Unlocking Success: Navigating Medical Device Registration and Vigilant Post-Market Surveillance in USA

Overview

Bringing a medical device to market in the USA involves navigating a complex regulatory landscape overseen by the Food and Drug Administration (FDA). The FDA’s primary objective is to ensure the safety and effectiveness of medical devices for the American public. This means manufacturers must comply with specific registration and premarket requirements before their devices can be legally marketed and sold.

Here’s a simplified overview of the process:

Medical Device Classification

1. The first step is classifying your device based on its risk level. The FDA categorizes medical devices into three classes: Class I, II and III
2. Establishment Registration and Listing: All manufacturers and initial distributors of medical devices intended for the US market must register their establishments with the FDA annually. This provides the FDA with information about the facilities involved in the device’s production and distribution. Additionally, manufacturers must list the specific devices they make at each establishment.
3. Pre-market Submission: Depending on the device class, you may need to submit a premarket notification (510(k)) or premarket approval (PMA) application to the FDA. Other types of premarket submissions are Investigational Device Exemption (IDE), De Novo and Humanitarian Device Exemption (HDE)
4. Labeling and Post-market Surveillance: Once your device is cleared or approved, you must comply with specific labeling requirements that provide healthcare professionals and patients with essential information about its safe and effective use. Additionally, manufacturers are responsible for monitoring their devices after they enter the market to identify and address any potential safety concerns.

Regulatory Authority

U.S. Food and Drug Administration

The Food and Drug Administration (FDA) is responsible for public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food supply, cosmetics, and radiation-emitting products. It regulates tobacco production, marketing, and distribution to reduce minor tobacco use.

The FDA advances public health by accelerating medical product innovations and providing accurate information on health benefits. It also plays a crucial role in counterterrorism by ensuring food supply security and developing medical products to respond to emerging public health threats.

Link for Regulatory Authority

https://www.fda.gov/

Local Regulation

FDA device regulation

Classification of Medical Devices

Class I, II, III

Listing or Registration Requirements

• 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.
• Class I – Requires the implementation for a QMS compliant with 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.
• Class II – 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. The FDA does not issue a certificate but sends a letter that is published online (Marketing Clearance).
• Class III – 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 pay a fee.

Documents Required for USA Medical Device Registration

• Subpart A – General Provisions
• Subpart B – Procedures for Device Establishments
• Subpart C – Procedures for Foreign Device Establishments
• Subpart D – Exemptions
• Subpart E – Premarket Notification Procedures

Registration Timeline

The approval times vary depending on the device classification:

• Class I: 1 month
• Class II: 4-8 months
• Class III: 18-30 months

Registration Fee

• Annual Establishment Registration Fee: $7,653
• De Novo Classification Request
  • Standard fee – $145,068
  • Small business fee – $36,267
• PMA, PDP, PMR, BLA
  • Standard fee – $483,560
  • Small business fee – $120,890
• Premarket Notification 510(k):
  • Standard Fee – $21,760
  • Small business fee – $5,440
• Registration user fee:  $5546

License Validity

Device registration: unlimited if there are no substantial changes to the device.

Establishment Registration and Device Listing: annual renewal (from October 1st to December 31st).
Fee: $7,653 for FY 2024.

Special Labelling Requirements

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

Additional Comments

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

Medical Device Reporting (MDR)

The FDA receives hundreds of thousands of medical device reports annually, including suspected deaths, injuries, and malfunctions. Medical Device Reporting (MDR) is a post market surveillance tool used to monitor device performance, detect safety issues, and contribute to benefit-risk assessments. 

Mandatory reporters submit reports for adverse events and product problems, while voluntary reports from healthcare professionals, patients, caregivers, and consumers provide critical information for patient safety. The FDA reviews all MDRs, evaluating the total information provided and any supplemental reports. However, MDRs have limitations, such as under-reporting, inaccuracies, and lack of verification of device cause.

Medical device reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients, caregivers and consumers).

Post-Market Surveillance

Section 522 of the FD&C Act allows the FDA to mandate manufacturers to conduct post-market surveillance on certain class II or class III devices. This systematic, scientifically valid collection, analysis, and interpretation of data helps address public health questions about the safety and effectiveness of a device, ensuring the safety and effectiveness of the product.

Who should make this Communication?

• Manufacturer
• Authorized Representative
  

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk