Category Archives: 510(k)

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

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 sizes spent in the pre-IDE process. Continue reading

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

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. Continue reading

Top 30 FDA Stories | 2Q 2011

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

  1. The Drug Shortage:  Some people say the FDA is inadvertently at fault.  Some say the FDA prevented 38 close calls. Some say that the shortage is a niche business opportunity.  There was also some chatter that the FTC take these drug shortages into account when looking at M&A.
  2. The Avastin Battle: back and forth, back and forth, the FDA and Roche have gone. Finally last week, the FDA rejected arguments from Roche/Genentech that its approved anti-cancer drug  should continue as an approved therapy for advanced breast cancer.  Now that the science round is over, let the politics round begin.
  3. The other Triad/H&P Industries shoe drops. The big MSNBC lead story in February was just the beginning.  Here’s a good background post by PharmaLot.  And finally, in June, the FDA issued the consent decree. Continue reading

Top 5 Info Sources for Medical Device Manufacturers

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 it comes to the reliability and accuracy of what is being presented as fact. Continue reading

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

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 in order to preserve America’s ability to maintain an innovation and manufacturing lead in the industry. Continue reading

New MDDS Final Rule Offers Class I Status For Off-The-Shelf 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. Continue reading

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

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 might analyze the information and cut significant time from their own research and development in the same areas. Continue reading

FDA De Novo Process 101 For 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 device manufacturers.  It’s not as easy as it seems. Continue reading