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US and EU Veterinary Medical Device Regulation

Posted 16 April 2018 | By Dr. Viviana MascilongoSharnée Nichols 

US and EU Veterinary Medical Device Regulation

This article describes regulatory efforts applied to veterinary medical devices in the US and EU and explores a small, descriptive sample of veterinary medical devices available on the US market to stimulate growth, innovation and dissemination throughout Europe.

Introduction

The effects of drugs and medical treatment in animals may vary from drug-to-drug and from species-to- species because of physiological and other species differences. In addition, the effectiveness of the drug and use of a veterinary medical device may be expected to vary within a species due to the sex of the animal, or to significant differences in age, weight and size. Too, it may be necessary to provide directions for the medical device's or drug's use in subspecies or varieties of animals in even wider taxonomic groupings for the labeling to be adequate. Generally speaking, both in the US and EU, veterinary medical devices are not as tightly regulated as medical devices designed for human use. In both the US and EU, there is a degree of regulatory oversight, but regulatory efforts and oversight of veterinary medical devices are not globally harmonized and strong data about the use of veterinary medical devices is lacking.

US Veterinary Medical Device Regulation

In the US, veterinary medical devices are available to both veterinary professionals and pet owners. Some devices are designed for use in the clinic, while others are approved for pet owner home use. Both the US and EU regulate veterinary medical devices. The US Federal Food, Drug, and Cosmetic Act (the Act) defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... 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 [which is] intended to affect the structure or any function of the body of man or other animals ... ." Further, a device "does not achieve its primary intended purposes through chemical action within or on the body of man or other animals, and ... is not dependent upon being metabolized for the achievement of its primary intended purposes." Examples of devices include such things as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances.1

Pre-Market Approval is not required and FDA does not require submission of a 510(k), PMA or any pre-market approval for devices used in veterinary medicine. Firms manufacturing radiation-emitting devices must register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).2

Device manufacturers who exclusively manufacture or distribute veterinary devices are not required to register their establishments or to list veterinary devices. They also are exempt from post-marketing reporting.

FDA does provide regulatory oversight for veterinary devices, but the agency can take appropriate regulatory action if a veterinary device has been misbranded or adulterated as it is the responsibility of the manufacturer and/or distributor of these devices to assure they are safe, effective and properly labeled. FDA recommends manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature to ensure compliance with the act. This recommendation also applies to devices marketed in another country or imported into the US.3

The Center for Veterinary Medicine, a branch of FDA, requires species specific labeling for each new animal drug and/or feed containing a new drug to be submitted for approval prior to marketing. Also, medical device labeling may not be false or misleading and devices must be adequately labeled for the intended use(s). However, there are currently no specific regulations covering these requirements.

Animal drug (including medicated animal feed) and veterinary medical device labeling is in violation of Section 502(f) of the act if it fails to identify the target species or provide directions for use adequate for each intended animal classification.4

EU Veterinary Medical Device Regulation

On 26 July 2008, in Europe, the recast of the medical device directive response from Belgium to the public consultation stated, "We remind that veterinary medical devices also need to be regulated at European level."

Veterinary medical devices are not regulated at EU level; the only exception concerns devices to be evaluated if they form part of a medicinal product being evaluated by the European Medicines Agency. For matters of certification and/or placing veterinary medical devices on the market, companies should address the competent national authorities of the member state concerned. Further, it is the responsibility of the production site releasing the batch of finished product to guarantee the quality system for the compliance of these veterinary devices in addition to proper labeling and the product's safety during EU distribution.

Spontaneous trials in veterinary clinics followed by qualified veterinary surgeons can generate data to monitor safety of the veterinary devices and to update the bibliographic references for the promotional literature.

A pragmatic example defines medical devices for veterinary use from a competent national authority of one European member state:

"The Danish legislation and EU directives on medical devices only include medical devices for human beings. Medical devices for veterinary use are not included in the legislation and therefore there is no requirement that they must be CE-marked as medical devices or meet the requirements for CE marking.

Medical devices intended for human beings must be CE-marked and these devices are still covered by the legislation on medical devices when used for veterinarian use.

If the manufacturer becomes aware of a safety related issue with the CE-marked medical device, the Field Safety Corrective Action (FSCA) also must be performed on devices that are provided to veterinary settings."

The Danish Medicines Agency does not issue export certificates for medical devices for veterinary use. If an export certificate is needed, one must contact the Danish Veterinary and Food Administration.5

AVMA Description and Standards: Microchips

The American Veterinary Medical Association (AVMA) has published a technical regulatory description of implantable microchips, cylindrical veterinary devices implanted into subcutaneous tissue using a hypodermic needle. These devices contain four components: a capacitor, antenna, connecting wire and a covering. They are battery-free and sealed in biocompatible glass covered by a sheath to prevent migration. Microchips are activated by a low-power radiofrequency signal emitted by scanners. Electromagnetic induction generates electricity in the antenna and transmits the information stored in the microchip. When activated by the scanner, the microchip transmits a unique, preprogrammed identification number. Some microchips used in animal research also collect and transmit body temperature data.6 The ISO standards 11784/11785 were implemented in 1996. They are accepted by Canada, Europe, Asia and Australia and have been endorsed for use in the US by the American National Standards Institute (ANSI). ISO standard 11784 defines the structure of the microchip information content, and standard 11785 determines the protocol for scanner-microchip communication.7

Veterinary Medical Device Descriptions

In the US, veterinary devices can be purchased online, at veterinary clinics, from medical supply companies or in some cases, directly from the manufacturer.

These products vary greatly in type and purpose.

The following list of 10 veterinary devices is a small representation of the full range of products available to the veterinary community. Each device on this list is accompanied by a description of the product's intended use, technical details, and intended users.

Inflatable E-Collar8
Pet: Dog

Instructions for use:

E-Collars are widely used in veterinary medicine and are useful in preventing licking or chewing most surgical or other wounds. Traditional E-Collars are made of thin plastic sheet material to balance the comfort of the patient and the effectiveness of the E-Collar.

The inflatable E-Collar was designed for the comfort of the patient, yet still effectively offers licking and chewing protection. Pets can move freely about without damaging furniture. They can eat and drink more freely than with traditional collars.

Design Features:

  • heavy duty nylon material covers inner air inflatable vinyl bladder
  • scratch and tear resistant
  • easy to clean and wash
  • easy to use: inflate inner plastic vinyl bladder by mouth until it feels full and close zipper
  • thread pet's collar through the loop inside the inflatable collar
  • place over pet's head and secure the collar plus additional Velcro nylon straps at the bottom outside the inflatable collar

Therapeutic Area: Orthopedics, Dermatology, General Surgery

Used by: Pet Owners, Veterinarians, Veterinary Specialists

Small Animal Shield9
Pet: Cat, Dog

Instructions for use:

Slip this light transparent panel into the cage, push toward the rear, and inject through the evenly spaced holes.

Design Features:

  • easy to clean
  • safe for the handler
  • humane to the animal
  • integral handle for one handed grip

Therapeutic Area: General Practice, General Surgery

Used by: Veterinary Nurses, Veterinarians, Veterinary Specialists

Air Muzzle Pet Restraint10
Pet: Cat, Small Dog

Instructions for use:

Durable, lightweight construction withstands abuse from fractious animals. Unique design restricts view and reduces anxiety of pet. Helps provide unprecedented level of protection for doctor, staff and groomers. Easy to affix to any cat that can be caught by the scruff and animals that can be removed from a pet cage, but are too dangerous to treat without a restraint. Perfect for cats and flat-faced dogs.

Purple vision shield eliminates sight-induced anxiety

Design Features:

  • great for bathing, grooming, administering meds and blood draws
  • ideal tool for jugular venipunctures

Therapeutic Area: General Practice, General Surgery

Used by: Veterinary Nurses, Veterinarians, Veterinary Specialists

Aspir-Guard11
Pet: Cat, Dog

Instructions for use:

Aspir-Guard prevents fluids and dental debris from being accidentally aspirated during a routine dental procedure. Aspir-Guard is a dehydrated PVA donut-shaped product. When rehydrated, it has a soft gentle sponge-like feel. It is placed over the distal end of the ET tube prior to intubation just
outside the epiglottis. Attached strings are used to tie the Aspir-Guard to the roll gauze or old IV tubing used to secure the ET tube to the patient. After the patient is intubated, the Aspir-Guard is pushed into place to block the oropharynx from fluid aspiration. Once the procedure is finished, the Aspir-Guard is removed gently together with the ET tube.

Therapeutic Area: Dentistry

Used by: Veterinary Nurses, Veterinarians, Veterinary Specialists

Dematting Comb12
Pet: Cat, Dog, other small mammals

Instructions for use:

Intended for removing fur mats without shaving. Sharp, serrated blades cut through tough mats quickly. Nylon handle.

Therapeutic Area: General Practice, Dermatology

Used by: Pet Owners, Veterinarians, Veterinary Nurses

Veterinary Tonometer13
Pet: Cat, Dog, other small animals

Instructions for use:

Tono-Pen VET functions in any orientation making it ideal for all of your measurements. The device activates with the push of a button and results are displayed clearly on the easy-to-read LCD screen. All will appreciate the quick and gentle measurement process.

Therapeutic Area: Ophthalmology, General Practice

Used by: Veterinary Nurses, Veterinarians, Veterinary Specialists

Forelimb Prosthetics14
Pet: Dog, Cat

Instructions for use:

Prosthetics are custom made to fit the patient in need. Forelimb prosthetics are used in many cases including subtotal amputation, congenital deformity, and residual limb protection. Some prosthetics include force coupling and a multi-point corrective system. These products are made of various materials to create bi15omechanically appropriate solution for the pet.

Therapeutic Area: Orthopedics

Used by: Pet Owners, Veterinarians, Veterinary Specialists

Non-Skid Shoe Covers15
Pet: All small animals

Instructions for use:

Apply one shoe cover per shoe. These covers provide an effective barrier to protect shoes, sterile environments, or new floor coverings.

Design Features:

  • non-conductive with a non-skid design
  • one size fits all
  • non-sterile, latex-free

Therapeutic Area: All areas

Used by: All veterinary personnel

Lightweight Radiation Protection Apron16
Pet: All small animals

Instructions for use:

Apply appropriate size apron to the front of the body, then secure apron on the back side of the body with attached fasteners. Lightweight aprons are approximately half the weight of lead and provide the protection of 0.5mm lead equivalent. Lightweight aprons are designed to provide veterinary personnel with a lightweight solution available in several sizes to further insure fit, comfort and take the load off your shoulders. Machine washable.

Therapeutic Area: Radiology

Used by: Veterinary Nurses, Veterinarians

Handheld UV Light 17
Pet: All small animals

Instructions for use:

Designed for numerous applications, handheld UV lights are offered in models with magnifiers and white lights to best suit your needs. These lights are used frequently in veterinary medicine to identify and diagnose certain diseases of the skin, including tinea (ringworm).

Therapeutic Area: Dermatology, General Practice

Used by: Veterinary Nurses, Veterinarians, Veterinary Specialists

Conclusion

When considering the variety of approaches for global veterinary medical device regulation, future efforts should strive to support harmonization of technical standards to improve safe and practical utilization. Ease- of-use for these veterinary medical devices in appropriate environments also should be studied carefully, especially with regard to technical, scientific and safety requirements. Future clinical investigation of veterinary medical devices should be encouraged by private sponsorships and spontaneous studies, conducted by veterinary specialists, to provide continuous data to be used as bibliographic sources in preparing the material for scientific divulgation.

References

  1. US FDA Federal Food, Drug, and Cosmetic Act. FDA website. https://www.fda.gov/animalveterinary/resourcesforyou/ucm047117.htm. Accessed 28 March 2018.
  2. About the Center for Devices and Radiological Health. FDA website.  https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm. Accessed 28 March 2018.
  3. Op cit 1.
  4. CPG Sec. 607.100 - Adequate Directions for use (Species Designation) - Animal Drugs and Veterinary Devices. Issued: 10/1/80, Revised: 3/95. FDA website.  https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074652.htm. Accessed 28 March 2018.
  5. Medical Devices Used for Animals. 31 May 2011; Updated 21 January 2015.https://laegemiddelstyrelsen.dk/en/devices/legislation-and-guidance/other-regulation/medical-devices-used-for-animals/. Accessed 28 March 2018.
  6. AVMA Product Information. AVMA website. https://ebusiness.avma.org/ProductCatalog/product.aspx?ID=678. Accessed 28 March 2018.
  7. International Organization for Standardization (ISO) website. https://www.iso.org/standards.html. Accessed 28 March 2018.
  8. Smart Practice website. https://www.smartpractice.com/shop/wa/style?id=SP240106&m=SPV&cid=508928. Accessed 28 March 2018.
  9. Smart Practice website. https://www.smartpractice.com/shop/wa/style?id=SP244284&m=SPV&cid=508928. Accessed 28 March 2018.
  10. Smart Practice website. https://www.smartpractice.com/shop/wa/style?id=S24195&m=SPV&cid=508928. Accessed 28 March 2018.
  11. Jorgensen Labs website. http://www.jorvet.com/product/aspir-guard-set/. Accessed 28 March 2018.
  12. Jorgensen Labs website. http://www.jorvet.com/product/dematting-comb/. Accessed 28 March 2018.
  13. Reichert Technologies website. http://www.reichert.com/product_details.cfm?pcId=432&skuId=3125&skuTk=1065101262#.Wl7MlKinHIU. Accessed 28 March 2018.
  14. Ortho Pets website. https://orthopets.com/brace-and-prosthetic-solutions/thoracic-fore-limb-prosthetics/. Accessed 28 March 2018.
  15. Henry Schein Animal Health website. https://www.henryscheinvet.com/Product?sku=037892. Accessed 28 March 2018.
  16. Henry Schein Animal Health website. https://www.henryscheinvet.com/Product?sku=049665. Accessed 28 March 2018.
  17. Henry Schein Animal Health website. https://www.henryscheinvet.com/Product?sku=000367. Accessed 28 March 2018.    

About the Authors

Dr. Viviana Mascilongo is a regulatory affairs manager and procurator. She has direct contact with EMA, FDA and national drug agencies and ministries of health in EU member countries. She is an EMA Stakeholder: EMA/136736/2016 (17), EMA/739149/2015 (nr. 52). She currently serves as a technical reviewer on the RAPS Editorial Advisory Committee. She can be reached at regulatory@nextraresearch.eu.

Sharnée Nichols, RVT, is an honor graduate of the Bel-Rea Institute of Veterinary Technology. After completing an internship in veterinary oncology, Nichols pursued her veterinary nursing certification to work as a CVT in Colorado, then as an RVT in California. She currently serves an eight-doctor, small animal practice in the San Francisco Bay Area as a Hospital Liaison. She can be reached at sharneenichols@gmail.com.

Cite as: Mascilongo, V. And Nichols, S. "US and EU Veterinary Medical Device Regulation." Regulatory Focus. April 2018. Regulatory Affairs Professionals Society.


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