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Regulatory & FDA Law

FDA cartoon

The FDA places heavy regulatory burdens on medical device manufacturers and pharma.  Dr. Teitel has broad experience with medical devices from medical, legal, and regulatory viewpoints.  His experience spans Class II medical devices, including diagnostics, as well as Class III implantables.  Whether developing a regulatory strategy for a start-up or early-stage company, updating an established regulatory plan, or designing clinical trials to support FDA submissions, Dr. Teitel’s experience can help.  He also has experience with Health Hazard Evaluations, product recalls and assisting management with their FDA interactions, including meetings at the FDA.  Having been a Chief Medical Officer in industry and a medical device company CEO, in addition to being an end user of devices as a practicing surgeon, he has a unique understanding of how regulatory issues affect a medical device company’s operations and bottom line.

An international regulatory strategy is more than just a “mini-FDA” plan.  Many counties have differing regulatory pathways.  Therefore, it’s important to develop a global regulatory strategy when mapping out a medical product’s regulatory plan that includes international markets.

Dr. Teitel and The Teitel Firm stand ready to assist on all regulatory and FDA matters.

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Latest News

  • 10 New Malpractice Concerns, and How to Avoid Them
  • Surviving a Medical Board Investigation
  • Repeal of medical device tax could spell relief for Houston companies
  • AdvaMed 2010 Conference

Emerging Legal Issues

Emergency Departments Still Overcharging Patients, Lawsuit Filed

Nashville, TN There was a flurry of reports and studies about five years ago that found routine price gouging in emergency rooms nationwide, and it was worse for the most vulnerable populations – poor [...]

Attorney Discusses Camp Lejeune Contaminated Water Lawsuits

Garden City, NY “Attorneys have been lobbying many years for the Camp Lejeune Justice Act and now we see an opportunity for justice, an opportunity for victims to file a Camp Lejeune lawsuit,” says at [...]

MLB To Pay $185 million “Starvation Deal”

San Francisco, CA Minor league ballplayers asked a California federal judge last month to approve a $185 million settlement they reached with Major League Baseball over alleged "starvation" [...]

DOJ says No-Poach Agreements Illegal

Los Angeles, CA Weighing in on a California labor lawsuit filed by truckers against trucking companies, the U.S. Department of Justice (DOJ) said that competing employers’ no-poach agreements are inhe [...]

United Airlines Appears to Stiff Early Retirees

Chicago, IL Cast your mind back to 2020. We were staying at home, fully masked, wearing blue gloves, bleaching our kitchen counters and very worried about people living in congregate settings, like nu [...]

Dr. Teitel’s Blog Posts

10 New Malpractice Concerns, and How to Avoid Them

This is a good summary of risks to doctors posed by new healthcare paradigms.  It outlines risks caused by social media, smart phones, team based medicine hospital based doctors instead of patients’ … [Read More...]

Surviving a Medical Board Investigation

Here is a good article that explains how trying to handle issues with your Medical Board or Credentials Committee without the help of a health care lawyer who understands your rights, empathizes with … [Read More...]

Repeal of medical device tax could spell relief for Houston companies

Some Houston companies may be holding their breath after the Senate voted last week to repeal the 2.3 percent excise tax on medical devices. The medical device tax went into effect in January and has … [Read More...]

AdvaMed 2010 Conference

Go to "The Changing Face of Medical Technology Innovation." … [Read More...]

Hot Legal Issues

Possible Lawsuit: Camp LeJeune Water Contamination

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Possible Lawsuit: Qui Tam Whistleblower

alleging fraud against the government reported by an individual acting as a government whistleblower. [...]

Law Suit Filed: Overtime, CA

California, you may be entitled to overtime wages [...]

Possible Lawsuit: Emergency Room Charges

alleging hospital overcharging and hidden fees on emergency room bills. [...]

Possible Lawsuit: Defective Product

alleging personal injuries caused by defective products. [...]

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