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From Bench to Bedside: Five Steps to Obtaining FDA Clearance for your Medical Device

Process Overviewuntitled

The journey from product ideation and discovery to clinically utilized patient care device can be a daunting one. There are five important steps to marketing a new medical device with FDA clearance. We will attempt to streamline this process and make it more user friendly. It is crucial to be familiar with the governmental regulations at play here.

Is the product a medical device?

While this may sound like a simplistic question, it is important to make sure that your product meets the qualifications to be considered a medical device before embarking on the process of obtaining FDA clearance. A medical device is defined within the Food Drug & Cosmetic Act as

“…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” [1]

Regulatory Controls

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. It is important to note that not all medical devices are created equal in the eyes of the government. Some will be subject to further regulations depending on how they are classified (ones that emit radiation for instance). Which brings us to our first step in bringing your device to market, finding the appropriate classification.

Device Classification

untitledStep I: Classify the Device

Under the Federal Food, Drug, and Cosmetic Act, all medical devices must be classified under one of three categories:

  1. Class I devices: This is the “low to moderate risk” category. These devices present a low risk of harm to the individual user and will fall under general regulatory controls. Many of these devices may even be exempt from parts of the regulatory process. Some examples of class I devices are bandages, compression stockings, manual blood pressure cuffs, and stethoscopes. These are non-invasive devices that don’t require special patient precautions prior to usage.
  2. Class II devices: This category is considered “moderate to high risk”. These devices are usually non-invasive but slightly more complicated in their usage and present a moderate risk to the patient.   Therefore, devices in this category must be subject to the special controls in addition to general governmental controls. Such devices require further monitoring and must meet performance standards for the patients. In addition, a Premarket Notification 501(k) must be filed for these products. A few examples include x-ray machines, infusion pumps, and electronic wheelchairs.
  3. Class III devices: This is considered the “high risk” category. Devices within this category are invasive, present a potential significant risk to the patient, or fill a highly important role in supporting the life of the patient. Therefore, they are subject to the strictest controls to ensure their safety and efficacy. They are often subject to premarket approval (PMA). Such devices include implantable defibrillators, pacemakers, artificial heart valves, and breast implants. [2]

Step II: Premarket submission

Depending on the device classification, a premarket submission may be required prior to marketing the new device. A few common types of premarket submissions are:

  1. Premarket Approval (PMA): This type of submission is the most rigorous type of application required by the FDA. This approval is required for many class III devices and is only granted when the FDA review finds sufficient scientific evidence that the device is both safe and effective. This type of approval generally requires randomized clinical trials or meta-analysis to establish a greater benefit vs. potential risk of use.
  2. Premarket Notification 510(k): in contrast to the FDA “approval” granted through the PMA process, a 510(k) is designed to obtain FDA “clearance” by proving that the device is substantially equivalent to a predicate device currently on the market.
  3. Humanitarian Device Exemption: This exemption is intended to provide incentive to companies who produce products that aid in the treatment of diseases that affect only a small portion of the population.
  4. Investigational Device Exemption: This allows a new device to be used in clinical studies.

Step III: Determine what kind of studies are needed to support your device

The requirements of your submission packet will entirely depend on which premarket submission category your device falls into. If your goal is to market a Class III device, you will likely be required to follow the PMA process of scientific and regulatory review. The FDA has established elevated general and special controls in order to appropriately evaluate a device that will be depended on to support or sustain human life, and which will carry a substantial risk of illness or injury. Companies who want to market a Class I, II, or III device that does not fall under PMA requirements, must then submit a 510(k).

Step IV: Submit your completed packet and interact with FDA during the review process

Once you have gathered the appropriate supportive information for your device, the completed packet can be submitted to the FDA along with any required fees. The submission packet will then undergo an administrative filing review during which FDA representatives will assess the submission for completeness. This evaluation is then followed by an interactive review, which requires close communication between FDA staff and the applicant.

Step V: Complete your registration and device listing with the FDA

The final step before commercial marketing is establishment registration and device listing. Any company that develops and markets medical devices must register annually with the FDA. Once a device is approved, it must be added to the FDA list of medical devices. These ultimate steps serve several purposes. They allow the FDA to monitor performance and usage of medical devices. More importantly, knowing where devices are developed can be vital information during national public health emergencies.

Final Thoughts…

Though the road from device development to FDA approval and commercial release may be complicated at times, it is important to be sure to follow FDA regulations precisely. Processing time can be minimized through close communication with FDA staff, and usage of the wealth of regulatory information presented on their website.

Helpful Links

FDA’s Center for Devices and Radiological Health (CDRH) web page: http://www.fda.gov/Training/CDRHLearn/ucm126230.htm

Types of Communication During the Review of Medical Device Submissions – Guidance for Industry and Food and Drug Administration Staff http://www.fda.gov/Training/CDRHLearn/ucm126230.htm

References

  1. FDA Overview of Medical Device Regulation. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm
  2. FDA Resource Guide, Learn if a Medical Device Has Been Cleared by FDA for Marketing http://www.fda.gov/MedicalDevices/ ResourcesforYou/Consumers/ucm142523.htm