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510(k) Approval Process & the Impact of Changes for Medical Devices

institute of medicine (iom)

There has been a lot of discussion in the news lately about the premarket clearance process for medical devices under section 510(k) of the Federal Food and Drug Cosmetic Act. This is the approval route by which the majority of medical devices get to market by showing they are comparable to an existing marketed or approved product.

Before coming to work at BioClinica, I worked for five years at a medical equipment manufacturer, Lunar Corp (now owned by GE), where I was actively involved in the 510(k) and PMA approval process.

The key issue manufacturers’ face is whether clinical data is needed to show safety and efficacy in order to obtain FDA approval to sell the medical device in the United States. Under the 510(k) approval mechanism, a manufacturer can obtain approval by showing the proposed equipment or software has “substantial equivalence to a predicate,” without the need for expensive clinical trials.  In simplistic terms, this standard has come to mean that a new medical device is safe and effective for its intended use if it is comparable to an existing marketed/approved product. This is a bit like a generic drug being approved without clinical trials simply by showing similar pharmacokinetics to the marketed product.

As I see it, the challenge with the 510(k) approval process is it has to cover everything from new surgical gloves, to imaging modalities to equipment and implants. Although they provide a class structure, the same basic process has to cover all these areas.

Recently manufacturers have come under scrutiny for using the 510(k) process for approval of high-risk medical devices such as pacemakers and for new technology where a predicate may not exist.  In April of this year, the FDA rejected the 510(k) submission from ProUroCare Medical for their prostate imaging system because it believed an appropriate predicate had not been identified.  According to ProUroCare, the “FDA specifically noted the lack of a comparable predicate device for use as an aid in visualizing and documenting abnormalities of the prostate detected by digital rectal examination.”

Concerns about the 510(k) approval process have arisen where manufacturers have selected a predicate that is no longer marketed (due to poor performance) yet the device serves as a valid predicate because at some point it was legally marketed either as a result of a 510(k) approval or it was on the market prior to May 28, 1976 when the 510(k) regulations came into effect.  The net result is that some of the predicates being used are surprisingly tenuous, particularly given the pace of innovation and science.

In addition there have been questions raised as to whether some devices approved under the 510(k) process are safe.  Several former FDA employees have claimed that they were pressured into changing their opinion on the safety of CT devices for colon cancer screening despite concerns over radiation dosage.

Manufacturers have responded by claiming the FDA is seeking to disrupt and delay the clearance of new medical devices, in what is an established and effective process, and that significant changes will stifle innovation.

The working group of the Centers for Devices and Radiological Health (CDRH) of the FDA issued their recommendations on August 4 on what should happen to the 510(k) process. See the FDA press release here. It is beyond the scope of this post to discuss this report in detail, but a copy can be downloaded here. According to industry analysts, “no radical change to the current process appears likely.” (See the full story here). Included in the proposal is the creation of a new device class, called “class IIb” devices, which require manufacturers to provide some form of clinical evidence to prove effectiveness.  Apart from infusion pumps, it remains to be seen what products fall into this category.

From a medical imaging perspective it looks as though the recommendations from the FDA working group will have minimal impact. However, the report that could have a major impact on the 510(k) approval process is that from the Institute of Medicine that is expected next year.


The IOM will issue a report in mid-2011 that will answer two the key questions:

  1. Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
  2. If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

There are significant radiation dosage safety concerns from medical imaging devices, a topic that I have written about in previous imaging blog posts.

It will be interesting to see what happens with the IOM, and whether they think the 510(k) approval process provides adequate safeguards. In my opinion, more could be done to protect the public and patients, without creating an excessive burden on manufacturers. The concept of using predicate medical devices to show substantial equivalence is a good one, but the public expects FDA approval to signify that a device is both safe and effective.  To achieve this, the predicates used must be scientifically valid.

What is your view on the recent FDA 510(k) approval process?




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