Why Medical Device Companies Need to Fear FDA Warning Letters

The FDA will conduct its examination into possible FDA violations of medical devices by making an on-site inspection, reviewing the marketing materials and company website, examining current good manufacturing practices, and taking other steps.

As with most warning letters, the best defense is to be proactive. Speak with an experienced FDA medical device lawyer who understands the relevant laws and can help you address and set up procedures to minimize the risk of being charged with violating the relevant laws. Skilled FDA medical device lawyers also help clients prepare appropriate responses to FDA warning letters so that the warnings don’t escalate into the need to stop production, civil and criminal fines.

When the FDA does issue a warning letter, there is normally little time, generally a few weeks, before more serious action will be taken. The FDA may impose fines, seek an order to cease production. They may even file a criminal complaint.


If you think medical device advertising is immune from criminal prosecution, look to the current charges against the CEO of Vascular Solutions.

Medical device definition

Medical devices include items such as bedpans and tongue depressors. More and more medical devices include items with complex technology – such as pacemakers that have microchips, and laser surgical devices. Other medical devices include “vitro diagnostic products such as general-purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology.

Some products the emit radiation may qualify as a medical device.  Some of the items in this category include X-ray machines, ultrasound devices, and medical lasers.

The Food, Drug, & Cosmetic Act defines a medical device as follows:

“an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including a component part, or accessory 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 its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve 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 its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).”

Products which focus on chemical actions are usually classified as drugs.

Today, many apps may qualify as medical devices.


Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.


Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA’s view, diagnoses and treats disease.

Medical device regulation

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III.

  • Most Class I devices are exempt from Premarket Notification 510(k)
  • Most Class II devices require Premarket Notification 510(k)
  • Most Class III devices require Premarket Approval.” Class III devices generally pose a severe risk of injury or illness.

If your device requires the submission of a Premarket Notification 510(k), you cannot commercially distribute the device until you receive a letter of substantial equivalence from FDA authorizing you to do so. 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.


If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? […]

Medical devices are also subject to Quality System Regulation. Quality system regulation includes examining the controls and methods for:

  • Manufacturing medical devices
  • Packaging and labeling the devices
  • Storing, installing and servicing medical devices

Experienced FDA medical device lawyers can explain if your product will be classified as a medical device and what classification (I, II, or III) will be applied to the medical device.

There are numerous controls of medical devices that are set forth in the Food, Drug, and Cosmetic Act. Some of the leading controls that the FDA will review are:

  • 501: Adulteration
  • 502: Misbranding
  • 510: Registration of producers of devices
  • 516: Banned devices
  • 518: Notifications and other remedies
  • 519: Records and reports on devices
  • 520: General provisions respecting control of devices intended for human use


Medical devices are considered adulterated for many reasons including:

  • It includes any filthy, putrid, or decomposed substance,
  • It is prepared, packed, or held under unsanitary conditions.
  • Its container is composed, in whole or part, of any poisonous or deleterious substance;
  • It contains, for the purposes of coloring only, an unsafe color additive; and
  • Its strength differs from, or its purity or quality falls below, that which it claims to represent.
  • It is in violation of good manufacturing practice requirements.


Many of the misbranding provisions apply to both medical devices and drugs. Some types of misbranding common to medical devices and drugs includes:

  • False and misleading labeling
  • The packaging doesn’t have a label with complete information
  • Required information is lacking
  • The label doesn’t have adequate directions for use

Misbranding provisions that just apply to medical devices include:

  • The name of the device isn’t prominently displayed
  • The device violates restricted devices regulations
  • The device is commercially distributed without FDA concurrence on a Section 510(k) submission.
  • The device is subject to a performance standard and it does not bear the labeling prescribed in that standard.

A skilled FDA medical device lawyer can explain all the provisions that apply to medical devices.

FDA Warning letter to a sterilizer manufacturer, 10/6/2018

The FDA wrote that it had inspected the company’s plant for several weeks. Two of the medical devices the company manufactured were “contract sterilizers of various surgical trays” and hospital kits. The letter designated these products as devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The violations that were discovered included:

  • Adulteration of the medical devices – because the manufacturing, packing, storage, and installation methods did not conform to current good manufacturing practices (CGMP). The specific CGMP violations included:
    • “we observed that your sterilization operations have not been adequately validated to demonstrate that all component materials, sizes, solutions, types, etc., can undergo and withstand your sterilization process.
    • Failures regarding the packing process
    • “Your firm does not have any procedures for the monitoring and control of critical process parameters such as: bag vacuum level; plastic bag serial number; plastic bag size; seal wattage; evaporation temperature; or during routine sterilization operations.
    • “Failure to develop, conduct, control and monitor production processes to ensure that a device conforms to its specifications.”
    • “Your firm has not provided an adequate structure of resources, including the assignment of a dedicated individual that is responsible for overseeing the day-to day quality operations at this location.”

The FDA noted that the company had prepared a response but that the timeline for corrective actions proposed in the response was not acceptable. Specifically, the FDA said that they needed to have supporting data to support the company’s sterility claim.

The FDA letter warned the company that if they failed to take prompt corrective action within 15 days from the date of the letter, they could face:

  • Product seizure
  • An injunction
  • Civil money damages
  • Notification of the issuance of the FDA warning letters to other federal agencies
  • Denial of premarket approval application of the medical devices
  • Denial of requests for Certificates to Foreign Governments

FDA Warning letter to a Medical Device manufacturer, 9/14/18

The FDA issued a warning letter based on an on-site inspection. The FDA warning letter is instructive because it is an example of an effective response. The FDA did acknowledge that many of the corrective measures identified were adequate – but that an onsite inspection would be required.

The medical devices manufactured included:

  • The pre-filled Heparin lock flush syringe
  • The pre-filled 0.9% sodium chloride lock flush syringe

The Food, Drug, and Cosmetic Act regulates these items as medical devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The FDA inspection revealed that the products were adulterated because the manufacturing, packing, storing, and installation methods were not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. www.fda.gov.

The FDA found the following nonconforming CGMPs:

  • Failed to adequately establish procedures to control environmental conditions, such as using municipal tap water which has been found to be a potential source of microbial contamination through FDA sampling. The FDA asserted that the medical device company didn’t routinely inspect the municipal tap water for “microbial load to ensure dilutions are effective for cleaning and sanitation. The FDA did find samples of contamination in the samples taken.

The FDA did find that the corrective actions such as discontinuing tap water usages and using sterile disinfectants, temporarily shutting down manufacturing operations, removing the tainted faucets, and establishing a revised cleaning program were adequate – but that a follow-up FDA inspection would be required.

  • Failure to adequately establish procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality. As a result of these failures, the FDA noted that numerous types of bacteria were isolated in environmental swab samples that the FDA collected.

The FDA did acknowledge that the medical device company identified corrective measures including discontinued use of non-sterile spray bottles used to hold cleaning and disinfecting solutions and the company’s commitment to:

    • implement procedural revisions to include the use of only sterile spray bottles to hold cleaning and disinfecting solutions;
    • validate the cleaning process;
    • revise procedures and perform employee retraining for proper cleaning behavior and practices; and
    • the evaluation of the environmental monitoring program.

Several other CGMP/adulteration failures were noted. Again, the FDA found the reply adequate subject to a follow-up investigation.

Less recent FDA warning letters address other violations such as misbranding.

Experienced FDA medical devices understand the Food, Drug, and Cosmetic Act. This includes when items qualify as medical devices, what notifications and approvals are required, and what provisions of the act must be met. In most cases, an effective review of a medical device company’s procedures, packaging, labeling, and marketing can help determine where flaws exist. With proper legal review, these flaws can address before the FDA conducts in examination. When the FDA does issue warning letters, experienced FDA medical device compliance lawyers can quickly work to draft replies that will expedite the FDA’s approval of your products.

Contact the FDA medical device warning letter lawyers at Cohen Healthcare Law Group, PC today. We can help your company take proactive steps to reduce the risk of FDA warning letters and help your company make, market, and sell approved medical devices.

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