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CDRH Preliminary Internal Evaluations -- Basic Questions and Answers on Preliminary Reports

What are these reports?

The FDA’s Center for Devices and Radiological Health (CDRH) released two major reports recommending actions the Center could take to improve the way it oversees medical devices, by fostering innovation, enhancing regulatory predictability, and increasing patient safety.

The first report provides preliminary recommendations to strengthen a premarket review process called the 510(k) program, a common way for medical devices to go to market. The recommendations call for better information from the start of the review process to assure patient safety while providing the clarity and predictability industry needs to prepare premarket submissions.

Along with the 510(k) report, FDA is also releasing a report by a separate CDRH task force that was charged with evaluating how the center incorporates new scientific information into its regulatory decision making. CDRH is seeking to ensure regulatory predictability and yet adapt to emerging science.

Who prepared the reports?

The two reports were prepared by two separate internal groups within the FDA’s Center for Devices and Radiological Health (CDRH). Both were convened in September 2009. The 510(k) Working Group was tasked with evaluating the 510(k) program and identifying potential improvements, especially actions that could be taken in the short term under FDA’s existing statutory authority. The Task Force on the Utilization of Science in Regulatory Decision Making was asked to identify steps CDRH should take to ensure regulatory predictability and yet adapt to emerging science. This meant helping CDRH become more predictably adaptive, setting clearer guidelines about when new scientific information might prompt a change in how CDRH treats a given product, including how that product might be reviewed before it goes to market.

The reports draw heavily on input conveyed by the public during two open meetings earlier this year and in other comments entered into dockets opened by each group.

What happens next?

The recommendations contained in these report are preliminary. FDA has not made any decisions on specific changes to pursue. FDA is soliciting public input on the recommendations discussed in these reports, including the feasibility of implementation and potential alternatives. Once its assessment of public input and other necessary reviews are completed, FDA will announce which improvements it will implement as well as projected timelines for implementation.

In addition, the Institute of Medicine is conducting an independent study of the 510(k) program, at the request of FDA. A final IOM report is expected in the summer of 2011. There may be changes proposed in today’s reports that the Center will refer to the Institute of Medicine for further review.

What is a 510(k)?

The FDA classifies medical devices into three categories based on risk. Class III devices such as heart valves, represent the highest level of risk and generally require premarket approval to support their safety and effectiveness. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications - also called 510(k)s - that demonstrate they are substantially equivalent to a predicate, or a device already on the market. FDA refers to devices that demonstrate substantial equivalence as having been cleared for marketing by FDA rather than approved for marketing by the agency.

Why are changes needed in the 510(k) program?

In recent years, concerns have been raised about whether the current 510(k) program achieves its goals of making safe and effective devices available to the public while also fostering innovation. Concerns have centered on whether devices enter the market without sufficient safety and effectiveness evidence and a perceived lack of predictability, consistency, and transparency viewed as hindering device development.

What is a de novo device?

De novo devices are lower risk devices that cannot be cleared through the 510(k) process because they lack a predicate device and yet do not warrant the more rigorous premarket approval review applied to higher-risk devices. These products are reviewed through what is known as the de novo classification process.

Examples include:

  • K081754 OVAl™ Test - Ovarian adnexal mass assessment score test system.
  • K081406 SNaP Wound Care Device - A non-powered suction apparatus device intended for negative pressure wound therapy, which is the application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps and grafts.