Swamped with your writing assignments? Take the weight off your shoulder!
For this assignment, you are a Regulatory Affairs Officer for a medical device company, Acme Medical Device Corporation. Your company has developed a new delivery method for vaccines called a vaccine patch. This product is designed to provide an easier and more convenient method of delivering a vaccine as opposed to a typical injection using a syringe. This medical device for delivery of the vaccine in a patch form was initially approved for use by the FDA in 1999. However, your company discovered that the original design of the patch was somewhat flawed. The adhesive used to keep the patch in place is not as strong as previously thought. Since the patch must remain in place for 24 hours, it is imperative that this adhesive work well. So, your company decides to investigate alternative adhesives to use in the next design phase. Ultimately, a new adhesive is discovered and it shows a greater level of efficacy for the vaccine patch since the patch is staying in place for the required 24 hours. Now, as the Regulatory Affairs Officer for Acme Medical Device Corporation, you much determine if a 510(k) needs to be filed for the modification of the vaccine patch. Do you need to file a 510(k) for this modification? Why or why not? Further describe what is required in a 510(k) application if you determine your modifications to the vaccine patch warrant a submission.