Section I: North America: United States and Canada
Chapter 2: Postmarket Compliance: US
26
Table 2-1. Domestic Establishments6
Activity Register Device Listing
Fee
Payment
Manufacturer/remanufacturer and kit
assemblers
Yes
21 CFR Part 807.20(a)
Yes
21 CFR Part 807.20(a)
Yes
Manufacturer of accessories or components
packaged or labeled for commercial distribution
for health-related purposes to an end user
Yes
21 CFR Part 807.20(a)(6)
Yes
21 CFR Part 807.20(a)(6)
Yes
Manufacturer of components, not otherwise
classified as finished device, distributed only to
a finished device manufacturer
No
21 CFR Part 807.65(a)
No No
Custom device manufacturer Yes
21 CFR Part 807.20(a)(2)
Yes
21 CFR Part 807.20(a)(2)
Yes
Refurbishers or remarketers of used devices
already in commercial distribution in the US
No No No
Repackagers/relabelers Yes
21 CFR Part 807.20(a)(3)
Yes
21 CFR Part 807.20(a)(3)
Yes
Contract manufacturers (including contract
packagers)/contract sterilizers
Yes
21 CFR Part 807.20(a)(2)
Yes
21 CFR Part 807.20(a)(2)
Yes
Specification developers Yes
21 CFR Part 807.20(a)(1)
Yes
21 CFR Part 807.20(a)(1)
Yes
Reprocessors of single-use devices Yes
21 CFR Part 807.20(a)
Yes
21 CFR Part 807.20(a)
Yes
Initial importers Yes
21 CFR Part 807.40(a)
No
Identify manufacturers per
21 CFR Part 807.20(a) (5)
Yes
Device under IDE investigation No No
21 CFR Part 807.40 (c)
No
Domestic distributor (that does not import
devices)
No
21 CFR Part 807.20(c)
No No
Any establishment located in a foreign trade
zone involved with the manufacture, prepara-
tion, propagation, compounding, assembly, or
processing of a device intended for commercial
distribution in the US
Yes
21 CFR Part 807.40 (a)
Yes
21 CFR Part 807.40 (a)
Yes
Import agent, broker, and other parties who do
not take first possession of a device imported
into the US
No No No
Specification consultant No No No
US manufacturer of “export only” devices Yes
21 CFR Part 807.20(a)
Yes
21 CFR Part 807.20(a)
Yes
Wholesale distributor that is not a manufac-
turer or importer
No No No