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United States Medical Device Regulations

Agency
The US Food and Drug Administration (FDA) regulates medical devices in the United States.
Medical Device Definition
A medical device in the United States 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
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.
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) :- $19,870 (For small business:- $4967) PMA :- $441,547 (For small business :- $110,387) De novo classification request :- $132,464 (For small business :- $33,116)
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