Healthcare Law

Developers and manufacturers of medical devices need to understand 510 (k) approval of medical devices and other FDA compliance issues.

Developers and manufacturers of medical devices need to understand how FDA classifies the devices and the criteria for approval

Managed Service Organizations Can Help Medical Practices Comply with Stark Law, the Anti-Kickback Statute (AKS), and Corporate Practice of Medicine Laws

Developers and manufacturers of stem cell therapies need to understand how to conduct clinical trials in order to process FDA investigational new drug (IND) applications.

A MSO helps separate the medical side of a med spa from the business side of the med spa. A properly drafted MSA helps clarify the roles of the MSO and federal and state compliance issues.

The FDA’s Center for Biologics Evaluation and Research (CBER) regulates stem cell products. Stem cells normally require an investigational new drug application.

An update of California’s new laws such as AB 2178 that address many licensing, treatment, practice, and do’s and don’ts of the medical profession.

California’s new electronic prescription law and other electronic prescription laws for healthcare providers and pharmacies.

California AB-890 authorizes two categories of nurse practitioners who can practice without physician supervision if specific criteria are met.

How the passage of SB 994 and AB 2685 affect the ability of naturopathic doctors to practice medicine and hire LVNs.