510k Posts

Five Years, Twenty-Six Days

Five Years, Twenty-Six Days

Mark Crawford

On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. (more…)

FDA Seeks to Standardize Electronic Data Submittals

Mark Crawford

In February the FDA released a guidance document proposing a standardized format for submitting clinical and nonclinical data to the agency. The FDA maintains that by following this protocol early in the product development cycle medical device and pharmaceutical companies can reduce bottlenecks and speed up the approval process. (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

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