FDA Regulations for Medical Device Approval in USA

FDA’s Center for Devices and Radiological Health (CDRH) oversees the regulation of companies that manufacture, repackage, re-label, or import medical devices sold within the U.S. CDRH also regulates radiation‑emitting electronic products, both medical and non-medical, including lasers, x‑ray systems, ultrasound devices, microwave ovens, and color televisions.

Medical devices fall into three categories—Class I, II, and III—based on the level of regulatory control required to ensure safety and effectiveness. Class I devices are subject to the least regulatory oversight, while Class III devices require the most stringent controls. Most Class I devices are exempt from Premarket Notification 510(k), most Class II devices require a 510(k), and most Class III devices require Premarket Approval (PMA).

Manufacturers distributing medical devices in the U.S. must comply with the following primary regulatory requirements:

• Establishment Registration 
• Medical Device Listing 
• Premarket Notification 510(k) (unless exempt) or Premarket Approval (PMA) 
• Investigational Device Exemption (IDE) for clinical studies 
• Quality System (QS) Regulation 
• Labeling requirements 
• Medical Device Reporting (MDR)

Establishment Registration – 21 CFR Part 807

Domestic and foreign manufacturers, as well as initial importers, must register their establishments with the FDA. Registration is submitted electronically unless the FDA grants a waiver. All establishments must verify their registration annually between October 1 and December 31. Foreign manufacturers are also required to appoint a U.S. Agent. Since October 1, 2007, most establishments must pay a registration fee.

Medical Device Listing – 21 CFR Part 807

Manufacturers are required to list their devices with the FDA. Entities that must complete device listing include:

• Manufacturers 
• Contract manufacturers 
• Contract sterilizers 
• Re‑packagers and re‑labelers 
• Specification developers 
• Re‑processors of single‑use devices 
• Remanufacturers 
• Manufacturers of accessories and components sold directly to end users 
• U.S. manufacturers of “export only” devices

Premarket Notification 510(k) – 21 CFR Part 807 Subpart E

Devices requiring a Premarket Notification 510(k) cannot be marketed until the FDA issues a letter confirming substantial equivalence. A 510(k) must demonstrate that the device is substantially equivalent to one legally marketed in the U.S. before May 28, 1976, or to another device previously deemed substantially equivalent.

The Medical Device User Fee and Modernization Act of 2002 authorizes the FDA to charge fees for 510(k) submissions, with reduced fees available for small businesses. Traditional, Abbreviated, and Special 510(k)s are subject to these fees. Many Class I and select Class II devices are exempt from the 510(k) requirement.

Manufacturers may opt for review by an Accredited Person for certain Class I and Class II devices. FDA-accredited organizations can conduct reviews for over 670 device types. The FDA must issue a final determination within 30 days of receiving the Accredited Person’s recommendation. While FDA fees do not apply to these reviews, the accredited organization may charge its own fees.

Premarket Approval (PMA) – 21 CFR Part 814

Class III devices, considered high-risk and capable of causing serious injury or illness, generally require PMA. Devices found not substantially equivalent through the 510(k) process also fall under PMA requirements. PMA submissions are more rigorous and typically include clinical data supporting the device’s safety and effectiveness.

User fees apply to original PMAs and certain supplements. Small businesses may qualify for reduced or waived fees.

Investigational Device Exemption (IDE) – 21 CFR Part 812

An IDE permits the use of an investigational device in clinical studies to collect data required for PMA or 510(k) submissions. Studies involving significant‑risk devices require approval from both the FDA and an Institutional Review Board (IRB). Studies involving non‑significant‑risk devices require only IRB approval.

Quality System Regulation (QS Regulation) – 21 CFR Part 820

The QS regulation outlines requirements for methods, facilities, and controls used in designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices. FDA inspections ensure compliance with these quality system requirements.

Medical Device Reporting (MDR) – 21 CFR Part 803

Manufacturers must report incidents in which a device may have caused or contributed to a death or serious injury. Certain device malfunctions must also be reported. The MDR system enables the FDA and manufacturers to identify, investigate, and correct significant device‑related issues promptly.ufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner.