New Establishment Registration and Device Listing Rule - August 2012

[MIREGMGR]

There's no mention of a forthcoming guidance or a full explication of the revised rules in the advisory letter, even though that letter describes the information it contains as a summary.

It however does say:

If you have any questions or need assistance regarding registration and listing, please contact the Centers for Devices and Radiological Health (CDRH) Registration and Listing Helpdesk by email at reglist@cdrh.fda.gov.

[Ronen E]

Maybe some additional information / clarifications can be found here:

http://www.fda.gov/MedicalDevices/De...ce=govdelivery

Either way, the FR publication which I linked to has a preceding discussion which may shed some light.

[MIREGMGR]

I spoke with FDA today and learned two bits of information:

1. No guidance will be forthcoming before October 1, when the program commences.

(As a side point, I think a post earlier in the thread says that this is due October 1...not so, October 1 is the earliest you can Register and List for FDA year 2013, with December 31 being the last day for such activity before penalties and regulatory actions could apply.)

2. Outside-US Contract Manufacturers always have been required to Register and List. Under the new system, outside-US sterilization and packaging subcontractors also will be required to Register and List.

[Marc]

Also see: Medical Device Establishment Registration and Listing - Notice of Changes for FY 2013

[Ronen E]

Here's some support(?):

http://www.fda.gov/MedicalDevices/De...ce=govdelivery

[ariannas]

In Reply to Parent Post by Michael Malis

There are still a lot of questions around this issue. Does anyone know if FDA plans to provide additional guidance?

This may not count as official guidance, but I did pick up the attached presentation from the REDI conference that I attended yesterday. It covers the FDASIA changes and also gets into the two systems (one for payment and the other for the actual listing) that have to be used to register.

The file name is my own invention, not the FDA's

[MIREGMGR]

My analysis of the presentation above is that it's a survey of the basics, and doesn't provide any information that advanced FDA regulatory folks wouldn't already have known from the prior rules and practices plus the original disclosure of the 2013 plans.

It's useful to know that FDA hasn't sorted this stuff out to the point where a presentation like this wouldn't contain some new details of the sort that Michael Malis asks about.

[Sam Lazzara]

What if you are an FDA registered Manufacturer and your Contract Sterilizer is FDA registered but does not specifically list your devices that they process? How concerned would you be about this?