Regulatory Authority

Food and Drug Administration (US FDA)



Quality system

A Quality System compliant with 21 CFR P art 820 et alter is required. Considering that, compared to previous versions of the same standard, the requirements of the latest version of ISO 13485:2016:2016 are closer to the Quality System Regulations (QSR), FDA has expressed its intention to harmonize the QSR with international requirements, thus transitioning from QSR – 21 CFR 820 to ISO 13485:2016:2016. The United States participate in the MDSAP Program (Medical Device Single Audit Program) together with Brazil, Canada, Australia and Japan.

In order to be marketed in the United States, all Medical Devices must be registered with the FDA. Manufacturing facilities are subjected to FDA inspections to ensure compliance with the American GMP requirements. In addition, each establishment where production, distribution, import and marketing of Medical Devices are performed in the U.S.A. must be disclosed and registered at the FDA, through Establishment Registration, in accordance with 21 CFR 807.


Although some Class I devices are exempt from most QSR requirements, it is necessary to implement a Quality Management System (QMS) that conforms, at least partly, with 21 CFR 820. Even in the case of Class I devices that are exempt, the QMS must comply with the requirements of 21 CFR 820.180 (Record Keeping) and of 21 CFR 820.198 (Complaints File). As soon as the fees for the Establishment Registration are paid, the manufacturer can complete the device listing online process the for its Class I device.


Require the implementation for a QMS compliant wtih 21 CFR 820. Clinical studies are required for innovative devices, thus it is important to get feedback from the FDA as early as possible by submitting a Pre-Submission (Pre-Sub) request. Subsequently, for devices that require clinical trials, it will be necessary to submit an application for Investigational Device Exemption (IDE) to allow the collection of data on the safety and efficacy of: implantable devices, devices that support and sustain vital functions, devices that play a fundamental role in the diagnosis, treatment and prevention of diseases, devices that present a potential risk to the health, safety and well-being of the subject. The preparation of the dossier for the IDE also involves the development of a protocol for the clinical study. For Class II Medical Devices that do not require clinical studies it will be necessary to prepare and send the 510(k) Premarket Notification and pay the related fee. FDA does not issue a certificate, but sends a letter that is published online (Marketing Clearance).


It is necessary to implement a 21 CFR 820-compliant QMS. To obtain the marketing approval, it is necessary to submit an application for a Premarket Approval (PMA) and a pay fee. Based on the data provided by the manufacturer, FDA must determine whether the PMA contains valid and sufficient scientific evidence to ensure that the device is safe and effective for the intended uses. Moreover, FDA inspects all the operators involved in the design and production phase of the device to ascertain the compliance of the QMS with the QSR. Finally, if the PMA application is successful, FDA will communicate its approval for marketing the device. Each yearly quarter, FDA publishes the approved PMAs in the Federal Register. After obtaining the marketing approval or clearance from the FDA, each manufacturer must register their establishment through Establishment Registration, perform the Device Listing of devices marketed on the U.S. market and comply with the American GMPs. The Establishment Registration and the Device Listing entail the obligation for the manufacturer to designate a U.S. Agent and indicate the references of a device importer (U.S. Initial Importer).


The manufacturer. Foreign manufacturers who intend to market their Medical Devices in the United States must appoint a U.S. Agent, meaning a Local Representative responsible for communications with the FDA.

Timeframe and fees

The approval times vary depending on the device classification: Class I: 1 month Class II: 4-8 months Class III: 18-30 months. In accordance with MDUFA IV of 2017, every year the FDA publishes the list with the updated fees for medical device registration procedures. The most recent one, Medical Device User Fees for Fiscal Year 2020 has been published on August 1, 2019. The updated amounts refer to all the applications submitted to the FDA after October 1, 2019 and by September 30, 2020.


Device registration: unlimited as long as there are no substantial changes to the device. Establishment Registration and Device Listing: annual renewal (from October 1st to December 31st).

Labelling and documentation language

Documentation and labelling must be provided in English. The labelling must comply with 21 CFR 801 (approved by the FDA during the device registration process).

Useful information

In compliance with 21 CFR 801.20, all Medical Devices marketed in the United States must bear an UDI (Unique Device Identification) code. The UDI system was implemented as follows:

UDI on the label and packaging Compliance date
Implantable, life-supporting, and life-sustaining devices September 24, 2015
Class III Medical Devices September 24, 2014
Class II Medical Devices September 24, 2016
Class I and unclassified devices manufactured and labeled on or after September 24, 2018 No sooner than: September 24, 2022
UDI Direct Mark (permanent marking on the device itself, reprocessed device) Compliance date
Implantable, life-supporting, and life-sustaining devices September 24, 2015
Class III Medical Devices September 24, 2016
Class II Medical Devices September 24, 2018
Class I and unclassified devices manufactured and labeled on or after September 24, 2018 No sooner than: September 24, 2022

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