| The long awaited final guidance, issued July 8, | | | | - if the file is not complete, a RTF, a refusal to file |
| 2010 by CDRH/ODE, for HDE Holders, Institutional | | | | will be issued and the file returned to the |
| Review Boards (IRBs), Clinical Investigators and | | | | submitter |
| FDA Staff is now available to interested parties. | | | | - if the file is incomplete and a RTF is issued with |
| The last updated draft was issued August 5, | | | | a request for additional information, the clock |
| 2008 and a previous regulation was issued July 18, | | | | re-starts, the 75-day period is reset |
| 2006. This document supersedes all others. The | | | | - the review time for amendments, supplements |
| guidance provides application and clinical submission | | | | and additional reports is 75 days |
| information pertaining to Humanitarian Device | | | | - HDE amendments, supplements and additional |
| Exemption for Humanitarian Use Devices (HUDs) | | | | reports are subject to the same regulations as |
| authorized by FDA 510(m)(2) and sets forth | | | | PMAs |
| additional requirements for Pediatric Device Safety | | | | - there are no user fees due FDA for the filing |
| and Improvement. | | | | - QRS regulation applies and is focused on |
| An HDE is an application guided by 21 CFR | | | | manufacturing processes relevant to the safety |
| 814.3(n), for medical devices for intended use that | | | | of the device |
| will benefit "in the treatment or diagnosis of a | | | | - an exemption from QRS regulation may be |
| disease or condition that affects or is manifested | | | | requested and considered. |
| in fewer than 4000 individuals in the US per year". | | | | An HDE may be regulated by CDRH or CBER or |
| The HDE is similar to the premarket (PMA) | | | | both. The first step, when considering a clinical |
| approval application, but does not require | | | | application or a clinical submission for HUD or HUD |
| effectiveness requirements as described in the | | | | "Exemptions" is to determine which review division |
| guidance. Medical HUDs cannot be sold for profit | | | | and center the file will be submitted. QC must be |
| and only can be used for its intended use under | | | | used to ensure file-ability, completeness of |
| the approved direction of an IRB, except in | | | | components and to ensure quality of data and |
| certain emergencies described in the guidance. | | | | documentation, ensure previous submitted |
| The guidance provides distinction on when a HUD | | | | consistency in file content and regulatory |
| can be "used" vs. "investigational use" / "clinical | | | | compliance. |
| investigation". | | | | HUDs and HDEs are meaningful to patients who |
| FDA Considerations: | | | | fall into a "special" small, treatable and/or |
| - FDA will approve or deny HDE applications 75 | | | | diagnosed disease and/or emergent situation. |
| days from the date of receipt | | | | These applications, as well can be used as |
| - a 30 day filing period starting at the file date, will | | | | strategic "planning" tools. |
| be used by FDA to determine "completeness" | | | | |