(FDANews: Falls Church, VA) -- FDAnews has announced details for its 7th Annual Medical Device Quality Congress to be held June 2–4 in Bethesda, Maryland.

Changes affecting medical device firms in 2010

The year 2010 has begun with a bang. A new director at the Center for Devices and Radiological Health (CDRH), changes in recall requirements under the “corrective fix” pilot program, upcoming postmarket surveillance initiatives, the difficult 15-day deadline for responding to 483s, steps to improve the quality of clinical data that support premarket approval applications, revisions to the 510(k) clearance process, and more.

With a start to the year like this, what will the rest of 2010 hold for medical device companies?

That’s not easily or quickly answered—but there are experienced experts and top-ranking FDA officials to contact for keeping in-the-know and up-to-date on all the critical issues that may concern you and your company this year, going right through to Dec. 31.

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