Online Safety Community

FDA regulation on medical device packaging design

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.

Views: 14


You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Jam Blanco posted a blog post

Appropriate Safety Masks to Use to Avoid Inhaling Asbestos

Workers from practically all trades, from factory workers to roofers, carpenters, auto mechanics, plumbers, and others are in danger of being exposed to asbestos on the job. Studies prove that individuals…See More
9 hours ago
Adam Fleaming posted a blog post

Virtual healthcare has to be understood and used for what it can offer

Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual technology has also been in widespread…See More
15 hours ago
Mark Nilson posted events
16 hours ago
John Robinson posted events
17 hours ago


Understanding Data Parallelism in MapReduce

In order to understand the goals of MapReduce, it is important to realize for which scenarios MapReduce is optimized. The MapReduce programming model is created for processing data which requires…Continue

Tags: program, Implementation, Mapreduce

Started by gracylayla Mar 14.

Automation Anywhere. How do I pick a value from dropdown

Automation Anywhere. How do I pick a value from dropdown. I tried 'set text' from a copied variable. Its very slow, and also doesnt…Continue

Tags: anywhere, automation

Started by emmablisa Mar 9.

TensorFlow serving vs TensorFlow service

I have a question regarding the difference between TensorFlow Serving versus TensorFlow service. (Sorry that I'm not familiar with this at all.)I found TensorFlow serving's definition, which is "…Continue

Tags: training, online, tensorflow

Started by emmablisa Feb 27.

Proper maintenance for Hi Vis clothing

Can you tell me how to properly take care of Hi Vis jackets? I recently purchased a few ones from this…Continue

Started by Lily Osborn Feb 25.

Forklift Operator Requirements 1 Reply

At our company we have a lot of forklift traffic that has to share the same aisles as our pedestrians. We limit the speed of our lifts to 3 mph.  I am wanting to find out what requirements for…Continue

Started by Rick Briggs. Last reply by Tony Ferraro Feb 25.



© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service