510(k) Myths vs. Facts

Posted on May 12, 2012. Filed under: Syringe Blog | Tags: , , , , , |

Myth #1:  Substantial equivalence involves showing that a new device is similar to an old and outdated product on the market before May 28, 1976.

Fact: This is perhaps the most common misunderstanding of the 510(k) program that results in unwarranted criticism. In reality, it is extremely unusual by today’s standards for a new device to go to market with a comparison to a 30-year-old device. The majority of today’s 510(k) clearances result from comparisons to today’s state-of-the-art technology. While it is true that Section 510(k) initially envisioned that products compared to a medical device on the market prior to enactment of the 1976 Medical Device Amendments could be marketed after being determined to be “substantially equivalent” SMDA amended the law to refer to comparisons to “legally marketed devices.” SMDA also established that a new device can not be found substantially equivalent to a device that has been deemed misbranded or adulterated and removed from the market. Additionally, FDAMA authorized FDA reliance on national and international consensus standards which usually reflect state-of-the-art test methods developed to assess the latest  in device technology. This evolution in the program, coupled with FDA’s authority to require virtually any data necessary for decision-making, has made the 510(k) program one of the most progressive premarket review programs in FDA. Perpetuating this notion that new devices are simply compared to older devices as a means to market does a considerable disservice to the 510(k) program and undermines the program’s true value and contribution to the protection of the public health.

Myth #2:  The 510(k) program is a “quick and easy” way for manufacturers to get their product into the market.

Fact: The 510(k) program has been designed to provide a flexible means to appropriately regulate a wide variety of medical devices, and places appropriate regulatory requirements where necessary. Contrary to what some detractors espouse, today’s 510(k) program is anything but a “quick and easy” way to market. While 510(k)s for the simplest of devices (e.g., syringes) may experience a streamlined evaluation, consuming less than 90 days of FDA review, any greater degree of regulatory burden would represent a waste of FDA resources with little to no public health benefit. Likewise, modifications to legally marketed devices may be eligible for a review of less than 90 days, but again, the rigor of FDA’s evaluation matches the potential impact of the modification on the safety and effectiveness of the device and relies heavily on the design control provisions of the Quality System Regulation (QSR). For devices that represent significant changes in intended use or involve changes in technology, it is not uncommon for review times to exceed 90 days and require several rounds of FDA review. From a perspective of difficulty and scientific rigor, simple devices may go to market based on a comparison of specifications, but as a device’s public health significance, technological complexity or risk increases, so does the scientific demands imposed by FDA’s reviews. Today, it is common for 510(k) submissions to be based on batteries of non-clinical tests, including testing against national and international consensus standards. Further, it is not uncommon for FDA to require clinical evidence to support certain decisions where this level of scientific rigor is warranted. The necessity for clinical evidence is not solely dependent on the class of the device but is instead derived from the risk analysis that is conducted as part of the design validation aspect of design controls. Manufacturers of class II and class III devices are responsible for complying with design control requirements under the Quality System Regulation. They are therefore responsible for conducting a risk analysis and determining the amount of supporting data, preclinical and clinical, necessary for the premarket submission and maintaining it in the design history file for FDA inspection. The bottom line is that there are instances where the demands of today’s 510(k) review process becomes a barrier to market entry that some companies do not have the ability or financial resources to overcome.

Myth #3:  Device malfunctions and patient injuries result from devices undergoing 510(k) review and serve as evidence that all devices should undergo the rigors of premarket approval to ensure their safety and effectiveness.

Fact: There are many reasons why critics of the 510(k) program argue that all devices should receive premarket approval. Device malfunctions that result in patient injury and device failures discovered in the postmarket period are frequently cited in support of the argument that all medical devices should follow the PMA process. One oft-cited example of a presumed “failure” of the 510(k) process is the Vitek TMJ implant. Five years after clearance of the device, FDA became aware of complaints of injuries attributed to the deterioration of the device material. Subsequently, FDA issued a letter citing good manufacturing practices (“GMP”) and medical device reporting (“MDR”) violations. Based on this unfortunate experience, it has been inferred that had the device been regulated through the more rigorous PMA program, the failures would not have occurred. This line of thinking is simply flawed. Manufacturing problems can only be addressed through robust quality systems, not paper reviews that are conducted at FDA headquarters. Likewise, clinical evaluation in the premarket period cannot identify or predict all problems that may occur when a device is made commercially available and placed in widespread distribution.  Further, the long-term effects of devices will never be fully identified and problems eliminated by clinical evaluation in the premarket period, whether the FDA review is through the PMA or 510(k) processes. In essence, the experience cited by the program’s critics is independent of the pathway to market.
Most importantly, the 510(k) program is only one of many regulatory controls FDA has in place to ensure the safety and effectiveness of medical devices, regardless of their path to market. In addition to obtaining FDA authorization to market a new device, manufacturers must comply with the other general controls including good manufacturing practices through the Quality Systems Regulation and medical device reporting, as well as any special controls. Special controls may include performance standards, guidance documents, post-market surveillance, device tracking, and other activities needed to provide a reasonable assurance of safety and effectiveness.

Myth #4:  The Third Party Review Program that is available for select devices subject to 510(k) is an “easier” path to market that avoids FDA review.

Fact: Following enactment of FDAMA, FDA has accredited a number of independent third party review organizations to perform the premarket review of select class I and class II devices subject to 510(k) requirements. Like the 510(k) process, the “Accredited Persons Program” is misunderstood and misrepresented and has been a source of unfair criticism. While it is true that this program may speed up the review process, any increase in efficiency is largely attributable to the fact that the review commences immediately upon assignment and usually does not languish in a queue. The premarket review is not conducted by less qualified review scientists. Also, contrary to statements related to the program, including some made to Congress, FDA remains responsible for the final decision and the overall process is no less stringent than one conducted internally by FDA’s review scientists.

View AdvaMed 510 (k) Myths vs. Facts ~ PDF










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