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A Medical Device Clinical Auditor’s Favorite Regulation: 21 CR 812.100

A Medical Device Clinical Auditor%27s Favorite Regulations

I am often asked by industry colleagues that if I had to pick just one “favorite” federal regulation what would it be?  The answer is easily 21 CFR 812.100, as this regulation embodies 95% of the investigational site non-compliances  I observe as I conduct clinical investigator audits. Let me elaborate.

CEC and DSMB: What’s the Difference?

CEC and DSMB   What’s the Difference

Medical device sponsors, according to 21 CFR 812.40 and 812.46, are responsible for monitoring clinical trials.  The regulations require that sponsors monitor a trial at a site by ensuring that an investigator is compliant with the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth in the approval of the study by the IRB.  It is also the responsibility of the sponsor, according to 21 CFR 812.43(d) to select monitors qualified by training and experience to monitor a study in accordance with 812 and other applicable FDA regulations. Sponsors may also appoint other individuals and groups to ensure compliance and proper clinical trial monitoring as well as evaluate the accumulating outcome data. The FDA guidance, The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors, defines a Data Monitoring Committee (DMC), also knows as  Data Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs), as a group of individuals with pertinent expertise that reviews, on a regular basis, data from one or more ongoing clinical trials. Additionally, DMCs:

3 Costly Traps on the Road to Device Innovation

3 Costly Traps on the Road to Device Innovation

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.

More Innovative Med Tech

More Innovative Med Tech

According to an August 22nd article in FierceMedicalDevices the FDA has picked up the pace on the most novel medical devices, but this year might not match levels seen in 2011 and 2012.  To highlight this point, the article points out the agency granted 17 premarket approvals, which is a marked increase over the 23 granted for the entirety of 2013.

Cell Therapy: The Fourth Pillar of HealthCare

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As the cell therapy market continues to grow, it’s important to note the similarities between medical device and cell therapy clinical trials. To help illustrate this, we’ve created an infographic, “Cell Therapy: The Fourth Pillar of Healthcare,” which is available for download.

“If it is not documented, it was not done”

Documentation in Clinical Research

In clinical research this phrase is used to emphasize the importance of complete and accurate documentation to site staff.  Still, every year we see that FDA issues multiple warning letters which cite, “You failed to maintain adequate and accurate records.”

1937 – Elixir Sulfanilamide

Elixir Sulfanilamide Disaster

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an eBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014 calendar year.

Research Awareness and Participation Barriers

Research Awareness and Participation Barriers

An article was recently published in the Clinical Researcher entitled “Increasing Provider Engagement in Clinical Research Starts with Research Awareness:  Leveraging Education and Technology to Improve Participation”.  In this article, the authors indicated that whether directly or indirectly involved with clinical trials, increasing research awareness may increase health outcomes, study accrual, and patient safety.  Subsequently, the ability to enroll in a clinical research trial may improve patient care for some individuals and result in better outcomes for future patients.  Without increasing accrual, sites and sponsors are not able to efficiently conduct clinical trials.

Compassionate Use and the Animal Rule

Compassionate Use and the Animal Rule

In March of 2014, we wrote about Compassionate use in Unapproved Medical Devices. To briefly summarize, compassionate use refers to the use of an unapproved device or drug in a single patient or small group where the condition of the patient/group is serious and there is no alternative treatment. The FDA can use regulatory discretion to determine if an investigational drug/device can be used and FDA approval is required prior to use.  This clause has come under the spotlight recently with the treatment of two American health care workers and a Spanish priest with an experimental drug, ZMapp, developed by the pharmaceutical company MAPP Pharmaceuticals. ZMapp is a serum-based drug that previously had not been clinically tested in humans.  It represents a number of drugs and vaccines that are currently being developed  to combat Ebola, a single-stranded RNA virus that is highly pathogenic with a fatality rate of up to 90%. According to the World Health Organization, as of 16 August 2014 there have been 2240 reported cases and 1229 deaths from this disease spanning four countries in West Africa (Guinea, Liberia, Sierra Leone, and Nigeria).

Understanding the Difference Between FDA Regulations and ISO 14155

Understanding the Difference Between FDA Regulations and ISO 14155

As industry begins conducting more and more device trials globally, now more than ever it is crucial to understand the important differences that exist between the FDA’s regulations and the international standards of ISO 14155.  IMARC Research has created a new whitepaper that highlights these differences.

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