open access: Regulation of Medical Devices in the United States and European Union — NEJM (comparing differences pro's/con's)

Conclusions

Systems for approving new medical devices must provide pathways to market for important innovations while also ensuring that patients are adequately protected. To achieve these goals, the United States and European Union use a combination of premarket testing and postmarket vigilance but with some marked contrasts in their approaches. Features of both environments require reform, as well as continuing research to assess policy changes.

Study Calls Approval Process for Medical Devices Flawed - NYTimes.com

Abstract: Persistent Noncompliance With the Work-Hour Regulation (patient safety)

Note:
the Transportation Industry has been dealing with 'hours of service'
issues for decades    (same issues/different industry - fatigue)

 NOTE: A new Hours-of-Service (HOS) Proposed Rulemaking was published
on December 29, 2010. For details, visit the HOS Proposed Rule page to view the complete rulemaking, summary of changes, FAQs, and other related information.

Are we keeping research participants safe enough? Canadian Medical Association Journal - Editorial

"There is no question that research participants need protection. But regulations have grown so burdensome that they are overwhelming the very things they are meant to support and safeguard. Consequently, clinical research has been substantially decreased among industrialized countries."

Genetic Tests and FDA (U.S.)

FDA will convene a public meeting next week to hear from companies that make direct-to-consumer genetic tests, before it begins an overhaul of its regulations on genetic diagnostic testing,