What this service is:

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

What it helps you do:

• Understand the diverse regulatory, legislative, legal, and industry issues that arise over the course of a medical device’s product lifecycle.
• Stay up to date on Food and Drug Administration regulation of medical devices, including clinical trials, postmarket safety review, recalls, oversight of manufacturing practices, and advertising guidelines.
• Be aware of changes in Medicare program coverage and reimbursement policies.
• Monitor federal and major state legislation and regulations affecting the sale of medical devices.
• Follow significant litigation involving medical devices, including product liability lawsuits and patent disputes.
• 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.
• Get the latest news from industry, from approvals of new devices, to mergers and acquisitions, to cost containment efforts by hospitals and health insurers.
• Gain insights from Analysis & Perspective articles by practicing attorneys, government officials, and industry experts.
• 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.

Product Structure

Notification: current reports providing news and developments

Formats and Frequency

Print and Web notification formats are issued and available biweekly.

• Adverse event reporting
• Advertising and promotion
• Antitrust
• Approvals
• Bioethics
• Centers for Medicare & Medicaid Services
• Classification
• Clinical trials
• Communications technology
• Compliance
• Cost containment
• Coverage and reimbursement policies
• Diagnostic equipment
• Federal Trade Commission
• Food and Drug Administration
• Food, Drug, and Cosmetic Act
• Fraud and abuse
• Gainsharing arrangements
• Group purchasing organizations
• Hospitals
• Implants
• Industry standards
• Information technology
• Instruments
• Insurers
• Intellectual property
• International regulation
• Investment capital
• Joint ventures
• Manufacturing practices
• Medicare
• Mergers and acquisitions
• Off-label use
• Patent infringement litigation
• Postmarket safety review
• Pricing
• Pediatric safety and review
• Product liability
• Public policy
• Quality control
• Recalls
• Sales and marketing
• Securities
• User fees