A brief look into the nature of FDA medical device GMP guidelines

Key Takeaway:

The FDA’s guidelines on medical devices GMP regulations are broad and flexible. The onus of proving compliance with the guidelines in accordance with appropriate sections of part 820 lies with the manufacturer.

The FDA has issued Good Manufacturing Guidelines for medical devices. This is necessary since medical devices constitute one of the major areas of FDA regulation. The preamble of FDA’s Quality System (QS) regulation or what it calls the Medical Device Good Manufacturing Practices states that “Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications”.

Quality Systems for medical devices are known as Current Good Manufacturing Practices (cGMPs) and are codified under part 820. They are currently bunched together along with the following:

  • Foods
  • Drugs, and
  • Biologicals

Broad and flexible guidelines

The QS regulation for FDA Medical Device GMP Guidelines follows what is called an “umbrella” approach to the cGMP regulation. What this means is that a broad set of regulations applies to a variety of medical devices. The reasoning for this approach is that the regulation must apply to several different types of devices. This being the case, it is almost impossible to prescribe cGMP regulations for each of these, as each manufacturer will have unique aspects built into a device it manufactures.

In essence, we can understand the core of FDA Medical Device GMP Guidelines to mean the


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