FDA regulation on medical device packaging design

FDA regulation on medical device packaging design is only a set or regulations that require adherence to the device packaging design elements.

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The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”

Does this mean that the FDA regulation on medical device packaging design is simple, plain and broad, and can be bypassed? Not really. Compliance with the medical device packaging design has to be seen in relation to two factors:

Medical Device 3

Sits with device labeling requirements

FDA regulation on medical device packaging design has to be seen in conjunction with its twin regulation, namely Sec. 820.120 device labeling. This is the first of the two sections on medical device labeling and packaging. This section has elaborate details on how medical devices need to be packaged and labeled. The FDA has requirements in this section on the integrity, inspection, storage, operations, and control number of labeling. FDA regulation on medical device packaging design has to be complied with collectively with this section.

Scope for creativitySecondly, FDA regulation on medical device packaging design is only a set or regulations that require adherence to the device packaging design elements. Medical device packaging design manufacturers are free to use their creativity in designing device packaging. Adherence to FDA regulation on medical device packaging design does not mean that there should be no innovation; it only means that the medical device packaging design has to be complied with. As long as this is met, manufacturers are free to design imaginatively. Perhaps because there is enough scope for innovation, FDA has left this area general and nonspecific, with the only requirements being that the medical device packaging design adhere to guidelines aimed at protecting it.

Author: compliance4all

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits. Industries We Focus On: • Trade & Logistics • Aerospace Defense • Banking & Insurance • Food & Beverages • Auditing/Accounting & Tax • Energy • Environment • Education • Automotive Transport • Science and Technology • Government • Construction • Electronics & Semiconductor • Operation • Engineering/Science • Purchasing & Vendor Relation • General counsel/Accountant • Geology & Mining • Documentation/Records

5 thoughts on “FDA regulation on medical device packaging design”

  1. So in saying this you are stating that as long as procedures of labeling and packaging requirements are met the rules are a basis to allow imagination when it comes to how the product is seen and delivered maintains no damage and no labeling errors that would otherwise become a problematic thing if the product had such issues

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