Medical Device CRO Blog

FDA defines the term laboratory developed test (LDT) as an in vitro diagnostic test (IVD) that is intended for clinical use and designed, manufactured and used within a single laboratory.  In 1976, the Medical Device Amendments (MDA) was enacted and amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a system for the regulation of medical devices intended for human use.  Although considered IVDs, the FDA chose to exercise enforcement discretion for LDTs with the justification that these tests were relatively simple, used only in the lab that developed the tests and were used for rare conditions. 

During his November 17th conformation hearing at the Senate Health, Education, Labor and Pensions Committee FDA commissioner nominee Robert Califf indicated that the FDA could have a new combination pathway ready for approval within a year.  He is trying to replace Margaret Hamburg, who left the FDA back in April.

During the hearing Califf agreed that the FDA’s existing structure for reviewing combination products is not suitable.  “It’s a strong view at the FDA that we need another pathway that will give the FDA the flexibility to require the data that’s needed to ensure the public the proposed treatment is safe and effective.

You’ve received “the call” from the FDA auditor.  After an understandable quick moment of panic, what should your next steps be?

At IMARC, we have participated in the audit preparation process for numerous sites who have been contacted for an FDA audit.  It is helpful for a site to know what the FDA auditor will use during their review.  In a past blog, we discussed a new document introducing a standardized Nonconformity Grading System, which was created by the former Global Harmonization Task Force (now re-named International Medical Device Regulators Forum) to assist regulatory authorities and auditing organizations. 

Recently, while on a monitoring visit for a physician sponsored IDE study in which IMARC was concurrently conducting a clinical audit, I was caught off guard by the question “do you know what the FDA Form 3674 is?”  I thought I had spent a good deal of my professional career working in the clinical research industry, I try my best to be a diligent student of the regulations and GCP guidelines, and even have tested my wits by passing the SOCRA certified clinical research professional exam.  However, I was stumped when it came to this mysterious form, albeit somewhat relieved that my co-monitor and the auditor that asked me were equally baffled by what it was.  At our auditor’s good suggestion, we took to finding the answer.  That night, she emailed FDAs FDAs [email protected] for their input.  This is really a fantastic tool in and of itself if you have not utilized it, someone from FDA will respond to your questions regarding good clinical practice in the field of clinical research.

In the wake of the recent Ebola pandemic, we realize the importance of pushing drugs and pharmaceuticals through the FDA approval process as quickly as possible. From drug discovery to FDA approval, the average drug takes roughly ten years costing $2.6 billion dollars during the process. Delaying the drug from reaching market just one day can cost the Sponsor millions and potentially the lives of patients hindered by the condition the drug is to treat. With the pressing need for cures and treatments, an expedited approval has the potential to be advantageous for all. Over a series of blogs, I will review the four FDA expedited review programs.

 When documenting your research observations, it is important to remember the adage, “If it wasn’t documented, it wasn’t done”.  As research professionals, we have an obligation to uphold the highest ethical standards and make all possible efforts to comply with Good Clinical Practice. We must take credit for what we do - and to take credit for what we do, we must properly document our work.

The FDA evaluates the disclosure of financial information from clinical investigators to determine the reliability of data submitted to the FDA and identify steps to minimize the potential for bias. The value of an investigator’s financial interest in the sponsor may have the potential to increase if the product is approved. 21 CFR 54 states that investigators must disclose significant equity interest in the sponsor, any proprietary interest in the sponsor and significant payments of other sorts from the sponsor during the time the investigator is carrying out the study and for a period of one year following completion of the study.

Recently, FDA issued a new draft guidance document through their online email notification system regarding proposed revisions to the ICH GCP Guidelines for Good Clinical Practice.  The draft guidance, titled “E6 (R2) Good Clinical Practice,” is currently in what FDA calls “Step 2 of the ICH Process,” which means that it was released for feedback by the ICH Steering Committee on 11 June 2015 to the regulatory authorities of the ICH regions (the European Union, Japan, the USA, Canada, and Switzerland).  This is very exciting news for the clinical research community, as the ICH GCP Guidelines have not been updated since they were originally released nearly 20 years ago in 1996. 

 A police siren blares, but only for a brief moment indicating that the police officer just wanted to make his presence known.

In turn, your surprise quickly morphs into frustration as you see the flash of red and blue lights in your rear view mirror.  You pull to the side of the road.

“Do you know why I pulled you over?” the officer posits staring at a roll of papers in his hand.

“Honestly, I am at a loss sir?” you sarcastically reply.  “I just got on the highway to test out my new car, which is just off the assembly line, I might add, and I wasn’t even up to the speed limit yet.”

As we are in an era of “patient-centered” medical care, the focus of health care now enables patients to make choices regarding their physicians, hospitals, and treatment options.  The transparency of medical costs allow patients to “shop-around” for their healthcare preferences, and gone are the days of simply letting health care providers guide medical decisions.  In a recent article on the FDA’s website, they have fostered this idea and announced their first ever Patient Engagement Advisory Committee (PEAC). This committee is part of the FDA’s Patient Preference Initiative, which was launched in 2013, and marks an additional way to incorporate patients’ views on benefits and risks with those of the FDA’s scientists, engineers, and medical professionals.