Contract Manufacturers and Contract Sterilizers Must Now Register and List Under New FDA Regulations; Foreign Establishments Also Affected by New Rule

By Carmelina G. Allis –

On August 2, 2012, the FDA published a final rule amending its regulations in 21 C.F.R. Part 807 to reflect the 2007 statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act ("FDC Act").  This final rule also facilitates the FDA’s collection of additional registration information in order to comply with the 2002 Bioterrorism Act.

The most significant change is that all contract manufacturers and contract sterilizers must now register and list.  This change eliminates the long standing exemption for contract manufacturers and sterilizers who performed these activities for another party who both initiated the specifications and commercially distributed the device.  77 Fed. Reg. 45,927, 45,941 (Aug. 2, 2012) (amending 21 C.F.R §§ 807.20(a)(3) and (c)(1) to remove this exemption).

The usual registration user fee will apply.  The FY 2012 establishment registration fee is $2,020.  In FY 2013, the fee will be $2,575 (see our previous post here).

There also are new requirements for foreign establishments to identify all known importers and to register/list even when their devices enter a foreign trade zone.  According to FDA, these requirements will comply with the Bioterrorism Act, and help increase the Nation’s ability to prepare for an respond to acts of bioterrorism and other public health emergencies.

The regulation also has been revised to require that all registration and listing information be submitted electronically to FDA (absent a waiver).  This formally implements the 2007 statutory amendments, although FDA in fact has been requiring electronic regulation for several years now.

The effective date of the final rule is October 1, 2012.