United States Medical Device Regulations
Regulatory Agency
The U.S. Food and Drug Administration (FDA) regulates medical devices to ensure their safety and effectiveness before they reach the market. eSTAR (Electronic Submission Template and Resource) is an interactive submission tool designed to streamline and standardize the application process for medical device approvals, improving efficiency and compliance with FDA requirements.
Medical Device Definition
Medical Device: is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or another similar or related article, including a component part or accessory which is:
- Recognized in the official National Formulary, the United States Pharmacopoeia, or any supplement to them
- Intended for use in the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, in man or other animals
- Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals
It does not achieve its primary intended purposes through chemical action within or on the body of man or other animals. Therefore, it is not dependent upon being metabolized to achieve its primary intended purposes.
Medical Device Classification System
| International Classification | Risk Level | Examples |
|---|---|---|
| Class I | Low Risk | Tongue depressors, bandages, and hand-held surgical instruments |
| Class II | Moderate Risk | Wheelchairs, pregnancy test kits, and certain types of pacemakers |
| Class III | High Risk | Implantable pacemakers, breast implants, and heart valves |
Regulatory Approval Process
Classification |
Approval Procedure |
|---|---|
Class I |
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Class II |
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Class III |
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Notes: The applicant is required to have a quality management system (QMS) compliant with 21 CFR 820, in place that complies with the FDA’s Quality System Regulation (QSR). However, class I devices are exempt from QMS compliance. It is important to get feedback from the FDA as early as possible by submitting a Pre-Submission (Pre-Sub) request. 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). |
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Additional Information
Approval timeline |
Class I:- 1 Month, Class II:- 4-8 Months, Class III:- 18-30 Months |
License validity period |
Device registration: unlimited as long as there are no substantial changes to the device. |
Fees |
510(K) :- $24,335 (For small business:- $6,084) PMA :- $540,783 (For small business :- $135,196) De novo classification request :- $162,235 (For small business :- $40,559) |
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