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Invitation to Preparers of Abbreviated 510(k)s for Selected Devices

FDA is inviting preparers of Abbreviated 510(k)s for selected devices to develop their Summary Reports interactively with the review division

In "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications; Final Guidance" (www.fda.gov/cdrh/ode/parad510.html), FDA presented alternatives to the traditional 510(k) for demonstrating substantial equivalence that would streamline the preparation and review processes for this type of marketing application. In the Abbreviated 510(k) option, manufacturers may rely on guidance documents, special controls, or recognized standards. If you are submitting an Abbreviated 510(k) that relies on a guidance document and/or a special control, you should include a summary report that describes how the guidance and/or special control were used to address the risks associated with the particular device type.

In addition to the above-described use of special controls, the agency recently released special control guidance documents for ingestible gastrointestinal imaging systems, automated differential cell counters, and indwelling blood gas analyzers. In these guidances, the risks associated with the specific device type were identified as well as the agency's recommendations for addressing them. FDA believes that the use of such guidances will help to significantly reduce regulatory burden while still ensuring that the risks associated with the device are adequately addressed.¹

FDA is inviting preparers of Abbreviated 510(k)s for certain types of devices to develop their summary reports interactively with the review division. As discussed in the guidances listed below, a summary report should contain the information that FDA has described in a special controls guidance document or acceptable alternative information that addresses the identified risks, to support a substantial equivalence determination for these device types.

In addition to the five device types mentioned above for which we have issued final guidances, we are also listing three device types for which we have issued draft special control guidances. The agency is encouraging manufacturers of any of these eight types of devices to participate.

• Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1126.html.

• Class II Special Controls Guidance Document; Ingestible Telemetric Gastrointestinal Capsule Imaging System; Final Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1385.html.

• Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1184.html.

• Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1328.html.

• Class II Special Controls Guidance Document: Endolymphatic Shunt Tube with Valve; Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/791.html.

• Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Draft Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1378.html.

• Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1335.html.

• Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments; Draft Guidance for Industry and FDA,
  http://www.fda.gov/cdrh/ode/guidance/1389.html.

By working interactively with the review division to develop a template for 510(k) summary reports for certain types of devices, industry will be able to provide direct input on the format, thus increasing the likelihood that the manufacturer will be satisfied with the end result. In addition, once FDA describes the appropriate content for specific types of summary reports, industry should be able to reduce its preparation time for Abbreviated 510(k)s for these device types.

FDA will benefit from the technical experience of the manufacturers of these devices to help ensure that the agency identifies adequate and appropriate methods of addressing the risks associated with these products. Industry may be able to provide alternative methods of addressing the risks that the agency had not previously considered or provide advice on the acceptance criteria to apply. FDA should be able to reduce its review time for these summary reports after templates are developed and disseminated among submitters and reviewers.

Contact Ann Hawthorne at (301) 594-1190 or by e-mail to cxh@cdrh.fda.gov.

Updated 5/28/02

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