Regulation

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, and products that give off radiation.

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.

 

Overview of Regulatory Requirements – Medical Devices.

FDA approval will be required for the majority of products that may come from members of the Pediatric Device Consortium. The FDA process can be very daunting, but the agency has made every effort to assist small businesses and developers who are looking to get their device approved.

For more information, please visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm

DSMICA

Once you have an idea, the first site to visit at the FDA is The Division of Small Manufacturers, International and Consumer Assistance (DSMICA). The FDA representatives here can provide you with invaluable information on where and how to start your relationship with the agency. 

CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
1 (800) 638-2041
(301) 847-8149 (Fax)
dsmica@fda.hhs.gov

Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4613
Silver Spring, MD 20993

Introduction

One of the most difficult aspects of getting a medical device to market is KNOWING WHERE TO BEGIN i.e., what are the steps for marketing and in what order they are to be taken.

There are a variety of terms that should first be explained.

510(k) Clearance

The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976).  The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions or reject the application.

Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method or performance specifications may also require a new 510(k).

The FDA does not “approve” 510(k) submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.”

Pre-Market Approval or PMA

A primary safeguard in the way FDA regulates medical devices is the requirement that manufacturers must submit to FDA a Premarket Approval (PMA) application if they wish to market any new products that contain new materials or differ in design from products already on the market. A PMA submission must provide valid scientific evidence collected from human clinical trials showing the device is safe and effective for its intended use. If the device you are researching is life sustaining or presents a potential, unreasonable risk of illness or injury, you should search FDA’s Premarket Approval (PMA) releasable database.

PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another. 

For more information, please visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default.htm

Investigational Device Exemption

An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. 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. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

For more information, please visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm

Humanitarian Use Device (HUD)

As defined in 21 CFR 814.3(n), a HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.”  Provisions in the Safe Medical Devices Act of 1990, which became effective on October 24, 1996, allowed for HUDs.  FDA makes its determination that the disease or condition affects or is manifested in fewer than 4,000 individuals in the United States per year after reviewing a request for HUD designation submitted to the Office of Orphan Products Development.

A device manufacturer’s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations

For more information, please visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm

Humanitarian Device Exemption

To obtain approval for an HUD, a humanitarian device exemption (HDE) application is submitted to the FDA. An HDE is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA. An HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition, and that they could not otherwise bring the device to market.
An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is a humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.

We note that the Act, as amended by the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110-85), requires us to establish the annual distribution number (ADN) by assessing projected use of the product in “individuals,” a term that includes both pediatric and adult patients. See section 520(m) (6) (A) (ii) of the Act. This provision authorizes HDE holders to receive profit from the sale of HUDs that are indicated for pediatric use only, or for use in both pediatric and adult patients, subject to the upper limit of the ADN. 

For more information, please visit:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/