The FDA Center for Devices and Radiological Health (CDRH) has published a SOP to describe how manufacturers should be informed in the future about new or modified requirements/expectations by use of "Notices to Industry" Letters.
A working group of the CDRH has observed that in the medical devices industry, communication about new findings or changes - which influence clinical trials or premarket applications of devices - often happens too late and often in an individual way (e.g. through the reviewer of a premarket application).
In order to improve this situation and to communicate faster, the CDRH working group has recommended publishing so-called "Notice to Industry". This could be "Notice to Industry Guidance Letters", which implicate new guidelines or regulatory interpretations.
In urgent cases - under 21 CFR 10.115 (g) (2) - a "Level 1 - Immediately in Effect Guidance Document" could also be issued. Besides, "Notice to Industry Advisory Letters" can be sent to communicate new scientific information which has no direct connection to regulatory aspects. Following the issuance of a "Notice to Industry" Letter, a more in-depth notification is made in the "Federal Register".
The SOP describes very precisely the "Notice to Industry" process in 5 steps. Step 1 only presents the initiate development of a "Notice to Industry Letter". Step 2 deals with the draft of a "Notice to Industry" Letter which has to comply with two templates attached in the SOP: Attachment 1 is for the "Notice to Industry Advisory " Letter " and Attachment 2 for the "Notice to Industry Guidance" Letter: Level 1- Immediately in effect guidance. In step 3, the draft is reviewed and cleared. A so-called "Notice of Availability" (NoA) is issued too. This NoA will be published in the Federal Register when the corresponding "Notice to Industry" Letter is available on the CDRH website. NoAs are published only for "Notice to Industry Guidance" Letters. Step 4 describes the actual issue of a Notice to Industry Letter. Step 5 reviews comments to a "Notice to Industry Guidance" Letter: Level 1 - Immediately in Effect Guidance which are submitted to the FDA.
The document contains 11 pages and the last five are dedicated to the templates mentioned above.
Please see the SOP for further information.
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