FDA (The Food and Drug Administration) is an agency within the Department of Health and Human Services and consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices.

FDA 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 food supply, cosmetics, and products that emit radiation.

FDA ensures the safety of:

• all food except for meat, poultry and some egg products
• all drugs, biological products (including blood, vaccines and tissues for transplantation)
• medical devices
• animal drugs and feed
• and makes sure that cosmetics and medical and consumer products that emit radiation do no harm.

How is obligation of manufacturers

Determine if your product is regulated by FDA and subject to FDA regulation

Find out the requirement you should comply depend on product.

Steps to follow FDA guidance to your medical device:

• Classify your product
• Register and list
• Label a device
• Medical Device Reporting (MDR): How to report medical device problems
• Study and market your device
• Find device approvals and clearances

FDA may conduct an inspection of your operation for a variety of reasons, such as a routinely scheduled investigation, a survey, or a response to a reported problem.

TADcom support Manufacturer of medical device to comply with FDA requirement in:

Read more:

- 510(k) registration