SUBSCRIPTION

Medical Devices Law & Industry Report

Medical Devices Law & Industry Report provides complete in-depth, interdisciplinary news coverage of all major developments in the rapidly changing medical devices industry.

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OVERVIEW

EXPERT NEWS & COMMENTARY

Get the latest in-depth reporting on regulatory, legislative, legal, and industry issues affecting the medical-device product lifecycle.


TRUSTED LEGAL ANALYSIS

Gain insights from practicing attorneys, government officials, and industry experts analyzing the latest FDA regulations, guidelines, and practices. Up-to-date information on Medicare program changes, industry mergers and acquisitions, and federal and state legislation affecting sales and regulation of medical devices.

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POWERFUL RESEARCH FEATURES

Have the information you need to support your involvement in the medical device industry as an attorney, manufacturer, regulator, or investor, safeguarding your interests and those of your company and clients. Track federal enforcement actions taken against medical device companies by the FDA, Department of Justice, and Federal Trade Commission, including fraud and abuse and antitrust claims.


TOPICS COVERED

  • Adverse event reporting
  • Advertising and promotion
  • Antitrust
  • Compliance
  • Cost containment
  • Coverage and reimbursement policies
  • Diagnostic equipment
  • Fraud and abuse
  • Group purchasing organizations
  • Industry standards
  • International regulation
  • Joint ventures
  • Manufacturing practices
  • Mergers and acquisitions
  • Off-label use
  • Postmarket safety review
  • Product liability
  • Quality control
  • Safety
  • Unique device identifiers
  • User fees
Key Laws and Regulations
  • FDA Safety and Innovation Act of 2012
  • Food, Drug, and Cosmetic Act
  • Medical Device Amendments
  • Medical Device User Fee Act
  • Medical Device User Fee Stabilization Act of 2005

SPECIFICATIONS

Product Structure

Notification: current reports providing news and developments.

Formats and Frequency

Web notification issued and available continually.