May 2011 Posts

A New Focus on Information Security

According to the FCC, American small businesses lose billions to cyber attacks annually, and 74 percent of small and medium businesses reported being affected by cyber attacks in the past 12 months. The average cost of these attacks for business, per incident, was $188,242. The most important step your company can take is securing your data. This is not only a good idea financially, but also from a legal and regulatory standpoint. (more…)

Impact of the New 510(k)/PMA Process on Companies for Quality Management

The entire medical device community is waiting patiently to see how the U.S. Food and Drug Administration changes the 510(k) clearance process. In January 2011, the Agency announced a plan containing 25 actions it intends to implement during the year to improve the most common path to market for medical devices.

According to a press release, the FDA’s key actions include:

  • Streamlining the “de novo” review process for certain innovative, lower-risk medical devices
  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making