FDA Approval for Medical Products and Devices
*Overview of FDA Approval Process for Medical Products and Devices:
For getting the FDA Approval for Medical Devices and Products, the following process has to be followed:
I. Identifying your Device's Classification
Medical devices fall into three classes:
- Class I
- Class II
- Class III
The class of the device will correlate to how you'll need to manage requirements and testing. The class of device will also determine the regulations that you will need to comply with. The Class I medical devices are the lowest risk. So, they are generally not subject to a Premarket review. However, Class II and Class III devices are subject to Premarket reviews. Most Class II devices require Premarket Notification 510(k), and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at - https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device.
II. Developing a Prototype
The main use of developing a prototype is for testing in laboratory environments and sufficiently reducing risk before it is used by humans. It may then go to clinical trials.
III. Submitting the Applications (If Applicable)
To get FDA clearance to market and distribute your Class II or Class III device, you'll need to submit a Premarket notification or application. As part of this, you will need the FDA verification and validation of your device. FDA verification is vital for ensuring that the requirements you had set are fulfilled. FDA Validation is imperative for making sure the device you deliver fulfills the needs of the market.
IV. Waiting for FDA Review and Approval
The next step is to wait for the FDA to review and approve your device.
V. Maintaining FDA Compliance
Even after receiving the FDA approval, you have to ensure your device stays in compliance for its lifespan.
*Detailed Approval Procedure:
The process of seeking approval is as follows:
1. Decide the classification of your device by examining the FDA classification database using relevant search terms or by distinguishing another device with the equivalent planned use and innovation. Grant special attention to the three-letter Product Code and seven-digit Regulation Number related to the predicate devices you recognize. If the order can't be resolved, then use 513(g) to appeal classification from the FDA.
2. Most Class I devices have to consent to the QSR (GMPs), aside from Part 820. For Class II and III devices, execute the Quality Management System (QMS), which meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820. Innovative Class II, and all Class III, devices will probably require clinical investigations. Get 'Pre-Submission (Pre-Sub)' input from the FDA.
3. If the clinical examination is required, apply for an Investigational Device Exemption (IDE). Develop clinical trial agreements and conduct studies.
4. For Class II devices, plan and submit 510(k) Premarket Notification application and pay the related charge. For Class III devices, get ready, and submit the Premarket Approval (PMA) application. Pay PMA submission expense.
5. For Class III devices, FDA conducts facility investigations of every major supplier associated with the design and production of your device. All parties must be consistent with FDA QSR.
6. For the Class II devices, the FDA issues a 510(k) clearance letter and posts it online. And for Class III devices, the FDA issues the PMA approval letter and posts it online.
7. As of now, you should be in full consistency with QSRs. The FDA will not examine Class I or II device manufacturers for compliance before device registration but conducts unplanned inspections and can issue a Form 483 for non-compliance.
8. If you have no local presence in the US, name an FDA US Agent representative as a local point of contact with the FDA.
9. List your device and register your company utilizing the FDA Unified Registration and Listing System (FURLS) framework on the FDA website as per 21 CFR Part 807. Pay charges for Establishment Registration and Listing, which must be renewed every year.
10. You are currently ready to move your gadget to the US. Your organization and device registration status will be recorded on the FDA website. Your approval does not lapse as long as no changes are made to the device design, intended use, and so on.
*List of Documents for FDA Approval of Medical Devices and Products:
- Acceptance Checklist for Traditional/Abbreviated/Special 510(k) Checklist
- Premarket Notification Class III Certification as may be required by 21 CFR 807.94
- Premarket Notification Truthful and Accurate Statement as required by 21 CFR 807.87(l)
- Premarket Notification 510(k) Statement (as required By 21 CFR 807.93)
- Exempt Device Review Form
- 510(k) Cover Sheet Memorandum
- 510(k) 'Substantial Equivalence' Decision Making Process
- Indications for Use
- Required Elements for a Declaration of Conformity to a Recognized Standard
*Fee/Cost of Services Offered by FDA concerning Medical Devices:
- Establishment Registration, US Agent/Official Correspondent - USD 449.00 (Annually)
- Device Listing for Additional Device - USD 50/device
- Label Review - USD 649/device
- FDA Registration Fee - USD 5546.00
*Mode of Application:
Both Hardcopy and E-copy