One "fun" thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process.
One of the key events in the saga was a controversial report issued by the Institute of Medicine that basically said we should eliminate the 510K process. Here are two articles about that:
You might find others.
What I would like to know for this discussion are several things, pick one or two to discuss:
1) Can someone come up with a brief bullet pointed history of this whole saga from the beginning? Hint: it started with an incident where a politician got the FDA to accept a 510K submission from a company when normally that 510K would have been denied.
2) What are some of the criticisms of the IOM's report and its integrity?
3) What do critics of the IOM report suggest instead? What do you suggest and why?
4) Has there been any recent information on this saga?
Spiral Medical Development
www.spiralmeddev.com
One of the critiques the IOM said about the 510 (K) process was that it lacked the legal basis to be reliable of the safety and effectiveness of moderate -risk class II devices. The reason why the 510(K) lack safety and effectiveness is because of its reliance on “substantial equivalence”. The IOM believes that relying on the substantial equivalence cannot guarantee that devices reaching the market are safe and effective. In fact, the majority of these substantially equivalent devices never go through review for safety or effectiveness. Thereby, the IOM are implying that the 510(K) does not determine if a device is safe or effective. I feel like this is a good point the IOM made about the substantial equivalent products. For instance, I can develop an LVAD that has “substantial equivalence” to the older LVADs, but who is there to check if the LVAD that I developed is indeed safe and effective. Thus, IOM does make a good argument to ensure 510(k) can determine a device as safe or effective.
Thus, the IOM proposes to develop a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide the assurance of this safety and effectiveness of Class II device that the 510(k) previously lacked. This new process would allow devices to the reach the market in aa rapid and least burdensome manner. I believe this suggestion is a good idea. The reason is that the FDA approval of medical devices is long as it is, especially for class III devices. Companies can get approval for the device aboard to avoid these regulations. Thus, causing an issue when the product is on market in the USA. Therefore, this new framework can allow the FDA approval process to be little fast and ensure companies are not getting approval aboard.
A brief history of this loophole begins with the creation of a regulatory agency for the benefit of the United States Populace.
-Medical devices came under FDA regulation in 1938 when the FD&C Act was passed, however this only allowed regulation after devices were placed on market.
-After the Drug Amendments in 1962 pre-market approval requirements were introduced for drugs, but not medical devices.
-Finally in 1976 Congress established Medical Device Amendments (MDA)
-MDA established the 510k process as a by product of the 3-tier classification system.
The regulatory framework behind MDA grew out of a Study Group by the Department of Health, Education, and Welfare and Dr. Theodore Cooper was the group's chairman.
-The main ideology behind the purpose of the MDA was to ensure safety and encourage innovation.
-Section 510k was created to address products that were on market prior to the enactment of MDA.
-Congress devised a scheme to phase the new MDA requirements into medical devices currently on market, this was done because of the past difficulties the FDA had in implementing the Drug Amendments to pre-1962 drugs.
-pre-1976 medical devices which were classified as Class I or II were not subject to pre-market approval as defined by MDA guidelines, however the key is that the Class III pre-1976 devices were also not subject to market approval which is contrary to the MDA guidelines and this action was taken because the FDA did not want to cause market disruption at the time.
-Now the loophole arises because all post-1976 Class III device are subject to full pre-market approval unless they are substantially equivalent to pre-1976 devices. This was done to prevent unfairness that results from allowing pre-1976 devices to remain on market while their counterparts would have to undergo stringent guidelines before entering the market.
-The practice of "piggybacking" was introduced in 1990 when Congress extended the limitations from pre-1976 devices to any legally marketed device, thus increasing the options.
-In 1995/1996 in Lohr vs Medtronic the U.S. Court of Appeals determined the standing alone, is not a finding of safety and effectiveness in regards to 510k and this was reaffirmed by the Supreme Court that substantial equivalence does not necessarily determine that it will protect the public.
References: https://dash.harvard.edu/bitstream/handle/1/11940233/ho_2012.pdf?sequence=1
http://www.pogo.org/our-work/reports/2009/ph-fda-20090218.html?referrer=https://www.google.com/
It seems that a recent lawsuit about power morcellators in 2014 has brought up this issue again. Dr. Amy Reed underwent surgery to remove uterine fibroids using laparoscopic power morcellation, an otherwise routine hysterectomy. In this process, a tool is inserted through a small incision in order to mince an internal structure so it can be extracted more easily. However, in undergoing this process, some hidden cancerous cells were also ground up in the process and had spread throughout her abdominal area.
Power morcellators utilized the 501k process in order to get clearance back in the 90s, but it seemed that this cancer risk had not been consideredduring the approval process. This spurred Dr. Reed and her husband, Dr. Hooman Noorchashm, to take action. Together the two rallied to get this procedure and the morecellator devices banned. Overall it seems they were somewhat successful as Johnson & Johnson had withdrawn three of their devices associated with this procedure, but it remains to be seen if the actual 501k procedure itself will see any changes.
References:
http://www.medscape.com/viewarticle/828688_3
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm393689.htm
In 2017, 82 percent of total devices cleared by CDRH were through the 510(k) pathway and so the importance of keeping the 510(k) updated is very clear. In recent years the FDA recognized the importance and has worked on establishing a voluntary, modern 510(k) pathway for demonstration of safety and effectiveness for certain moderate-risk devices. The agency's plan is to stimulate greater market competition to develop safer devices through this. A framework for this voluntary program was outlined in a draft guidance document released in April 2018. Following this in September 2019, a group of guidance documents was also released (the special 510(k) program, abbreviated 510(k) program, refuse to accept policy for 510(k)s, and format for traditional and abbreviated 510(k)s).
One "fun" thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process.
One of the key events in the saga was a controversial report issued by the Institute of Medicine that basically said we should eliminate the 510K process. Here are two articles about that:
You might find others.
What I would like to know for this discussion are several things, pick one or two to discuss:
1) Can someone come up with a brief bullet pointed history of this whole saga from the beginning? Hint: it started with an incident where a politician got the FDA to accept a 510K submission from a company when normally that 510K would have been denied.
2) What are some of the criticisms of the IOM's report and its integrity?
3) What do critics of the IOM report suggest instead? What do you suggest and why?
4) Has there been any recent information on this saga?
A 510(k) contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA must review the 510(k) and "clear" your device before you can legally sell or distribute it in the United States.
