Device Establishment Registration and Listing in line with the FDA’s Proposed Rule

Annual registration is a requirement for any device firm, establishment or facility whose business relates to the production and distribution of medical devices intended for use in the US in some or another way.

Such business establishments have to register with the FDA and also need to list the devices that are made there and the activities that are performed on those devices. The FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and device listing, under what is called the Proposed Rule.

Four proposed changes

There are four types of changes to the FDA’s device establishment registration and device listing regulations that the Proposed Rule contains:

–       Amending the FDA’s current regulations to align them with the provisions of the 2007 FDA that relates to electronic device establishment registration and listing, many of which the FDA has already implemented

–       Requiring establishments to provide certain information that FDA currently requests when the establishment registers or lists a device, a non-mandatory requirement

–       Amending the regulations to expedite the FDA’s collection of information from foreign establishments about their devices that are imported into the US as required by the 2002 Bioterrorism Act and other proposed changes to be addressed

–       Requiring establishments to provide additional or different information from that specified in the current regulations, but which FDA now requests via FURLS.

Familiarization with the Proposed Rule

A webinar that is being organized by Compliance4All, a highly popular provider of professional trainings for all the areas of regulatory compliance, will offer insights into these aspects. David Dills, Global Regulatory Affairs & Compliance Consultant, who has an accomplished record with more than 26 years of experience within Regulatory Affairs, will be the speaker at this webinar. Please log on to http://www.compliance4all.com/control/w_product/~product_id=500835LIVE/~sel=LIVE/~David_Dills/~FDA’s_Proposed_Rule_Regarding_Device_Establishment_Registration_and_Listing_and_How_to_Register_and_List to enroll for this webinar.

This webinar will provide latest update as well as refresh participants’ knowledge of how to register their device company and list their device(s) correctly and meeting requirements and expectation, no matter what the outcome of the Proposed Rule.

David will cover the following areas at this webinar:

o  When and how to register and list

o  Review the four proposed changes to FDA’s device establishment registration and device listing regulations

o  Proposed changes to implement the provision of Bioterrorism Act applicable to imported devices

o  Other proposed amendments that would change current device establishment registration and listing requirements

o  Replacement of the current regulations regarding updating device listing information outside the required update periods

o  Clarification of who must provide establishments’ registration numbers

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