510(k) Approval Process For (Cosmetic) Medical Devices

FDA Adverse Event Information, Medical Device Approval Process, and FDA Corruption

510(k) Approval Process For (Cosmetic) Medical Devices

PostPosted by DCNGA » Thu Aug 18, 2011 2:57 pm

http://www.dcwderm.com/arch.pdf

Most devices in the United States (approximately 98%) are class II devices and are approved via the 510(k) application,
in which the safety and effectiveness of a device are compared with those of a “substantially equivalent” commercially available device. The FDA action on a 510(k) application is faster than on a PMA (90 days vs 180 days), less costly to the manufacturer (average cost, $3000 vs $300 000), and requires less premarket testing.

The 510(k) process does not require clinical data; in fact, only 10% of 510(k) applications have any clinical data at all. It is the “least burdensome” method for getting a device to market defined in the FDA Modernization Act of 1997.12 This Act also provides for early collaboration with the FDA in device protocols for development to make the development and approval process more efficient and less expensive.

Most lasers, radiofrequency devices, intense pulsed light systems, and surgical facial implants have been approved by this pathway.

There are some obvious paradoxes in the regulatory framework for devices, particularly with the 510(k) pathway. A device may be approved by this method when the manufacturer shows that its function, safety, and effectiveness are substantially equivalent to those of a device already on the market and that may have been on the market since prior to 1976 (and thus approved under the older, less stringent regulatory framework). Subsequently, the device may be touted as an innovative, advanced product. So we must ask, which is more accurate, the claim of similarity to a pre-1976 device proposed to the FDA, or the claim of uniqueness advertised to the consumer? In any case, the physician should be aware that the specific device may have never been tested with clinical trials to assess its safety and effectiveness but may have relied on laboratory or animal studies.


v DON’T jump on the bandwagon as a result of marketing pressure. Some adverse effects may take time to manifest. This is particularly important in new technologies. Consider, for example, Thermage (Thermage Inc, Hayward, Calif ) radiofrequency device treatments that were touted on the Oprah Winfrey show.15 Myriad patients rushed to undergo the procedure described there.

As of September 2005, there have been 155 adverse events reported on the Manufacturer and User Facility Device Experience (MAUDE) database.16 A substantial proportion of these events were the development of fat atrophy and scarring 3 or more months after the procedure. Subsequently, the manufacturer recognized the problem and changed the treatment algorithm. Hopefully, the new treatment parameters will avoid or mitigate these sequelae.
"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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Re: 510(k) Approval Process For (Cosmetic) Medical Devices

PostPosted by DCNGA » Fri Aug 19, 2011 9:45 am

More about 510(k) process and 'predicate' devices (upon which all current laser/light devices received their FDA clearance):

Written in 2002: Aron Youngerwood (April 2002) Harvard Law School

http://leda.law.harvard.edu/leda/data/4 ... rwood.html

Since the PMA process is time-consuming and expensive, most manufacturers generally attempt to avoid it by claiming their device is “substantial equivalent” to a “predicate” (pre-1976) device. If this is the case, the new device will be placed in the predicate’s class and can be marketed immediately subject to any regulations applicable to the predicate device. As one commentator has noted: “510(k) submission has become the option of choice for bringing a new device to market”[51]. However, devices without predicates and not judged to be substantially equivalent to a pre-1976 device, are placed automatically in Class III and are subject to the PMA process.

The term “substantial equivalence”, although originally undefined and left to the interpretation of the FDA[52], was eventually defined in the SDMA of 1990. A device is “substantially equivalent” if, in comparison to a predicate device it (1) has the same intended use and technological characteristics[53] as the predicate device; or (2) has different technological characteristics that do not raise new questions of safety and effectiveness, and the manufacturer demonstrates that the device is as safe and effective as the legally marketed device[54].

Once the device is determined to be substantial equivalent, it can then be marketed in the U.S and is generally subject to the same regulatory requirements as its predicate[55]. However, if FDA determines that a device is not substantial equivalent, the device is placed in Class III and must go through the PMA process (alternatively, the applicant may resubmit another 510(k) with additional data, petition for reconsideration or reclassification, or seek judicial review[56]).

Significantly, prior to the 1990 amendments, the FDA did not generally require human clinical trials in determining substantial equivalence [57]. However, following the 1990 amendments, the FDA were given express authority to require the submission of performance data, including data from clinical trials, in order to make a substantial equivalence determination[58].

Furthermore, in addition to this lack of a mandatory requirement for clinical human testing, the introduction of “piggybacking”, a process that allowed post-1976 devices judged substantially equivalent to pre-1976 devices to serve as predicates themselves [59], made it even easier for manufacturers to market their products and avoid the FDA PMA process. The significance of this applies particularly to cosmetic lasers (as will be discussed later) given that laser manufacturers are able to avoid the more demanding premarket approval process by making incremental changes to the lasers and relying on the substantial equivalence procedure to obtain marketing approval.

It should further be noted that the legislative history of substantial equivalence reveals that the introduction of the concept was not to insure safety and effectiveness, but rather was a concession to industry to treat pre- and post-amendment devices equally [60]. Indeed, the effect of the introduction of the substantial equivalence requirement was to enable manufacturers to evade the more stringent PMA requirements giving them a fast-track for getting their products on the market[61]. A 1988 General Accounting Office report stated that of the 36,000 medical devices marketed after FDA review, only 6% went through the PMA process while the other 94% went through the substantial equivalence procedure[62]. Furthermore, the FDA rarely found that a new device was not substantially equivalent to a predicate device selected by the applicant. The rejection rate was approximately 2% [63].

Criticism arose as to use of the substantial equivalent test for deciding whether a device should be marketed, especially given the fact that the test did not focus on the most relevant question, namely is the device safe and effective? Instead, the test focuses on a secondary question, namely, is the device substantially equivalent to a pre-enactment device with regards to safety and effectiveness[64]? Furthermore, there was general criticism of CDRH’s unofficial policy to reject only 2% of 510(k) applications which “encouraged approvals in all but the most obviously deficient 510(k) applications.”[65]

The FDAMA addressed the issue of delays in premarket notification review time[66], and the need to speed up the introduction of new technologies. An important FDAMA provision required the FDA to consider only the “least burdensome means” of evaluating effectiveness that would have a reasonable likelihood of resulting in approval[67]. The FDAMA amended the definition of substantial equivalence by enabling the CDRH to request clinical data as part of the substantial equivalence determination, but limiting the type of data requested to the “least burdensome” data needed to determine substantial equivalence – therefore information not directly relevant to substantial equivalence, e.g. information regarding absolute safety and effectiveness of a device, may not be requested[68]. Thus, the Senate report, prior to the implementation of the FDAMA, stated that the FDA “must ask for the least burdensome type of valid scientific evidence that will meet Congress’ criteria for effectiveness.”[69]

This drive for efficiency so as to ease the process by accelerating device approval, as well as to reduce the cost for private companies to get their products on the market was, in this writer’s opinion, to the detriment of the public welfare in terms of proper assessment of device safety and effectiveness, even though supporters of the FDAMA stated that this improved patient access to important new technologies.

"It is a good thing to learn caution from the misfortunes of others."

"If you wish to succeed in life, make perseverance your bosom friend, experience your wise counselor, caution your elder brother, and hope your guardian genius."
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