The question was raised whether the current 510(k) process is ensuring that the medical devices released to the market are safe and effective. The Institute of Medicine (IOM) investigated this question and found that the current 510(k) process is flawed based on its legislative foundation. One of their findings was that when the FDA assesses the substantial equivalence of a device, it does not necessarily require evidence of safety or effectiveness, but rather the product's safety and effectiveness is assumed based on its similarity to the predicate design. The IOM also found deficiencies in the FDA's post market surveillance of products. They recommended that the FDA should rather develop an integrated premarket and postmarket regulatory framework that provides assurance of safety and effectiveness throughout the device life cycle.

Any change to the 510(k) process would have implications to medical device development, and initiating a new 510(k) framework would be very significant. The IOM is suggesting that the new framework be based on sound science, so while many companies today are relying on their predicates to prove safety and effectiveness, this new framework would require much more solid evidence, meaning that companies would have to change their strategy and do a lot more work to prove that their new device would be safe and effective. I would imagine this would significantly increase development time and cost for the average medical device manufacturer today.

References:
http://nationalacademies.org/hmd/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx
http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a reasonable assurance of safety and effectiveness before a device can be marketed; It is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process. Recently some policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market. FDA asked IOM to answer 2 questions: 1) Does the current 510(k) clearance process optimally protect patients and promote innovation in support of public health? 2) If not, what legislative, regulatory, or administrative changes are recommended to achieve optimally the goals of the 510(k) clearance process?
After all the reviews, IOM came up with 2 conclusions: 1) The 510(k) clearance process generally is not intended to evaluate the safety and effectiveness of medical devices because the standard for clearance is substantial equivalence to any previously cleared device 2) Information that would allow an understanding
of the extent to which the 510(k) clearance process either facilitates or inhibits innovation does not exist.
The Institute of Medicine concludes that the FDA should replace the 510k with a standard that provides reasonable assurance of safety and effectiveness.

Throughout the years lawmakers and government departments such as the FDA have modified and added regulations to ensure that it tackles on all possible issues and meets their mission statement while maintaining a watchful eye on any possible failures in the system. The FDA currently is working on setting up regulations for new medical devices for example that is involved more heavily with technology such as products that transmit patient information over-the-air via internet access or bluetooth, or other devices that are becoming innovative and requires heavy testing for classification. Using the current system with these new devices and having 510 (k) and PMA to regulate it becomes difficult, this is more or less why these two documents have become greatly extensive and covering many grey areas as possible. As the previous participant on this forum mentioned, the Institute of Medicine has made conclusions on the 510 (k) clearance process and how these systems are clearing new products. The problem here lies that most products are being too similar to one another and it is becoming harder to evaluate the safety of these products because they can lie within the acceptable range but may exhibit flaws and potentially harm the general public. A new standard might need to be initiated to reflect with today's current age of medical device development and the future as well.

The FDA is continuously improving its 510k process to keep themselves aligned with the evolving technology and new devices. However, the Institute of Medicine report points out that the existing process was never meant to screen out the inefficacy in products. The biggest issue at hand is that the existing process only requires the companies to show previous similar products that are safe. This way the companies are just sort of parlaying on without the examination of safety on those products. The process is not completely ineffective but rather needs to be amended with changing times. However, this is is a tedious process as this will only increase lobbying for proposals or amendments in the congress. Meanwhile, the FDA could tighten its grip on tracking the class 2 devices that are already on the market to mitigate it. The FDA needs to invest in resources for designing or enhancing the integrated premarket and postmarket regulations whether it is to create a new committee that will deal with the amendments or coming up with more documentation that covers up the flaws and requires more information and accountability from the companies with the existing 510k documents.

I found another article that specifies the issues with the FDA’s center of medical device and radiological health. The main reason this article was released after the writer’s wife used the Karl Storz power morcellator which spread cancer throughout her abdomen. He focuses his article on life sustaining medical device flaws. He believes that the FDA focuses more on boosting the economy with innovations that do not take into account the safety of the public. The 510k is considered to a “dominant legal tool” which is used by CDRH. Noorchashm focuses on the fact that the 510k should be updated to consider the safety of Americans and users more than the innovation or capital the device could bring to the economy.

References:
https://www.mddionline.com/510k-under-attack
http://www.philly.com/philly/blogs/healthcare/A-Modern-Day-Wolf-in-Sheeps-Clothing-FDAs-Center-for-Devices-and-Radiological-Health-CDRH.html#qmBChtyv9S4YS5wb.99

Here another example:
No More 510(k)-only PMA required for all Automated External Defibrillators (AEDs)
FDA has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most.
The reason for the change, FDA explained in a press statement, was that regulators have become aware of "approximately 72,000 medical device reports associated with the failure of these devices."
"Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs," FDA noted. "The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.
FDA said it will not take action against any AED or AED accessory already on the market until 29 January 2020, when it expects all marketed AEDs to be covered by an approved PMA. New devices, however, will be required to be covered under the PMA process much sooner.

Reference: http://www.raps.org/Regulatory-Focus/News/2015/02/02/21225/High-Failure-Rate-for-AEDs-Prompts-FDA-Change-in-Regulatory-Policy/
Here also another example:
https://www.markey.senate.gov/imo/media/doc/2013-01-10_FDA_RE_Sound.pdf

There has been some updates to the 510(k) information in response to the IOM report to clarify that FDA includes in its 510(k) review the safety and effectiveness of the medical device, although no significant changes were made to the 510(k) process itself.

FDA has issued a memorandum (link below) in January clarifying that its review of the medical device in the 510(k) program involves a substantial review of safety and effectiveness (pg 44).
https://www.regulations.gov/document?D=FDA-2016-N-1149-0040

The current information on FDA website about premarket notification states "A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA."
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

In addition, FDA has issued a guidance document in August 2016 "Deciding when to submit a 510(k) for a change to an existing device" which emphasizes any change or modification that could significantly affect safety and effectiveness of the device requires new 510(k) submission.
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm514771.pdf

The article I looked at stated that the IOM report on the 510(k) process contains broad recommendations that may have significant consequences and impacts on the medical device industry. Specifically, IOM concluded that the 510(k) process “cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device” and that “the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”
Moreover, the report asserts that, FDA's finite resources would be better invested in developing a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use, the committee said. The report also maintains that FDA should ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible.
What this report does is require that all class II devices that are substantially equivalent will now have to go through extensive studies and additional approval process. It is not clear that there is evidence to make these recommendations. Throwing out the 510K process in favor of a more rigorous review process in the absence of evidence that there is an unacceptable risk posed by current class II devices has the potential to cause considerably more harm than good. It was clear given this restraint that additional regulations especially in the pre-market arena will result in vastly fewer devices coming to market. This result will help neither inventors nor patients.

http://www.policymed.com/2011/07/institute-of-medicine-report-medical-devices-and-the-publics-health-the-fda-510k-clearance-process-a.html
In another article I read that “FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programmes,”
Some of the Institute of Medicine’s recommendations, such as the recommendation to design a new regulatory framework for Class II (moderate risk) devices, may require congressional actions. However, the FDA plans to continue its review of the report and to solicit input from stakeholders regarding the recommendations in the report involving existing FDA authorities.
https://cardiacrhythmnews.com/fda-to-seek-public-opinion-on-institute-of-medicines-510k-recommendations/

The report by the institute of medicine talks about how the 510k process has become burdensome and time-consuming and addressed the inadequacies of post market regulations of medical devices by the FDA. The report mainly focuses on under regulation of medical devices even though sporadic cases of adverse effects of the device have been reported. It also argues about how the 510k process uses age old policies and instead of modifying this lengthy process, it is necessary to create a new regulatory framework with reasonable objectives that does not compromise the safety or effectiveness of the devices throughout the lifecycle of the device or hamper the innovation or timely approval of new devices that show promising results.

http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf

It seems like from an article I read the 510 K process is towards the CDRH center. CDRH employees have expressed concerns to the current 510 (K) program because some of the devices being evaluated are rather complex. The reviewers ability to make a well-informed decision was undermined by the poor quality of the 510 K submissions. There are three changes that the CDRH committee at the time wanted to be done:
1) A streamline pathway for lower-risk denovo devices
2) A new subclass (Class IIb) for moderate-risk devices
3) The creation of an internal CDRH Science Council
With these proposed changes to CDRH they also had changes towards the 510 K process it wanted as well.
• Streamlining the review process for innovative, lower-risk products, called the “de novo” process;
• Publishing guidance for industry to clarify when clinical data should be submitted to increase predictability and transparency;
• Developing a network of external experts who can use their knowledge and experience to help the agency address important scientific issues regarding new medical device technologies;
• Establishing a new Center Science Council of senior FDA experts within the agency’s medical device center to assure more timely and consistent science based decision making; and
• Improving training for CDRH staff and industry

The article posted with this week's lecture: "Medical Devices and the Public's Health" by the Institute of Medicine (IOC), gives an overview of the IOC's perspective on the 510(k) process over the past 35 years. The IOC points out that for a medical device of a moderate risk to enter market, it must prove substantial equivalence to a predicate device that was on the market before the Medical Device Amendments of 1976. This leads the FDA to believe that any medical device that proves substantial equivalence is safe and effective enough to not require any inspection or investigating since they are believed to follow the same design as these predicate devices with market success. This draws concern from the IOC since devices that were on the market before 1976 were never "systematically assessed for safety and effectiveness - but they are being used as predicate devices". The main reason the IOC believes that this regulation flaw has been overlooked is because the consistent use of these predicate devices in clinical settings have shown enough success to the point that any further examination of their safety/efficacy will be viewed by the FDA as redundant. The IOC concludes by bringing the concept of pre- and postmarket regulatory surveillance to attention.

One surveillance technique mentioned in another IOC article (1) is to allow the FDA to regulate the labeling of a drug product after its market release (to immediately relabel any adverse effects found postmarket). Other techniques mention the distribution of medical devices only to facilities that have been specifically trained to specialize in that medical device itself rather than to any physician, reducing the likelihood of the device being misused (while also reducing the revenue generated by the device). A final important regulatory technique requires medical device companies to have an "active adverse event surveillance system", such as an online link easily accessible by patients and specialists to direct their complications and concerns. All of these techniques require a monetary investment by the medical device companies, which some companies deliberately do not do because, according to Dr. Simon's Orthopedics course, the cost of losing a lawsuit is less than implementing such regulatory measures.

(1) https://www.ncbi.nlm.nih.gov/books/NBK52937/

The 510(K) process is a process used to clear all medical device and claims, that they are safe and effective to go into the market. The institute of medicine (IOM) issued a report in 2011 on the 510(K) process regarding approval and releasing of safe and effective medical device.

The IOM challenged that claim which was commissioned by the FDA, that the 510(K) process is neither making safe and effective device available to patients nor promoting innovation in the medical device industry. They also addressed key attributes of an improved process, including that it be clear, fair and predictable and make use of regulatory tools and authority to ensure safety and effectiveness throughout the duration of a product's use.

Recommendations where provided by the IOM that FDA should analyze what barriers hamper the efficient and effective use of its regulatory tools and identify ways to overcome them. According to the FDA, the agency has already taken several steps to improve the process that includes issuing a draft guidance clarifying when manufacturer changes to a 510(K) cleared device already on the market warrants a new 510(K) submission. 

With the changes that the FDA made and the continuous commitment to an aggressive action plan designed to improve predictability, consistency, and transparency under the existing statutory framework for not only to the 510(K) process but also its device review programs in general, this will help to enforce proper scrutiny of medical device to prove safety and efficiency and making this device available in a timely manner to the patient and public in need.

Reference: Institute of medicine. 2011. medical device and the public's health: the FDA 510(K) Clearance process at 35 years