I would further like to continue this topic by asking what types of marketing applications are required for a combination product?

Combination products are assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation. Consistent with section 503(g)(1) of the Act, assignment to a center with...

I agree with all the points that Devarshi has made and would also like to add that Solid Design Inputs makes the rest of medical device product development easier too. Once Design Inputs are defined, ...

In the final semester of my undergrad we were required to work on a project that would be equivalent to the capstone project here in NJIT. Each team was assigned an Internal guide who would help us pl...

The objective of ECOs and any other change orders is to legitimately archive the proposed changes for tracebility purposes. Any necessary changes of the design or documentation go through COs. The COs...

A product risk can occur due to a defect in the drug release mechanism in a drug delivering device. Under FMEA a drug delivering device would be a Concept Design / Hardware risk where the probability...

That is an interesting topic. Medical Devices are categorized based on the risk associated with the usage of the device. The categorization is based on different parameters such as 1. The general regu...

As well know, all medical devices require approval so that they can be used. What do you think happens in the case of an emergency? Can a physician use an unapproved device, if it has the potential to...

According to me, the first, and most critical, step to initiate a project is defining the extent of the project. What is it you should achieve or make? What is the task objective? Similarly important ...

I agree with all the comments made here, and would like to add mah52's plastic syringe example that as plastic is chemically inert, use of a different grade plastic material would not require a PMA. A...

We're full of ideas of what would make the best business plan and are convinced that it will earn us plenty of money. To convert these ideas into words and convince investors to see the success of thi...

I would like to work in a matrix based organization. I agree with the points made by smitshah and srg36. I would like to add this type of organization will result in good management of resources, it e...

The Food and Drug Administration (FDA) is amending its combination product regulations to define “mode of action” (MOA) and “primary mode of action” (PMOA). Where, MOA is the means by which a therape...

I took Dr Collins class "Biomaterials" last spring, and this discussion took me back to a discussion we had in class about the Global Regulatory Environment. The FDA has very stringent rules, that the...

In my opinion the Fitbit should be classified as a Class 1 device as similar device exist in the market. This will help decrease the testing period as their are similar devices that prove that such de...