About Medical Device FDA Registration
IAS has more than 15 years of experience in medical device FDA registration and listing. Establishments such as manufacturers, exporters, and importers of medical devices intended to be sold in the USA must register with the FDA. Those located outside of the USA need to designate an FDA US Agent for better communication between parties.
Steps in US FDA Device Registration
FDA registration and listing is possible only for 510(k)-exempt or 510(k)/PMA-cleared devices.
Step 1: Device Classification
The FDA classifies medical devices based on the risk they pose to the patient (low, medium, high). Identify the product code for your device based on its risk and intended use. There are more than 6,000 product codes available for medical devices in the FDA database; IAS will help the applicant find the appropriate product code.
Step 2: Specific & General Controls
Medical device manufacturers and their supply chain must follow the specific and general controls for their devices during manufacturing, packaging, holding, and processing. Once the product code is found, check whether the device is 510(k)-exempt or not. You can find the appropriate product code and classification in the FDA public database.
Step 3: FDA User Fee Clearance
Each entity required to register with the FDA must clear the medical device establishment registration fee, which the FDA revises every year. The 9-digit DUNS Number is mandatory for every FDA applicant. Through a secured payment gateway, IAS will pay the application fee for successful FDA registration.
Step 4: US Agent (Foreign Establishments)
All medical device manufacturers and their supply chain located outside the US need a US Agent for FDA registration. IAS will assign a US Agent for the applicant as their emergency contact in case of any adverse event arising from the medical device supplied in the US market.
Step 5: User Details
After clearing the FDA user fee, a portal for applicant details is completed — including name, address, point of contact, US Agent, and importer. A unique owner/operator number will be assigned to the applicant.
Step 6: Product Listing
The products covered by the application are listed in the FDA portal; other information such as trade secrets, formulas, and designs is maintained in the IAS archive.
Step 7: Registration Number Assigned
A unique registration number will be assigned to the applicant within 60 days after successful registration. In the meantime, the applicant can use the owner/operator number for their US-based business.
Step 8: Registration Renewal
Usually an establishment has to submit a registration renewal application at least 3 months before expiry. IAS can guide you through this and help with US FDA device re-registration.
Fees and Timeline
IAS charges the following fees:
- Step 1 to Step 4 — US$750 (up to 3 products)
- US Agent Fee — US$600
- US FDA Government Fee — US$5,672
Time frame: less than a week.
Medical Device Classes & Controls
The US FDA classifies devices into three categories:
- Class I — low-risk categories of devices
- Class II — moderate-risk categories of devices
- Class III — high-risk categories of medical devices
General Controls
- Adulteration
- Misbranding
- Device registration and listing
- Premarket notification
- Banned devices
- Notification and repair, replacement, and refund
- Records and reports
- Restricted devices
- Good Manufacturing Practices
Special Controls
- Performance standards
- Post-market surveillance
- Patient registries
- Special labeling requirements
- Premarket data requirements
- Guidelines
With vast experience in the medical industry, IAS professionals assess your management system against the general and specific controls for compliance through various schemes such as ISO 13485, GMP, and 21 CFR 820.
Class I
Devices that are not intended to support or sustain life and which operate in such a way that body contact with the device itself is not expected during its effective lifetime — e.g., powered wheelchairs. All Class I medical devices are subject to general controls under US federal law.
Class II
Devices intended to support or sustain life, or of substantial importance in preventing impairment of human health, and which may present a potential risk of illness or injury — for example, intra-uterine contraceptive devices (IUD). All Class II medical devices are subject to general and special controls under US federal law.
Class III
A Class III device is one that does not achieve its principal intended action by pharmacological, immunological, or metabolic means and which may pose a potential risk to health. This category is broken into three sub-categories:
- Class III devices that are life-sustaining or life-supporting (life support only allowed in an emergency situation where no alternative device is available). Examples include ventilators, pacemakers, and heart valves.
- Class III devices that present more than a minor health risk and which require controls to assure safety and effectiveness — including items for sterilization, cutting, or cauterization; other surgical devices; implantable articles including sutures; and needles used to give injections.
- All Class III devices are subject to PMA (Premarket Approval), an important process of scientific evaluation to ensure the safety and effectiveness of Class III devices.
