FDA Regulations

The US Food and Drug Administration (FDA) is the federal agency responsible for protecting the public from unsafe or ineffective medical products and hospital supplies among other duties. The agency accomplishes its mandate by requiring medical device manufacturers to provide extensive documentation of their medical instruments safety and effectiveness. Manufacturers must comply with certain FDA regulations before they can commercially sell their products in the United States or export them abroad. (Devices that are both manufactured and sold abroad by US companies are not regulated by the FDA.)

FDA Regulations

The FDA is one of the nation’s oldest consumer protection agencies; its predecessor, the Bureau of Chemistry, was established in 1862, and the agency was given its current name in 1930. The FDA today employs about 9,000 people who monitor the manufacture, transport, storage, importation, and sale of foods, drugs, medical devices, cosmetics and radiological products.


In the aggregate, sales from these items amount to more than $1 trillion each year.

The Agency’s Origins
Federal regulation of medical devices began with Congressional enactment of the Federal Food, Drug, and Cosmetic Act of 1938. Among other things, this legislation provided the authority for FDA to prosecute persons engaged in the interstate commerce of adulterated or misbranded medical devices Although this law was an important step forward, it did not require manufacturers to have their products approved by the FDA before beginning commercial sales, as was required for new pharmaceuticals.

This situation changed during the 1970s, when the public became increasingly concerned about the malfunctioning of many newer medical products, such as pacemakers, heart valves, intrauterine contraceptive devices, and other items. Efforts to correct these problems led to the passage of new federal legislation in 1976.

Medical Device Amendments of 1976
This comprehensive watershed legislation established a new regulatory system for medical devices, with the strictness of regulatory controls based on the level of risk associated with a given product. This law established the basic structure for the current scheme used by FDA to regulate medical devices. Among other things, this law requires that most new medical devices undergo a review for safety and effectiveness by FDA before marketing.. An important provision of this statute was the establishment of a three-tier classification system based on the potential risk of a device for the level of regulatory control exercised by FDA. The classifications are as follows:

Class I (General Controls). Medical Devices classified in this category are low risk products that require only “general controls” to assure their safety and effectiveness. Products in class I include products like manual surgical instruments, canes, patient scales, adhesive bandages, and other similar low risk products. Many home health care products also are expected to fit well within the class I criteria. Infection control is another segment that we expect will have significant applications in hospital supplies and many of these products may be classified in class I.

General controls applicable to class I products include the requirements for manufacturers to register their facilities, list the products they manufacture, and comply with FDA’s Quality System Requirements for manufacturing devices (sometimes referred to as good manufacturing practices (GMPs)). There are over 3,000 contract medical devices manufacturers that specialize in meeting the FDA’s requirements for manufacturing medical products.

Most products in class I are exempt from the requirement to submit an application for 510(k) pre-market clearance.

Class II (Special Controls). Medical devices in class II include those products that entail a moderate degree of risk, for which general controls are considered insufficient to ensure safety and effectiveness, but FDA’s “Special Controls” will provide adequate assurance of safety and effectiveness. Examples of such devices are most types of physiological monitors (e.g. ECG monitors), x-ray machines and endoscopes (both of which are used to illuminate and observe body cavities and internal organs and make clinical decisions) and surgical lasers. Special Controls that FDA may use to regulate these products include performance standards, postmarket surveillance, and patient registries.

Most Class II products require submission of a 510(k) premarket notification to FDA at least 90 days prior to introducing the product into commercial distribution.

Class III (Premarket Approval). Comprising sophisticated medical instruments that entail significant risk to the patient, this category includes implantable cardiac pacemakers, angioplasty catheters, and similar devices used to support life or prevent potentially dangerous medical conditions such as heart attacks and cardiac arrhythmias. New products that are not substantially equivalent to a previously marketed devices are automatically classified in class III. Before a Class III product is approved for marketing, its manufacturer must submit to the FDA a Premarket approval application (PMA) which includes documentation of clinical studies demonstrating the product’s safety and effectiveness.

The Safe Medical Device Act of 1990
To further protect the public from approved medical innovations that are later associated with adverse side effects; Congress passed the Safe Medical Device Act of 1990. Among other things, this act amended some of the provisions of the Medical Device Amendments of 1976 and established new FDA rules mandating reporting of device malfunctions.

This act law requires manufacturers, hospitals and other device users to report adverse effects associated with medical devices to the FDA. It also broadened the FDA’s powers to detain or seize products, enjoin future violations, and/or assess civil or criminal penalties, including imposition of fines, for certain violations.

The Safe Medical Device Act of 1990 also created the Humanitarian Device Exemption (HDE), which permits FDA to reduce the extent of clinical data required for approval of products that have been shown to be reasonably safe and present a probable benefit for a US patient population of fewer than 4,000.

The FDA Modernization Act of 1997
Following years of industry pressure to streamline the FDA’s regulatory system for medical inventions, Congress passed legislation in the fall of 1997 designed to make the new device approval process more efficient. The bill exempted most low-risk Class I medical devices from some requirements (such as 510(k)) and allowed outside third-party experts to review certain premarket notifications for Class II medium-risk devices. One purpose of these changes was to free up valuable FDA review time so that it could be devoted to high-risk Class III medical equipment.

The Medical Device User Fee and Modernization Act of 2002
Signed into law in October 2002, this legislation amended the Federal Food, Drug, and Cosmetic Act, providing the FDA with new responsibilities, resources, and challenges. The act has three particularly significant provisions:

Fees. The act established user fees for the review of medical device premarket submissions.

Inspections. Accredited third parties under carefully prescribed conditions will conduct manufacturing facilities inspections and audits.

New rules for reprocessed devices. The act created new regulatory requirements for reprocessed single-use devices, including a new category of premarket submissions to be known as the premarket report. These medical instruments are defined as those originally intended for one use, or for a single patient during a single procedure, which have been previously used and subsequently reprocessed.

The Road to Approval
Medical device manufacturers seeking approval from the FDA to market their products must submit detailed documentation substantiating the medical devices’ safety and effectiveness. Three of the most common filings are as follows:

510(k) Premarket Notification. Medical devices that are substantially similar to products already on the market can usually obtain FDA clearance via the agency’s premarket notification process, known as a 510(k).. This review process is required for a few class I devices, most Class II devices and some Class III devices.

In a 510(k) filing, the FDA requires that medical device manufacturers provide information and data (which may include clinical data) demonstrating that the new device is substantially equivalent to previously marketed devices and does not raise any new questions with respect to safety or efficacy. If a manufacturer proposes several different medical uses for a device, the agency may require the submission of different 510(k) applications with data establishing the substantial equivalence for each application. Generally a 510(k) filing is reviewed and cleared by FDA in less than 3 months if the preparation work is well done.

Premarket application (PMA). For Class III medical devices and devices that employ novel methods of treatment and are not substantially equivalent to currently marketed medical devices, manufacturers must submit a Premarket Approval Application to the FDA.

A PMA is much more complex and time-consuming to prepare than a 510(k). A PMA submission typically contains a significant quantity of clinical, animal testing, manufacturing, and other data, all of which the FDA carefully scrutinizes.

After a PMA is submitted, the FDA usually assembles a scientific advisory panel to study the PMA application. The panel, comprising physicians and other experts in fields relevant to the submission, may hold a public meeting during which the PMA application is reviewed and discussed. After evaluating the data in the PMA, the panel will recommend to FDA that it be approved, approved with conditions, or not approved. Although the FDA is not bound to follow the panel’s recommendations, it tends to give them considerable weight.

Investigational device exemption (IDE). The IDE applies to any device that has not been cleared or approved by FDA for marketing which is to be evaluated in a clinical trial. The approval process for a new Class III device typically begins when the manufacturer submits an investigational device exemption to the FDA. If granted, this exemption lets the manufacturer conduct human clinical trials using the device. Typically an initial clinical study of a new product will involve fewer than 100 people. Based on the results of these initial studies, the FDA may let the manufacturer test the product on larger patient populations.

The results of the clinical studies performed under the IDE may be used to support a 510(k) submission or a PMA application. If the clinical data are submitted to support a PMA, an FDA advisory panel of outside experts will usually be asked by FDA to evaluate the clinical results. Assuming the panel is satisfied with the results, the FDA may grant premarket approval, subject to the satisfaction of its other requirements. The entire process, from IDE to PMA approval could take from three to six years.

A device may be marketed to the medical community or the public upon receiving premarket approval or final FDA marketing approval.

During its fiscal year ended September 30, 2003 (latest available), the FDA received 54 PMAs. Of these, 31 were approved, 16 were found approvable, and 10 were not approved.. The average total time from first submission to FDA decision was 359 days.

Eureka’s Target Products
Eureka is targeting innovative medical products that require 510 (k) premarket notifications because of their relative ease in getting quickly to market. These generally require less than six months to achieve FDA clearance and can be effective in solving many of the pressing issues in healthcare such as preventable medical errors and infection control. We also believe that medical technologies that satisfy the growing trend for home health care products that require only a 510(k) offer a significant opportunity.

Medical devices that require PMAs represent less than 25% of our product portfolio and must have significant markets to justify the clinical and regulatory expense. Innovative medical devices and diagnostic products that require a PMA are targeted for licensing with our major sponsors or venture partners who do most of the work on clinical evaluation and FDA approval process. If the product meets our criteria we can get it to the next level.

MDCI (link www.mdci.com ) is a leading global FDA registration and insurance reimbursement consultant who participates regularly in Eureka Medical’s expert medical panel at our Medical Invention Roadshows. MDCI also serves on Eureka’s Advisory Board.

FDA Medical Inventions: MDCI.