Federal Agencies: 

Environmental Protection Agency (EPA)

• Environmental Protection Agency (EPA)--Regulatory Topics

EPA develops and enforces regulations that span many environmental categories, including toxicology and chemical reporting. 

Food and Drug Administration (FDA)

• FDA--Center for Biologics Evaluation and Research (CBER)

CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products.

• FDA--Center for Devices and Radiological Health (CDRH)

CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions

National Institute of Health (NIH)

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

Essentially, medical devices are subject to the general controls of the Federal Food Drug & Cosmetic (FD&C) Act which are contained in the final procedural regulations in Title 21 Code of Federal Regulations (21CFR) Parts 800 - 1299

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. 

• Most Class I devices are exempt from Premarket Notification 510(k)(with the exception of Reserved Devices)
• All Class II: Premarket Notification 510(k) requires demonstration of Substantial Equivalence (SE) to legally marketed device in U.S. SE means “Substantial Equivalence” or “Just as Safe and Just as Effective”.
  • Search 510(k) database
• Most Class III: Premarket Approval (PMA) requires proof of reasonable assurance of safety and effectiveness.
  • Search PMA Database
• An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application.

There are two methods to determine which class your device may fall under:

1.  go directly to the classification database and search for a part of the device name
2.  browse the device panel (medical specialty) to which your device belongs

Device manufacturers and importers of all devices:class III devices, and those class II devices that are permanently implantable, life supporting, or life sustaining; and class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must submit malfunction reports in full compliance with FDA's Medical Device Reporting regulation.

• Title 21 Code of Federal Regulations (21CFR) Parts 800 - 1299
• Product Classification Database
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
  Please note: The Medical Device Amendments of May 28, 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.
• Food and Drug Administration Safety and Innovation Act (FDASIA)

  The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health by: 1) Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products; 2) Promoting innovation to speed patient access to safe and effective products; 3) Increasing stakeholder involvement in FDA processes; and 4) Enhancing the safety of the drug supply chain.
• Food and Drug Administration FDASIA Title VI—Medical Device Regulatory Improvements (See pages 59 to 72).
• MAUDE - Manufacturer and User Facility Device Experience

  MAUDE data represents voluntary reports of adverse events involving medical devices.