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FDA releases CDRH action plan for 510(k) and science initiatives

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 24 2011

On January 19, 2011, the US Food and Drug Administration (FDA) released a plan for 2011 involving 25 action steps to improve the most common regulatory-approval path for medical devices, the 510(k) process

FDA’s medical device review process: 510(k) premarket notification process scrutinized

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • November 5 2010

As many know, on August 3, 2010, the Food and Drug Administration (FDA) released proposed reforms to the 510(k) premarket notification program

FDA and CMS announce intention to collaborate in two major areas

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 6 2010

All companies within the health care industry should be aware of two recent developments in the area of medical device approval and federal health care program reimbursement

Proposed modifications to HIPAA’s Privacy, Security, and Enforcement Rules

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • September 10 2010

On July 14, 2010, the Office for Civil Rights (OCR) under the Department of Health and Human Services published proposed regulations intended to implement the statutory changes made to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as provided by the Health Information Technology for Economic and Clinical Health (HITECH) Act