The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.

What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?

On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.

No matter the therapeutic area, device companies agree: Creating cutting-edge products is expensive. From the R&D costs to the pricy FDA fees, the expense for innovation adds up quickly. As products become more technologically advanced, the cost for designing new devices has increased. At the same time, device companies are being hit with fees that are wiping out their R&D budgets, such as the 2.3% medical device tax, which reportedly requires companies to collectively pay an estimated $194 million per month.

Outcomes research can be defined as “the study of the end results of health services that takes patients' experiences, preferences, and values into account—is intended to provide scientific evidence relating to decisions made by all who participate in health care.” Recently, the push has been for greater emphasis on outcomes and a new joint effort is a giant boost in this direction.

The World Health Assembly is the decision-making body of the World Health Organization (WHO). This assembly draws leading government health officials from the 194 WHO member nations and was first convened in 1948 shortly after the WHO was created. On 24 May 2014, the 67th annual World Health Assembly closed.  This close marked the end to a five day meeting that featured a record-breaking number of agenda items, documents and resolutions, and almost 3,500 registered delegates. During the assembly more than 20 resolutions on important global public health issues were adopted.  These adoptions ranged from issues relating from antimicrobial drug resistance and access to essential medicines to addressing the global challenge of violence and the public impact of exposure to mercury and mercury compounds. Of note, is the passage of a resolution to strengthen regulatory systems.

When and how is compassionate use of unapproved medical devices allowed? The Federal Regulations explicitly state how an unapproved device should be used in a compassionate use situation by a physician. The FDA website also provides a training presentation on this topic.

In order for a new medical product to reach patients it must first be proven safe and effective and then be approved for use by the governing regulatory body. Clinical trials are the vehicle to bring these innovative technologies to patients and evaluate them in support of regulatory approval. Unless a product is approved under the appropriate regulations for a specific use, it cannot be commercialized for that indication. In clinical research the products are still investigational, and even in a hospital setting, these products are treated differently.

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:

The FDA is taking steps to jumpstart the development of medical devices for children through grants to non-profit organizations and research consortia.   The grants which total $18 million were announced by the agency on September 25th.