Regulatory Update: New FDA Requirements for Contract Manufacturers
By Angela Mallery
On October 1, additional burdensome regulatory hurdles were placed on medical device contract manufacturers.
Contract manufacturers now are required to electronically file an establishment registration and pay a yearly fee (fiscal year 2013: $2,575) to the U.S. Food and Drug Administration (FDA, absent a waiver). Requirements also have been added that require contract manufacturers to list all currently commercialized proprietary and common names of the devices they manufacture.
Beginning October 1 this year, all device establishments (including contract manufacturers) must complete their annual registration for each fiscal year between October 1 and December 31.
There has been a long standing registration and listing exemption for contract manufacturers of a finished device that was manufactured to another establishment’s design and did not put the device into commercial distribution. On August 2, to comply with the 2002 Bioterrorism Act, the FDA published the revised version of part 21 CFR 807
requiring contract manufacturers to register their establishment and list their devices with FDA.
The new device registration and listing requirements affects domestic and international medical device contract manufacturers, in addition there are requirements for contact sterilizers, initial importers, establishment that only handle complaints, and existing manufacturers. Fortunately, this does not apply to devices under investigational device exemptions, other exemptions can be found under 21 CFR 807.65
Some of the hurdles that need to be managed include:
• How does a manufacturer ensure that its existing contract manufacturers are in compliance with the new device registration and listing requirements?
• How does a contract manufacturer ensure it is in compliance with listing all the proprietary names the device is commercialized under, and as an initial importer of devices?
• How can they ensure their information on devices and manufacturers are up to date?
For additional information who must register, how to register, list and pay fees for medical device establishment registrations and listing refer to FDA’s August 2 letter
Angela Mallery is a regulatory consulting manager in the Minneapolis, Minn., office of NAMSA.