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FDA Guidance on 510(k) Submissions

Medical Device & Diagnostic Industry Magazine
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An MD&DI June 1997 Column


To the Editor:

In the Help Desk column entitled "Submitting a 510(k) for Changes in Device Design" (March 1997), FDA helps the editors to determine whether changes to a preamendment device warrant the submission of a 510(k) premarket notification. The device in question can be inserted into the body for aspirating body fluids. The changes to the device included: the addition of an O-ring to make it leakproof, the use of transparent plastic instead of the original colored plastic, and the addition of a sounding line to gauge the depth of insertion.

FDA stated that these changes required the submission of a 510(k) because they could significantly affect the device's safety and efficacy. I believe industry generally disagrees with FDA and would question the rationale the agency used to reach this conclusion. If FDA intends to apply the document in the manner described, its use could adversely affect patients, manufacturers, and the agency itself.

FDA's first contention, that adding an O-ring is a significant change and thus justifies the submission of a 510(k), is wrong. It is the manufacturer's responsibility to evaluate the material used in and the design of the O-ring to ensure its suitability for use. After doing so, the maker has established that the O-ring presents no new risk and does not significantly affect safety or efficacy. Moreover, the company has been manufacturing and marketing the device for over 20 years, so it should possess the knowledge and experience to make intelligent incremental improvements. A 510(k) should not be required for this change.

Secondly, FDA argues that changing the material that comes in contact with body tissue and adding a sounding line warrant the submission of a 510(k). In the normal course of doing business, a manufacturer would evaluate a material for its suitability for use, including its reaction to sterilization. Switching to transparent plastic is probably to allow users to view the aspirated fluids. If a known material that conforms to a recognized standard is used, the change can be considered insignificant. It most likely would not affect the device's safety or efficacy. Such a change shouldn't require a 510(k) submission.

No good decision can be made concerning the need for a 510(k) in this example by debating the technicalities of the guidance document. A good decision can be made by using common sense. Essentially, this device is the same one with the same intended use as the device distributed commercially by the same company for more than 20 years. It is not a new device. What public benefit would be derived from a 510(k) for the changes made to it? Aren't there other truly new devices with unknown risks competing for the resources that would be exhausted on a submission for the changes to this device?

The guidance document removes common sense from decision making. This example shows how the guidance can be used to justify a 510(k) submission for even the most trivial changes to a device. A major orthopedic device company may manufacture as many as 50,000 separate items, to which it makes hundreds of engineering changes over the course of a year. If most of those changes were to require 510(k)s, thousands of additional submissions would be added to FDA's workload. Moreover, it would discourage manufacturers from making incremental device improvements that benefit patients and users.

Orthopedic device manufacturers fear a return to the days of 1993 when hundreds of 510(k) submissions were backlogged at FDA. Total elapsed review times were as long as 18 months for orthopedic devices.

FDA reform legislation is needed to provide flexibility and encourage the use of common sense in the regulatory process. New legislation should point FDA resources toward matters presenting the highest actual risks to the public health. It should also minimize FDA activities that exhaust resources in order to control speculative and insignificant risks.

In the end, how FDA applies this new guidance will determine whether it floods itself with 510(k) submissions for trivial changes to devices.

Lonnie Witham
Orthopedic Surgical
Manufacturers Association
Warsaw, IN

FDA replies:

FDA's recently issued guidance provides the agency and industry a common ground for determining when to submit a new 510(k) for changes to an existing device. The agency recognizes that manufacturers make many changes to their devices each year and often question whether to submit new 510(k)s.

While developing this document, FDA received comments from industry and other groups as well as responses to a notice published in the Federal Register in the fall of 1995. The agency's goals were to eliminate the submission of unnecessary 510(k)s for trivial changes and to provide a mechanism for identifying those changes that could significantly affect safety and effectiveness.

The guidance stresses three basic premises:

  • Manufacturers must determine whether a new 510(k) is needed for the planned change.
  • Each change must be evaluated individually, using a series of flowcharts (i.e., labeling, performance, and materials flowcharts).
  • Industry can contact the agency if it needs further guidance or clarification.

The example used in MD&DI's Help Desk column gives little information about the aspirating device and does not provide its indications for use. Without this information, it is difficult to determine the need for a new 510(k).

How a change affects a device's safety and effectiveness varies greatly according to a device's indications for use. For example, modifying an aspirating device used at the skin's surface is different from changing a preamendment device so it can be used for aspirating through an endoscope (a possibility with the addition of the sounding line and O-ring). Another variable is whether the device is to be used to aspirate blood for reinfusion.

Finally, the type of body tissue contacted by the new material raises other concerns. If the new material will contact body tissues in vivo (requiring additional testing according to ISO 10993-1), the manufacturer would need to submit a new 510(k). The manufacturer then needs to evaluate the affect of these changes using the technology/performance flowchart of the guidance document. If the new material will not directly contact body tissues in vivo, and the aspirated fluids are not returned to the patient, then the manufacturer needs to determine whether the material change will affect device performance specifications.

FDA is currently working to reengineer the 510(k) process. We are analyzing design controls under the new quality system regulation and how they may affect the need for future 510(k)s. Additionally, the 510(k) reengineering team is considering the following:

  • Identifying additional device categories for exemption from 510(k)s.
  • Relying on conformance with recognized consensus standards, guidance documents, and other special controls to reduce the amount of information contained in 510(k)s.
  • Using third-party organizations to function as surrogates for FDA in the review of 510(k)s.

The agency wants to expend its limited resources on those activities that provide the most public health value to industry and the public.

Heather Rosecrans
Program Operations Staff
Office of Device Evaluation, CDRH, FDA
Rockville, MD

Copyright ©1997 Medical Device & Diagnostic Industry
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