US FDA : The 510(k) - Part II (Page 2 of 2)

This approach required a fundamental change in FDA culture.  FDA reviewers had to recognize that there were alternative ways to meet regulatory requirements.  They would have to consider the spirit of the law rather than just a literal interpretation. The FDA had to open communications channels with the industry, offer assistance and negotiate solutions- all in the interest of public health and promoting a reasonable use of time, effort and costs.  Reviewers were thus discouraged from asking for data and information that did not directly affect the safety and effectiveness of the device.  They were asked to use appropriate risk/benefit criteria in decision making, to consider historical data, to accept “state of the art” scientific principles and methods and to use consistently guidance documents and standards.

The FDA began to consider how to conserve both industry and FDA resources while continuing to protect public health.  The FDA developed additional guidance documents and use of special controls to limit regulatory burdens and also improved access to information on its web site.

A tiering system for medical devices was then developed.  It was based on the level of complexity and level of risk of the devices.  The FDA then exempted most of the Class I devices from the need for 510(k) clearance.  FDAMA also gave the FDA authority to exempt Class II devices and the FDA published a list of these, too. Finally, the FDA began a review of those Class III devices, which were in distribution before passage of the Medical Device amendments of 1976.  Some of these will be down classified to Class I and either exempted or “reserved”.  “Reserved” devices are those that are intended for a use that is of substantial importance in preventing impairment to human health or that present unreasonable risk of illness or injury.  Some of these Class III devices are being down classified to Class II and they either will be considered “reserved” requiring a 510(k) submission or will be subject to “special controls”.  These “special controls” include, for example, a requirement to meet a consensus standard, follow a specific guidance document or be subject to post-market surveillance.

The New 510(k) Paradigm

The next important step undertaken by the FDA, under FDAMA, was to present medical device manufacturers with two optional approaches in addition to the “traditional” 510(k).  The FDA called this streamlining of the 510(k) process: “The New 510(k) Paradigm”.  The first new option is called “The Special 510(k)”.  It allows you to submit a 510(k) without the detailed data normally included in a “traditional” 510(k) that demonstrates substantial equivalence of the modification.  Instead, you must submit summary information that results from your design control process.  Your design control process must conform to the U.S. Quality Systems Regulation.  We will discuss in detail requirements for the “Special” 510(k) in a future column.

The second new option is the submission of an “abbreviated” 510(k).  This submission is appropriate when a guidance document exists, a special control has been established, or the FDA has recognized a relevant consensus standard. It permits submission of a summary report and, if you rely on a consensus standard, a signed declaration of conformity.  This option will also be discussed in more detail in a future column.

Our first priority is to discuss in detail the “traditional 510(k).  We will do this next time.

Until then, stay safe and healthy!

Norman F. Estrin, Ph.D., RAC

May 5, 2003

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NOTE TO READERS: Please understand that in order to make FDA requirements more understandable, I do simplify some of the language and omit some details. You must rely on the actual regulations-not any of my columns to ensure you meet FDA requirements.