Medtech companies in the U.S. are concerned about Chinese device manufacturers stealing their intellectual property and making knock-offs that replicate American devices.  However, these devices are not as safe according to Advamed.

The area of combination products is an exciting expanse of potential innovation and discovery for both the medical device and drug industries. But what exactly are combination products? According to 21 CFR 3.2(e), they are defined as:

According to an article in “The Gray Sheet” the FDA is proposing new regulatory language to determine what devices designated Class III devices and not suitable for down-classification.

It just depends!

The FDA is sticking with the foundation of its 1997 Guidance on 501(k) device modifications, with plans that follow device industry feedback, according to an article in The Gray Sheet.  In a report submitted to Congress, the 1997 guidance is a “solid foundation and should remain mostly unchanged.”

Recently, a team of IMARC monitors traveled to a sponsor’s clinical research headquarters to meet face-to-face, study team to study team, to kick off a new medical device study. The two teams joined together with a heavy agenda to get the study’s ducks in a row prior to our monitors hitting the road for the on-site initiation visits scheduled in the upcoming weeks. While this is not always the case at study start-up, with tight timelines and limited budgets, there are many advantages to getting the teams together at the beginning of the study to help prepare for a successful study. Additionally, the teams can process through potential study challenges before they become potentially larger issues. Read on to learn five reasons why the sponsor should meet with and include the CRO in study start up!

On April 30, 2013, FDA announced a workshop titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” scheduled for June 13, 2013. The main purpose of the meeting is to discuss the agency’s past, present, and future policy on 510(k) modifications. The FDA is inviting external stakeholders to provide discussion and bring examples of actual device modifications to use in developing future policy.

Recently launched,  aptitude's online marketplace main goal is to connect medical device suppliers with device purchasers.  In an article posted on MassDevice.com, aptitude’s Vice President and General Manager described it as being, “like eBay, which provides a marketplace where buyers and sellers can come together."

FDA is currently seeking comments on the collection of information regarding the Humanitarian Device Exemption (HDE) applications and related requirements. As summarized by an article in MassDevice, the FDA is interested in learning:

With the trials IMARC Research has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device. However, on one of the projects we were working on FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted.