Hope for HIE – Hypoxic Ischemic Encephalopathy Hope for HIE – Hypoxic Ischemic Encephalopathy


Decoding FDA Designations in Health Information

November 10th, 2023  | Advocacy  | News


In the complex world of healthcare, understanding FDA classifications is crucial for making informed decisions. The United States Food and Drug Administration (FDA) plays a vital role in ensuring the safety and effectiveness of medical products, but the distinctions between FDA approval, FDA clearance, FDA authorization, and FDA de novo, along with the impact of marketing language, can be challenging. In this post, we’ll explore each FDA classification to empower you with the knowledge needed to navigate the healthcare landscape.

Worldwide, many countries rely on the consistency of how the FDA rules on certain medications, therapeutics, devices and more to guide their processes in their own regulatory approvals for consumers to have access to certain medications, devices, and more.

FDA Approval: The Gold Standard

When a medical product receives FDA approval, it’s a significant validation. This means it has undergone thorough clinical trials to ensure both safety and effectiveness. FDA approval is typically reserved for new drugs, biologics, and high-risk medical devices, making it the highest level of endorsement.

FDA Cleared: Gatekeeping for Lower-Risk Devices

Contrasting with the detailed FDA approval process, FDA clearance is for lower-risk medical devices. Clearance requires demonstrating substantial equivalence to an already legally marketed device. While notable, FDA clearance doesn’t undergo the same level of scrutiny as FDA approval.

The FDA clearance process for medical devices involves different levels of scrutiny, and the distinctions help ensure the safety and effectiveness of these devices. Here are the primary levels of FDA clearance:

  1. Class I Devices: General Controls
    • Description: Class I devices are low-risk and generally pose minimal potential harm to users. They include devices such as bandages, dental floss, and basic diagnostic equipment. Most Class I devices are subject to general controls, which are basic requirements for manufacturing, labeling, and record-keeping to ensure their safety and efficacy.
    • Clearance Process: Many Class I devices are exempt from the need for FDA clearance, but some may still require registration with the FDA to ensure they comply with general controls.
  2. Class II Devices: Special Controls
    • Description: Class II devices are moderate-risk and require more regulatory controls than Class I devices. Examples include powered wheelchairs, infusion pumps, and some diagnostic devices. Special controls may include performance standards, post-market surveillance, patient registries, and guidelines to mitigate identified risks.
    • Clearance Process: Most Class II devices go through the 510(k) premarket notification process. Manufacturers must demonstrate that their device is substantially equivalent to an existing, legally marketed device (predicate device) and complies with applicable special controls.
  3. Class III Devices: Premarket Approval (PMA)
    • Description: Class III devices are high-risk and may be life-supporting or life-sustaining. Examples include implantable cardiac pacemakers, heart valves, and certain diagnostic imaging devices. Due to their elevated risk, Class III devices undergo the most rigorous level of regulatory control.
    • Clearance Process: Class III devices typically require a Premarket Approval (PMA), which involves submitting comprehensive scientific evidence, including clinical trial data, to demonstrate the device’s safety and effectiveness. PMA is the most stringent pathway and is necessary to ensure the highest level of scrutiny before the device can be marketed.

Understanding these different levels of FDA clearance is crucial for manufacturers and healthcare professionals, as well as for consumers who want to make informed choices about the medical devices they use. The classification system helps strike a balance between facilitating innovation and ensuring the safety and effectiveness of medical devices in the market.

For HIE families, many different devices are marketed that may be FDA cleared, but not FDA approved. This matters in how they are used, and your knowledge of how the safety and effectiveness is not to the highest standard.

FDA Authorization: Swift Response to Emergencies

FDA authorization comes into play during public health emergencies, allowing the rapid distribution of medical products like vaccines and treatments. This expedited pathway enables a timely response without compromising safety. However, it’s important to note that ongoing monitoring and further studies continue post-authorization.

FDA De Novo: Pioneering New Technologies

The FDA de novo pathway accommodates novel (new and unique), low to moderate-risk medical devices without a legally marketed counterpart. This pathway allows for the classification of innovative technologies through a comprehensive evaluation process to ensure both novelty and safety reach the market.

FDA Listed Products: Meeting Basic Standards

Description: FDA listing involves registering a medical device establishment with the FDA. This registration process is not a clearance or approval but is rather a basic requirement for manufacturers, distributors, and importers of medical devices. It establishes a connection between the company and its products, indicating compliance with FDA regulations.

Significance for Consumers:

  • Adherence to Basic Standards: When a product is FDA listed, it means the manufacturer or distributor has complied with the FDA’s basic standards for device manufacturing, labeling, and record-keeping. This includes meeting requirements related to quality systems and good manufacturing practices (QSR/GMP).
  • Traceability: FDA listing provides traceability, enabling the FDA to monitor and communicate with establishments in case of recalls, safety alerts, or other regulatory matters.
  • Consumer Awareness: While FDA listing doesn’t imply a specific level of safety or effectiveness, it does contribute to transparency. Consumers can verify whether a medical device or its manufacturer is listed on the FDA’s public database, fostering awareness and trust.

FDA Registered Products: A Step Beyond Basic Compliance

Description: FDA registration is a voluntary process for establishments involved in the production, distribution, and importation of medical devices. While registration doesn’t imply clearance or approval, it represents a proactive step by the manufacturer or distributor to engage with the FDA. It involves providing information about the company and the devices it handles.

Significance for Consumers:

  • Enhanced Transparency: When a product or its manufacturer is FDA registered, it indicates a commitment to transparency and a willingness to comply with regulatory requirements. This extra step in the registration process reflects a proactive approach to engage with the FDA.
  • Faster Response to Emergencies: In times of public health emergencies, FDA registration facilitates a quicker response. Registered establishments are more readily accessible to the FDA for communication regarding recalls, safety alerts, or other urgent matters, contributing to public safety.
  • Global Market Access: FDA registration is often a prerequisite for exporting medical devices to international markets. This global recognition can signify adherence to international quality and safety standards, which can be reassuring for consumers.

Marketing Jargon: Understanding the Message

Consumers need to be cautious when interpreting marketing language. Terms like “FDA compliant” or “FDA registered” may sound reassuring, but they don’t guarantee the thorough evaluations associated with FDA approval. While these terms indicate adherence to certain standards or listing with the FDA, they don’t match the level of scrutiny that comes with FDA approval.

In addition, some companies use terms that are not accurate to overhype or oversell the capabilities, safety and effectiveness of their products.




Connect with families, read inspiring stories, and get helpful resources delivered right to your inbox.

  • This field is for validation purposes and should be left unchanged.