FDA Issues Three Draft Guidances on Medical Devices

January 3, 2012—The US Food and Drug Administration (FDA) has issued draft guidance documents on medical device classification product codes, complaints or appeals of medical device decisions, and evaluating substantial equivalence in premarket notifications in the 510(k) program.

According to the agency, the purpose of the draft guidance regarding medical device classification product codes is to educate regulated industry and FDA staff on how, when, and why to use classification product codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research.

This document describes how classification product codes are used in a variety of FDA program areas to regulate and track medical devices. This document is limited to medical devices as defined in section 201(h) of the Federal Food Drug & Cosmetic Act and does not discuss classification product codes used to regulate nonmedical electronic radiation-emitting products. The scope of this document includes devices described in the existing classifications under the Code of Federal Regulations Title 21 Parts 862 to 892. It also describes how the product code builder developed by the FDA's Office of Regulatory Affairs is used for devices that are licensed under the Public Health Service Act and currently do not have product codes generated under classification regulation panels. It also covers unclassified devices and devices that are not yet classified.

The second FDA draft guidance document describes the processes available to outside stakeholders to request additional review of decisions and actions by the FDA's CDRH employees. When finalized, this guidance will supersede “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” dated February 1998, and “Resolving Scientific Disputes Concerning the Regulation of Medical Devices, a Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA,” dated July 2001.

According to the agency, individuals outside of the FDA who disagree with a decision or action taken by the CDRH and wish to have it reviewed or reconsidered have several processes for resolution from which to choose, including requests for supervisory review of an action, petitions, and hearings. These processes are broadly described in FDA regulations. The draft document provides general information about each process, as well as guidance on how to submit related requests to the CDRH and FDA.

The third draft guidance for industry and FDA staff addresses  the 510(k) program and evaluating substantial equivalence in premarket notifications.

According to the FDA, when final, this document will supersede “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3,” dated June 30, 1986, and “The New 510(k) Paradigm—Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications,” dated March 20, 1998.

The FDA stated that this draft document was developed to provide guidance to identify, explain, and clarify each of the critical decision points in the decision-making process the FDA uses to determine substantial equivalence. The agency advised that this draft guidance is not intended to implement significant policy changes to the current 510(k) review process. Rather, its intent is to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying the FDA's 510(k) review. This guidance also updates the FDA's policies with respect to the Special 510(k) program.

The agency advised that its guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word should in agency guidances means that something is suggested or recommended but not required.