The FDA released its four main priorities for 2012, and the focus of the FDA will
The medical device industry seems to be a limitless pathway of innovation, creativity, and advancements. However, navigating this pathway can be a challenge, and as increasingly complex and combination products enter the arena, more guidance is required to steer the way.
MassDevice reports that the FDA missed its second deadline to submit a proposal to Congress for the Medical Device User Fee & Modernization Act (MDUFMA), which is set to be renewed this year. The device industry and the federal watchdog agency have been in discussion over the fees mandated by the Medical Device User Fee & Modernization Act.
CBS recently revisited an important consumer health topic – the misrepresentation of stem cell treatments on the internet. In the 60 Minutes investigation, Dr. Joanne Kurtzberg of Duke University comments that there are ‘huge dangers’ of injecting unregulated stem cell treatments into a patient’s blood or spinal fluid because “little fragments and debris would get trapped somewhere in the blood stream and could cause a stroke, or in the brain [they] could cause an inflammatory reaction.” You can read the transcript here, and find the videos from the previous installments of the story from 2010 here and here.
The Code of Federal Regulations define vulnerable research subjects, and how those vulnerable subjects should be protected. 21 CFR 50.53 describes the circumstances under which children may participate in an investigation involving greater than minimal risk and no prospect of direct benefit . In order for these subjects to participate in clinical research trials, it is the researcher’s duty to ensure that these special protections are respected. It is unimaginable that these federally mandated laws and regulations could be discounted and ignored.
An article in Healing Innovations caught our eye. It reports that the FDA recently released a standard operating procedure (SOP) called “SOP: Management of Review Staff Changes During the Review of a Premarket Submission.”
Today there is no national standard for the competence or credentials of healthcare vendors. There is no specific requirement for licensure, certification, registration, or education of healthcare vendors. However, the Joint Commission recognizes a few standards that affect anyone who may directly impact the quality and safety of patient care. Clinical monitors are not directly involved in patient care, but we can have impact on the safety and quality of the care of patients being treated in clinical research trials. In fact, GCP is our standard for ensuring data is accurate and credible and that trial subjects are protected from harm. Because of this influence, some healthcare institutions are considering monitors as healthcare vendors. Thus we are faced with the same dilemma the pharmaceutical and medical device representatives are dealing with at this time – vendor credentialing.
Recently the FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.
It is not unusual for a monitor to come across upwards of a dozen Notes-to-file at a monitoring visit. At some sites it can seem as though the art of the Note-to-file is perfected as a Magic Eraser with regard to explaining away regulatory discrepancies. The regulatory purist in me shudders at this practice; but at my last monitoring visit, I stepped out of my normal comfort zone and recommended that my site staff colleagues compose several Notes-to-file to document resolution efforts that would otherwise be doomed to follow-up item purgatory. A Note-to-file should not be the immediate solution to a nagging regulatory issue, but there are several instances that can elevate this documentation tactic to preferred status.
Following an FDA inspection and exit interview, the FDA investigator will discuss the findings from an inspection and if deficiencies are found, a FDA 483 Inspectional Observations may be issued. The 483 describes any inspection findings that represent deviations from applicable agreements and regulations. The response to a FDA 483 is crucial. An article published in GxP Perspectives highlights sentence fragments from Warning Letters which seem to indicate a missed opportunity to avoid a Warning Letter following an FDA 483:
On November 10th, a FDA press release announced they issued a draft guidance aimed at fostering early-stage devices within the U.S. The guidance contains new approaches toward early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protection. The FDA is seeking a small number of companies that could pilot the new approach, as the results of the pilot will help inform the final guidance.
Back in October, Reuters reported that the FDA is seeking public input on a plan to create a network of outside experts to help understand the new technology in medical devices. The goal of panel would be to help speed up device approvals.
This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.