FDA Regulatory Requirements for New Medical Devices

The Food and Drug Administration (FDA) requires that medical devices distributed in the United States must first meet the several requirements.  These include facility registration, device listing, device approval, clinical studies, quality systems, labeling requirements and medical device reporting.

1. Facility Registration – Device manufacturers and distributors in the US must register their facility with the FDA.  Most are required to list devices made and activities performed at the facility.

2. Device Listing – Companies are required to list devices with the FDA, including details regarding manufacturers, distributors, re-packagers, re-labelers, re-processors, specification developers, and certain component manufacturers.

3. Device Approval – The approval process depends on FDA device classification.  Any device that does not require Premarket Approval must apply for Premarket Notification, unless exempt.  Device classification is based on perceived risk to the patient/user, and the intended use/indication.

Device Approval Classifications

Class 1 devices are perceived to be the lowest risk devices.  A formal review (i.e., 510(k) or PMA) is not typically required. General Controls are usually sufficient.  Approximately ¾ of all devices listed with the FDA each year are Class 1.  Examples include medical tape and bandages.

Class 2 devices are perceived to be of greater risk to the patient or user.  General controls are not sufficient for safety or efficacy.  Most of these devices require a 510(k) application. Approximately 3,000 Class 2 devices are cleared by the FDA each year.  Most coronary catheters fall within this classification.

Class 3 devices are perceived to represent the highest risk to patient or user.  These devices support or sustain human life, may prevent or impair human health, or present potential risk of illness or injury.  Most Class 3 devices require a PMA application.  Approximately 40 Class 3 devices are approved by the FDA each year.  Examples include heart valves and pacemakers.

Device Approval Process

General Controls are the basic requirements and apply to all medical devices.  These include proper labeling, registration, adverse event reporting and good manufacturing practices. General Controls are the only requirements for most Class 1 devices (i.e., exempt from Premarket Notification).  

Special Controls are applicable to select Class 2 devices that do not require Premarket Notification approval (i.e., exempt), due to perceived lower risk, yet General Controls may be insufficient.  These may include performance, design and manufacturing standards.

Premarket Notification, commonly referred to as 510(k), is a regulatory filing process intended to demonstrate a device is at least as safe and effective as an existing device on the market (i.e., predicate).  Most Class 2 devices require this approval. Bench and animal testing is usually sufficient, but a small percentage requires clinical (human) data.  ‘510(k) Clearance’ refers to a FDA letter that finds the device substantially equivalent and is ‘cleared’ for commercial distribution.

Premarket Approval (PMA) is the most stringent FDA application process that requires scientific evidence to demonstrate a device is safe and effective for intended use.  This applies to most Class 3 devices and requires lab studies and clinical investigations. 

4. Clinical Studies – Devices perceived to represent high risk to patients or users often require clinical studies. This requires an Investigational Device Exemption (IDE) by the FDA to use a device on patients in order to demonstrate safety and efficacy.  This is required for all PMA’s and some 510(k)’s.  Clinical studies for new Class 3 devices usually include pilot trials (<100 patients) and pivotal trials (1,000+ patients at 30-50 sites, over 1-2 years) to define patient populations for safe and effective use of the device. Specified FDA studies can substantially impact the time and cost to commercialize a new device.

5. Quality Systems – These are requirements for methods and controls used in device manufacturing facilities, including purchasing, manufacturing, packaging, labeling, storing, installing and servicing of the devices.  FDA inspects facilities to ensure compliance.

6. Labeling Requirements – These include labels on the devices and descriptive/informative literature about the device.

7. Medical Device Reporting (MDR) – The FDA requires reporting of any incident in which a device may have caused or contributed to an adverse event (e.g., death or injury).  Device malfunctions must also be reported.