Identification of Borderline medical devices from medicinal products.

Identification of Borderline Medical devices from Medicinal products_Ethiopian FDA

Identification of Borderline medical devices from medicinal products.

The world of medical products can be complex, especially when it comes to borderline products that blur the lines between medical devices and medicinal products. This ambiguity can pose challenges for manufacturers and healthcare professionals alike. This article aims to shed light on the key principles that differentiate these categories, using the Ethiopian regulatory framework as a reference point.

The Dilemma of Borderline medical products

Imagine a product that promises pain relief. Is it a medicated ointment, or does it utilize some innovative electrical stimulation technology? This exemplifies the borderline product problems. Classifying such products can be tricky, as they seem to possess characteristics of both medical devices and medicinal products. A clear understanding of the distinction is crucial, as regulatory requirements and approval processes differ for each category.

Key Principles for Classification

To confidently navigate the classification process, here are some core principles to consider:

  • Intended Purpose Takes Center Stage: The product’s intended use is paramount. How is it presented, and what is its primary function supposed to achieve? This guiding principle forms the foundation for classification.

Looking at Medical Devices

A product falls under the medical device category if it meets the following criteria:

  • Mode of Action: The principal intended action is achieved primarily through physical means. This could involve mechanical action, functioning as a physical barrier, or supporting or replacing organs or bodily functions.
  • Science Aligns with Claims: There should be a clear alignment between the scientific data regarding the product’s mechanism of action and the manufacturer’s labeling and claims. This strengthens the product’s classification as a medical device.
  • No Pharmacological, Immunological, or Metabolic Influence: The product’s principal function should not be primarily achieved through pharmacological, immunological, or metabolic means. These terms encompass processes that involve interacting with the body at a cellular or molecular level.

A medicinal product’s ancillary in a medical device: A medical device may contain medicinal substances, but their role must be secondary or “ancillary” to the device’s main intended purpose. In simpler terms, the medicinal substance supports the device’s primary function, not the other way around.

Illustrative Examples: Medical Devices

Here are some common examples of products classified as medical devices:

  • Bone cements (without antibiotics) – They primarily function by providing physical support or fixation.
  • Dental filling materials – Their primary action is to restore or repair teeth through physical means.
  • Surgical sutures (absorbable and non-absorbable) – They serve the primary purpose of closing wounds or holding tissues together physically.
  • Bone void fillers (acting primarily as a scaffold) – These products provide a structure for bone growth to occur.

Understanding Accessories of Medical Devices

Accessories are specifically designed to work in conjunction with a particular medical device to ensure it functions as intended. They are not considered medical devices themselves but play a vital role in their safe and effective use. Examples include:

  • Contact lens care solutions (excluding those with therapeutic claims) – These solutions help maintain the cleanliness and functionality of contact lenses.
  • Disinfectants intended for specific medical devices – They ensure proper hygiene and disinfection of medical equipment.
  • Lubricants intended for use with specific medical devices – These lubricants facilitate the use of certain medical devices, such as catheters or endoscopes.

When Devices Deliver Drugs: Drug-Delivery Products as Medical Devices

This category encompasses devices designed specifically to administer medicinal products. The focus here is on the device’s function of delivering the medication, and the overall product falls under medical device regulations. Examples include:

  • Drug delivery pumps – These devices precisely control the delivery of medication into the body.
  • Nebulizers – They convert liquid medication into a mist that can be inhaled.
  • Syringes – They are used for injection or withdrawal of fluids or medications.

As described above, some medical devices incorporate a medicinal substance with an ancillary action. This means that the substance, if used alone, might be considered a medicinal product, but in this context, it supports the device’s primary function. Here are some examples:

  • Catheters coated with antibiotics – The primary purpose of the catheter is drainage, and the antibiotic coating provides additional protection against infection.
  • Bone cements containing antibiotics – Similar to catheters, the cement’s primary function is a physical one- that is to fix bone fractures, and the antibiotic helps prevent infections during surgery.
  • Soft tissue fillers with local anesthetics – The filler provides the structural support, and the anesthetic helps minimize discomfort during injection.

In Conclusion

This article serves as a valuable resource for anyone navigating the borderline medical products that are not clear to distinguish. By understanding the core principles and referring to the provided examples, you’ll be better equipped to classify products accurately. Remember, if doubt persists, seek guidance from the appropriate regulatory body. If you’re still unsure about a product’s classification, don’t hesitate to consult the relevant regulatory authority. They can provide expert guidance based on a case-by-case review, considering all the product’s characteristics.

Please do not hesitate to contact Ethiobiomedical if you have further questions or need additional guidance for registering your products with EFDA.

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