Medical Device and Pharmaceuticals Regulatory Affairs and Quality Consulting for the United States
The United States has the biggest healthcare industry in the world, spending approximately $3 trillion a year. By 2018, healthcare will comprise close to 18% US gross domestic product – a sizable market opportunity for a new generation of entrepreneurs selling innovations to the industry, the government, and increasingly directly to consumers.
|USA Medical Device Market Size||USA Pharmaceutical Market Size|
|$125.4 billion||$425 billion|
|Projected Growth Rate: 6.1%||Projected Growth Rate: 5.6%|
|USA Economic Indicators|
|GDP (PPP): $18.588 trillion|
|Per Capita GDP (PPP): $57, 220|
|Real GDP Growth Rate: 2.7%|
|Population (millions): 325.14|
|Ethnic Diversity: 72.14% White, 4.8% Asians, 9.1% Multiracial|
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
FDA regulates the products through different offices:
- Office of Medical Products and Tobacco
- Center for Biologics Evaluation and Research
- Center for Devices and Radiological Health
- Center for Drug Evaluation and Research
- Center for Tobacco Products
- Office of Special Medical Programs
- Oncology Center of Excellence
For more information about the FDA, visit http://www.fda.gov/