Medical Device Companies
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)
Typically, we work with our start-up manufacturers in a 4-step process:
- Determine whether 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 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 required.
- Class III Device: typically require 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 FDA to be substantially equivalent.
Product requiring PMAs are Class III devices are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I and II predicate 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 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 application and claims meet the definition of 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 component 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 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.
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 FDA’s Center for Drug Evaluation and Research (CDER).
- Biological products which include blood and blood products, and blood banking equipment are regulated by 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 commecially distribute the device,
- contract sterilizers that commercially distribute the device,
- repackagers and relabelers,
- specification developers,
- reprocessors 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
Our medical device lawyers advise companies on FDA regulatory exposure and how to mitigate the risk of enforcement.
Resources
DRUG AND MEDICAL DEVICE MANUFACTURERS NEED TO COMPLY WITH THE ACA’S SUNSHINE ACT – PART ONE
The Sunshine Rule of the Affordable Care Act requires that drug and medical device manufacturers disclose to CMS any payments they made for the benefit of physicians regarding the drugs or devices.
HEALTH COACHING PLUS: FDA MEDICAL DEVICE AND LEGAL ISSUES
Here’s today’s scenario. Joe is someone who took biology, chemistry, thought about going to medical school, but didn’t do so. Didn’t get a license although he’s got cousins that are nurses and […]
IS YOUR PRODUCT A MEDICAL DEVICE OR GENERAL WELLNESS PRODUCT?
In today’s video, we’ll help you further understand some of the important FDA rules around medical devices.
DIETARY SUPPLEMENTS, COSMETICS, MEDICAL DEVICES – WHY SUBSTANTIATING CLAIMS MATTERS
Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market – why?
FDA EXERTS AUTHORITY OVER MEDICAL DEVICES WITH GENOMICS
FDA flexed its jurisdictional muscle by warning 23andMe that its marketing of the 23andMe saliva test kit and personal genome service without marketing clearance or approval violated that federal […]
ARE EAR CANDLES MEDICAL DEVICES? FDA THINKS SO.
The FDA believes that ear candles are dangerous and should be regulated as medical devices.In Don’t Get Burned: Stay Away From Ear Candles, FDA warns consumers against using ear candles, and […]