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	Premarket notification is not required for most class I devices. GMP:- Mostly exempt from current device good manufacturing practices. However, must comply with other regulatory controls. If the device is not exempt, 510k will be required for marketing.
Class II	Most class II devices are exempt from the premarket notification, If required, an applicant must complete 510(k) Premarket notification. The De Novo application is required For Novel devices.
Class III	The applicant must require to complete the premarket approval process (PMA)
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).

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)