
Life Science and Medical Devices
A regulatory lawyer or a life science lawyer can help you understand the appropriate classification and controls for your product or device.
Life Science and Medical Device Attorneys in Kalamazoo
The Food and Drug Administration works hard to establish guidelines for life science products, ensuring that products are safe and effective. Medical devices are classified according to (3) three classes based on (16) sixteen medical specialties. All such classifications are based on the intended use of the device and indications for use in the market. Class I devices present the lowest risk to patients; on the other hand, Class III devices present the greatest risk.
A medical device lawyer can help you understand the regulatory path for your product. 21 C.F.R. § 820 and 21 C.F.R. § 801 (CGMP’s and Labeling), in addition to others, are important guidelines that developers, manufacturing partners, labeling partners, and other participants in the supply chain must consider. Contacting a medical device lawyer is a smart way to learn more about the appropriate regulatory path so you can offer your idea, your product, in a safe and effective manner.
Getting Started – Medical Device Lawyer
The first challenge for a new medical device company or a medical device entrepreneur is knowing where to start. All medical devices are controlled by the general controls of the Federal Food Drug & Cosmetic (FD&C) Act, which contain the final procedural regulations in Title 21 of the Code of Federal Regulations, Part 800-1200 (21 CFR § Parts 800 – 12993). The aforement