It’s pretty well known that the FDA has responsibility for enforcing a broad range of statutory and regulatory requirements. Did you know Regulatory responsibility also carries over to one of the offices under the Executive Office of the President? This office is the Office of Information and Regulatory Affairs (OIRA). According to the website the office carries out several important functions, including reviewing Federal Regulations, reducing paperwork burdens, and overseeing policies relating to privacy, information quality, and statistical programs.

The new 510(k) guidelines released by the FDA aim to provide transparency and predictability for companies that are seeking lower-risk device approval through the 510(k) pathway.  Since the initial draft guidance was released, critics have argued that these proposed changes could negatively impact industry, raising the R&D costs to bring a non-significant risk device to market and potentially pushing jobs out of the US as companies strategically look for less cumbersome routes of approval. With the release of the official less cumbersome guidelines, new critics have emerged, stating that the American public ends up the big loser due to the concessions that the FDA made, purportedly as a result of pressures from Congress and industry.

With the economy the way it is “budget” is a word on everyone’s mind- including those in the medical device industry. It has been discussed that the US might be taking a back seat in the medical technology market because of financing and economic challenges. With these concerns in the back of everyone’s mind a recent article on MD+DI caught my attention. This piece highlights these issues and focuses on cost saving strategies for device startups.

“You do a really good job with complex trials.” 

We're lucky to say that we’ve heard this from several clients over the years. But, while we’re glad for the recognition, it made us ask ourselves a key question. What is it that makes a trial complex?

The NY Daily News recently published an article which suggests that our industry is falling short in the realm of clinical trials. The article focuses on a report from the Journal of the American Medical Association that was conducted by the FDA and top leaders at Duke University. The objective, as stated in the abstract, was to “examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.”

For a sponsor or investigator, selecting the right Clinical Research Organization (CRO) to help with the monitoring and management of a clinical trial can be crucial to a successful outcome.

The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.

Oftentimes when one thinks of clinical trial monitoring, he thinks of a monitor making periodic site visits to the hospital or institution where the trial is taking place.  During these visits, the monitor verifies the data collected with the site’s source data and study documentation, among other duties.  These periodic site visits are often scheduled and made on an elapsed duration.  For example, some sponsors/studies require a monitor to be on site every 4-6 weeks to keep tabs on the data.  Seems like a pretty straightforward, streamlined, routine process, right?

In late April a bill was to congress by a group of bipartisan Senators: Claire McCaskill, Susan Collins, and Tom Coburn.  This bill, “Plain Writing Act for Regulations of 2012,” hopes to accomplish just what the title indicates- require the regulations use plain writing to increase public understanding and participation in the process. What is plain language? A quick internet search yielded this government definition, “communication your audience can understand the first time they read or hear it. Language that is plain to one set of readers may not be plain to others.”

This recent article from MedCity News caught my eye.  The article states that the medical device industry is rallying around the repeal of the 2.3% medical device tax as a job and innovation killer.  However, they indicate that a potentially bigger threat to the medical device industry is the strong health and wellness push that is focused on keeping patients out of the hospital.