Text updated on August 2018. The legislative and regulatory provisions are subject to changes and updated by the institutions in charge in the Country they are referred to. The undersigned declines any responsibilities with regards to obsolete or inexact information contained in this document. For further information Disclaimer
Food and Drug Administration (FDA)
I, II, III
A Quality System is required in compliance with 21 CFR part 820 et alter. Please note that ISO 13485:2016 latest version requirements compared to the previous versions of the same standard are quite similar to to the ones required by the FDA Quality System Regulation (QSR) for medical devices.
Each facility where production, distribution, import and marketing operations of medical devices are carried out in the USA must be reported and registered to the FDA, through the “Establishment Registration”.
CLASS I MEDICAL DEVICES
For this type of devices it is necessary to implement a Quality Management System (QMS) complying with the FDA Quality System Regulation (QSR) included in the 21 CFR Part 820 (GMP).
As soon as the fees for the Establishment Registration are paid, the manufacturer will be able to complete the online listing process for a Class I device.
CLASS II MEDICAL DEVICES
For this type of devices it is necessary to implement a Quality Management System (QMS) included in 21 CFR Part 820. In the case of innovative devices, clinical studies are required, so it is important to get feedback from the FDA about Pre-Submission (Pre -Sub). In case clinical trials are required, it will be necessary to request the Investigational Device Exemption (IDE) (necessary for implantable devices, for life-sustaining devices, for devices that play a fundamental role in the diagnosis, treatment and prevention of diseases, devices that pose a potential risk to health, safety and well-being of the subject) or develop a clinical protocol for conducting a clinical study. The next step will be to prepare and submit the 510 (k) Premarket Notification and pay the relevant fee. The FDA does not issue any certificate but sends a letter which is later published online (Marketing Clearance).
CLASS III MEDICAL DEVICES
Implement the Quality Management System (QMS) included in 21 CFR Part 820. Clinical studies are required for all devices of this class, so it is important to get feedback from the FDA about the Pre-Submission. In case clinical trials are required, apply for an Investigational Device Exemption (IDE) or develop a clinical protocol to conduct a clinical study. Prepare the Premarket Approval (PMA) and pay the fee. The FDA conducts inspections on all operators involved in the design and production phase of the device for compliance with the QSR. The FDA does not issue a certificate but publishes an online letter.
Foreign manufacturers shall appoint a Local Representative (US Agent) responsible for communicating with the FDA.
Timeframe and fees:
Approval timeframes vary depending on the device Class: Class I: 1 month; Class II: 4-8 months; Class III: 18-30 months.
The Federal Medical Device User Fee for Fiscal Year 2019 (MDUFAIV) is in force since August 1, 2018 and it relates to the updated amount of fees for the registration procedures for medical devices valid for the 2018-2019 fiscal year.
Device registration validity period: unlimited, provided that no changes are made to the device design.
Establishment registration validity period: annual renewal.
Labeling and documentation language:
Documentation and labeling must be provided in English.
The UDI system has been implemented for Class III devices (September 24, 2014), Class II implantable devices or life-sustaining devices (September 24, 2015), Class II devices (September 24, 2016). As for Class I and unclussified devices the FDA has announced its intention to extend the implementation date from 2018 to September 24, 2020.
United States, Brazil, Canada, Japan and Australia are Member States of the MDSAP ( Medical Device Single Audit Program ).
For more information email@example.com