The Medical Devices Introductory Course 2020

Establishment Registration & Device Listing

• All establishments (US and foreign) involved in the design (specification development), production and distribution of medical devices intended for commercial distribution in the US are required to register annually

• Includes contract manufacturers and sterilizers

• Registration identifies the “Owner Operator” of the establishment and US Agent (for foreign establishments)

• Establishments are required to list all the devices (irrespective of class) that are designed, manufactured or imported / distributed from the facility and the activities that are performed there

• Registration requires payment of annual fee: $5,236 (Fiscal Year: 2020)

• Annual registration must be completed online via FDA electronic database (“FURLS”) between 1 October and 31 December

Post-Market Activities

• Quality System Regulations [21 CFR 820] o Apply to all class II/III and some class I devices

o Subjects manufacturers (registered establishments) to FDA inspection o Requires document controls, change control, CAPA processes, etc • Medical Device Reporting [21 CFR 803] o Applies to all devices and requires electronic reports on specified forms o Reportable when device may have caused or contributed to death or serious injury and/or when device malfunctions o Reporting timeframes: 5 days / 30 days after become aware • Labelling Requirements [21 CFR 801] o Apply to all devices o “ Labeling ” relates to advertising as well as package / device labels and pack inserts (instructions for use / user manuals) o Unique Device Identification (UDI) marking • Recalls [21 CFR 806]

o Covers market withdrawals and corrections o Reporting requirements and recall classification