Medical Device Legal & Compliance
Guidance
Guidance
Medical device companies face a host of regulatory challenges, including determining whether they are even subject to medical device regulation in the first place (or simply “general wellness” consumer products or non-medical mobile apps), and determining the level of regulatory classification FDA will impose.
We help our clients with FDA issues related to medical devices, including:
Classification of Medical Device (Class I, II or II)
Establishment Registration
Labeling
Medical Device Reporting (MDR)
Premarket Notification (510(k))
Premarket Approval (PMA)
Regulatory Requirements such as Quality System Regulation/Good Manufacturing Practices
513(g) Letter (arguing that product is not a medical device)
Our medical device lawyers advise companies on FDA regulatory exposure and how to mitigate the risk of enforcement.
Typically, we work with our start-up manufacturers in a 4-step process:
- Determine whether the product is in fact regulated as a medical device.
- Determine how the FDA will likely classify the device and whether a 510(k) or PMA is necessary to obtain FDA clearance for marketing, or whether the product is exempt.
- Class I Device: typically exempt (premarket notification and FDA clearance not required before marketing), and in some cases, exempt from GMPs. Registration and Listing are required. Premarket Notification means 510(k), unless exempt, or Premarket Approval (PMA).
- Class II Device (special controls): typically exempt from premarketing notification, but not exempt from GMPs. Registration and Listing are required.
- Class III Device: typically requires Premarket Approval.
- Address:
- Labeling Requirements
- Medical Device Listing on Form FDA-2892
- Medical Device Reporting (MDR)
- Establishment Registration on form FDA-2891
- Quality System (QS) regulation / GMPs
- Develop necessary information to submit a 510(k) or PMA, including labeling.
A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by the FDA to be substantially equivalent. Products requiring PMAs are Class III devices, which are high-risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicates through the 510(k) process. The PMA process is more involved and includes the submission of clinical data to support claims made for the device. The PMA is an actual approval of the device by the FDA. Significantly, the FDA now considers mobile medical apps that function like medical devices to be medical devices and subject to medical device regulation.
Types of Medical Devices
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general-purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation-emitting products with medical applications and claims meet the definition of a medical device. Examples include:
- Diagnostic Ultrasound Products
- Gastroenterological Devices
- Medical Lasers
- Neurological Devices
- X-ray Machines
A product will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and post-marketing regulatory controls if, among other things, it is:
- An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a part, or accessory
- Labeled, promoted, or used in a manner 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 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 its 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.
Medical devices are regulated differently than drugs by the FDA. According to the FDA, if the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Thus:
- Human drugs are regulated by the FDA’s Center for Drug Evaluation and Research (CDER).
- Biological products, which include blood and blood products, and blood banking equipment, are regulated by the FDA’s Center for Biologics Evaluation and Research (CBER).
- FDA’s Center for Veterinary Medicine (CVM) regulates products used with animals.
Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
Among other requirements, manufacturers must list their devices with the FDA.
Establishments required to list their devices include:
- Manufacturers,
- Contract manufacturers that commercially distribute the device,
- Contract sterilizers that commercially distribute the device,
- Repackagers and relabelers,
- Specification developers,
- Reprocessors of single-use devices,
- Remanufacturer
- Manufacturers of accessories and components sold directly to the end user
- U.S. manufacturers of “export only” devices
Medical Device Claims
Evaluating the labeling is an important part of medical device law. Frequently we first analyze the intended use to determine whether a product will even be considered a medical device. Clients call our legal team for legal guidance with respect to:
- Analysis of Marketing Claims
- Importing Requirements
- Investigational Use
- Labeling Requirements
- Adequate Directions for Use
- Labeling for Over-the-Counter (OTC) Devices
- Special Requirements for Specific Devices
- Conditions for Sale
- User Labeling
- Warning Statements