R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

What You Should Do About the Two New FDA Draft Guidance Documents

It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.

Industry Advice: Earn RAC Points and Enhance Your Resume by Writing for RAPS' Regulatory Focus

You've already read a few benefits in the title but let's reiterate:

  • Earn RAC points
  • Enhance your resume/LinkedIn profile
  • Get published, and share your expertise with industry peers in the process

These are just three of the several reasons you should consider writing an article for RAPS' Regulatory Focus.

Don't sweat it if writing isn't your forte - there's nothing to be afraid of. The editorial board is there to you help you bring your ideas to life (and correct all those grammatical and punctuation errors). And once you get started, the entire writing process usually takes less time than you think. RAPS is looking for authors for the September and October 2016 issues of Regulatory FocusOr... maybe you have an idea for an article that could appear in any issue? Either way, now is your chance and here are more specific details.

Regulatory Intel - Jan. 14, 2013 Quick-Hits

A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:

Mobile Medical Applications: Falling Star?

I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.

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