New FDA Draft Guidance for Custom Device Exemptions

In July of 2012, the the Food and Drug Administration Safety and Innovation Act made some changes to the custom device exemptions portion of the FDCA, Food, Drug and Cosmetic Act (Section 520(b)).  The changes cover devices created or modified for a custom order for a physician or dentist, or devices with an annual distribution of 5 units or less.   This can be referred to as “compassionate use” exemptions.  Now there’s a new Draft Guidance document with more details on how the FDA plans to implement these changes.

The document, “Custom Device Exemption; Draft Guidance for Industry and Food and Drug Administration Staff,” is 22 pages.  It has a definitions section and a Q&A section that includes some examples of custom devices.  And since the Safety and Innovation Act added a new reporting requirement for these custom device exemptions, there are 7 pages devoted to this annual report.

For your information, the text of section 520(b) of the FDCA is included.  And you’ll also find the 3 Appendices to be quite valuable.  The first provides you with the format for summary data tables.  The second covers the “Truthful and Accurate Statement.”  And the third is a decision tree for determining if your device qualifies as a “custom device” for the exempt status.

This is a draft document, issued so that the public has a 60 day comment period.  If you have a device that you believe qualifies under this section of the FDCA, you’ll want to review the draft guidance to see how it will affect your device and the reports you submit to the FDA.

If you’re a medical device designer or manufacturer, consider making Document Center Inc. your source for standards.  We have been in business since 1982, providing standards, regulatory documents, and other technical information to customers worldwide.  And we support your use of these documents with superior monitoring and current awareness programs, as well as offering responsive customer service.

You can purchase the standards you need at our web store, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We are here to help you find and maintain the technical information essential to your business.  Make us your Standards Experts!