices|

Medical device companies operating in the in vitro diagnostic and radiology sectors of the industry received some surprising news this past month when it was revealed that the FDA had decided to relax certain regulatory requirements pertaining to these products.  Specifically, a number of device types will now be exempt from premarket notification requirements. […]

5 07, 2011

Top 30 FDA Stories | 2Q 2011

By | 2017-11-06T01:20:00+00:00 July 5th, 2011|510(k), Biopharma / Pharma, CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Consent Decree, FDA Enforcement News, Medical Devices|

The FDA is having a very busy year.  Q1 saw a slew of approvals, policy changes, high-profile stories, enforcement activities, and personnel changes.  Q2 was no different.  Here are our top 30 stories on the FDA for Q2 of 2011. The Big Stories of the Quarter The Drug Shortage:  Some people say the FDA is inadvertently at fault.  Some say [...]

9 06, 2011

Top 5 Info Sources for Medical Device Manufacturers

By | 2016-07-12T16:08:47+00:00 June 9th, 2011|510(k), cGMP Quality Assurance and FDA 483s, FDA, Medical Devices|

The Internet offers a seemingly unlimited information resource for medical device developers, allowing them to tap into regulatory information and guidance, market reports and consumer opinion, as well as in-depth coverage of the state of the industry as a whole. Unfortunately, the broad reach of the online world also means that not all news sources carry the same weight when [...]

6 06, 2011

Dr. Shuren of FDA responds to 510(k) Criticisms

By | 2016-07-12T16:02:49+00:00 June 6th, 2011|510(k), cGMP Quality Assurance and FDA 483s, FDA, Medical Devices|

In March, MDCI touched on the sentiment of several medical device industry players and members of the federal government that the FDA is taking too long to approve new products. This feeling was drawn into focus in a blog post by Rep. Joe Pitts on The Hill’s Congress Blog that asked the Administration to improve its time-to-market for medical devices [...]

19 05, 2011

New MDDS Final Rule Offers Class I Status For Off-The-Shelf Medical Devices

By | 2016-07-12T15:52:01+00:00 May 19th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

A new FDA final rule for Medical Device Data Systems (MDDS) went into effect this past month, with the intent of simplifying the regulations surrounding a significant portion of IT equipment and software used during the provision of health services. The key aspect of this new final rule is the reclassification of certain MDDS as Class I devices. […]

3 05, 2011

FDA May Make Failed Medical Device Info Available to the Public?

By | 2016-07-12T16:13:27+00:00 May 3rd, 2011|510(k), cGMP Quality Assurance and FDA 483s, FDA Enforcement News, Medical Devices|

Learning from the failures of others is one of the most basic building blocks of scientific discourse, and medical device companies may soon gain access to an important resource from the FDA that could offer substantial insight when it comes to device development. The Administration is considering making public files that describe failed medical devices and drugs so that companies [...]

7 04, 2011

FDA De Novo Process 101 For Medical Devices

By | 2017-06-30T12:44:56+00:00 April 7th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

One of the most frequent questions MDCI fields from new medical device companies relates to the FDA’s “De Novo” process.  In fact, they get so many inquiries about the De Novo process that they put together this post that addresses the history and function of the process and offers some guidance regarding its viability as path to market for medical [...]