BTRA641 Product Life Cycle, considering a product defect

BTRA 641 University of Maryland Product Life Cycle Discussion

1) For this week’s writing assignment, you will be considering a product defect that trigger a product recall. Write a one to two page essay of a Medical Device Reporting (MDR) that is typically included in a product recall process.

2) What is the process/timeline from submission of an application for a medical device to a decision by the FDA? How does this process differ from drugs/biologics?

3) What regulatory authority does the FDA currently have over the design of medical devices?

4) Although Nanotechnology has been with us for some time (review the following: Nanotechnology application ) it is likely that its impact on our society are yet to be fully felt. However, the impact is likely to be particularly significant in industry at large as well as in the practice of medicine. Read a recent Sciencexpress paper by N. Korin et al provided in this week's course content for a cardiovascular application example. This week's material points toward efforts on the part of Government to prepare for these impacts including some prodding for action by Congress http://www.newhavenindependent.org/index.php/archives/entry/congress_to_fda_study_nano_safety/id_48449

. Comment on whether you think the Government is prepared to handle these changes (changes brought on by new technologies such as nanotechnology) and if not, what other actions should be explored. In particular consider the regulatory provisions in place now - are they adequate?

5) One of the challenges the FDA has had to confront in recent years is how to adequately oversee the quality in the manufacturing facilities in foreign countries where larger amounts of products are coming into the US. Take a look at the following: FDA MOUs and other international arrangements and address the following:

Given the diversity in Regulations in the foreign countries, how might increased US involvement in ICH activities help alleviate some of the product quality occasionally observed in products entering the US market? In addition to material provided in the Course content area for this week, include material from the above link.