What is the NDC?

The NDC is an FDA standard for uniquely identifying drugs marketed in the U.S. Currently, the NDC assigned by the FDA for each listed drug marketed in the U.S. is a unique 10-digit number and can be in several different formats.

Current formats:

10-digit identifier

The FDA’s standard NDC is a 10-digit numerical identifier that includes a labeler code, product code, and package code.

There are 3 FDA-assigned formats for the standard NDC:

• 4-4-2
• 5-3-2
• 5-4-1

HIPAA Format

The Health Insurance Portability and Accountability Act (HIPAA) adopted a uniform 11-digit NDC format that must be used when a HIPAA-covered transaction includes an NDC. This 11-digit format is standardized into a 5-4-2 format and created by adding a leading zero to either the labeler, product, or package code.

Upcoming 6-Digit Format

The FDA will run out of 5-digit labeler codes in 10-15 years. Per FDA regulations (21 CFR 207.33), once the FDA runs out of 5-digit labeler codes, it will start assigning 6-digit labeler codes. Without this proposed change, there would be five NDC formats, 3 in 10- digits and 2 in 11-digits. There may be confusion between an FDA-assigned 11-digit NDC and a HIPAA converted 11-digit NDC.

The New NDC Standard

The Final Rule modifies existing regulations to establish a uniform, 12-digit format that can accommodate longer NDCs once the FDA begins issuing 6-digit labeler codes.

The change will impact a variety of industries and stakeholders, including:

• Human and animal drug manufacturers and distributors
• Drug importers
• Federal agencies using the NDC
• Drug databanks
• Pharmacies
• Hospitals, clinics, labs, healthcare practitioners
• Nursing care facilities
• Electronic health record vendors
• State and local governments
• Various supply chain stakeholders

The rule change standardizes the NDC format across all sectors and minimizes confusion and medication errors.

During the seven years before the rule takes effect (March 5, 2026 – March 6, 2033), the FDA will continue to assign 10-digit NDCs in the current formats. Manufacturers, distributors, repackagers, relabelers, pharmacies, health care providers, payors, and other supply chain partners should use this time to update their systems, processes, and infrastructure to handle the 12-digit NDC format by March 7, 2033.

Diaz Trade Law will continue to monitor developments concerning this proposed rule. We provide guidance on a variety of FDA matters, including food, cosmetics, drugs, alcohol, medical devices, and more.

Learn more about FDA compliance:

• Webinar: Tips on FDA’s Medical Device Registration Process
• FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations
• Webinar: Importing Medical Devices in Compliance with U.S. FDA
• Webinar: FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Detentions, Warning Letters, and Import Alerts: How to Use FDA’s Databases to Perform Due Diligence
• Webinar: Getting MoCRA Compliant

• Coordinated National Response: Rather than each port conducting manual reviews of certain entries on its own, specialized teams now coordinate their efforts across the country to more quickly identify and stop dangerous products.

• Harmonized Real-Time Alert System: If the FDA detects a high-risk product at one port, such as contaminated infant formula or counterfeit drugs, alerts are immediately shared across all ports so they can watch for the same threats.

• Improved Efficiency: Built on a successful 2022 pilot, the NER program has sped up processing by 70% and increased detection of high-risk products by 36%.

• Expanded Reviewer Capacity: The program allows for more FDA reviewer availability and collaboration across the national network. 

The FDA’s current evaluative standards, regulatory requirements, and admissibility thresholds remain the same. 

The FDA has also published a communications guide that includes general contact protocols, hot shipments handling, email formatting requirements, and FAQs.

Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions. For assistance with NER requirements or other FDA matters, contact us at 305-456-3830 or info@diaztradelaw.com.

Learn more:

• A New Era in Cosmetics Regulation: The Modernization of Cosmetic Regulations Act
• FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions
• Webinar: Getting MoCRA Compliant
• FDA Issues New Rules on Use of the Term “Healthy” on Food Labeling
• FDA Issues Proposed Rule on Front-of-Package Nutrition Labeling

What we learned

Both medical device transition plans follow a similar structure, with some minor differences, in what is asked for from the trade community. Under the issued medical device transition plans, the entire plan follows a 180-day cycle in which by day 90 notifications of intent must be submitted to the FDA and by day 180, marketing submissions must be submitted and accepted by FDA. Please see below for a more thorough breakdown of each of the transition plans.

Devices Issued Emergency Use Authorizations (EUA)

Day 0: Advance notice of termination in Federal Register – EUAs are still active for the full 180-day transition time period

By Day 90:

• FDA recommends that manufacturers of certain life-supporting or life-sustaining devices submit to FDA a “letter of intent”, with information regarding their intention to submit a marketing submission to continue the distribution of their product. or their intention to cease distribution of their product and how they intend on doing so.  The draft guidance recommends that manufacturers of such devices include in this notification:
  • General information (e.g., contact information).
  • The EUA request number.
  • A list of all model numbers or other device identifying information.
  • Whether the manufacturer plans to submit a marketing submission.
  • If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plan to stop distribution of the device, to restore the device to a previously FDA-cleared or approved version, to provide a physical copy or electronic updated labeling, and any other efforts to address or mitigate potential risks of devices that remain distributed after the EUA termination date.
• The manufacturer should submit this information designated with the EUA number as an “EUA report.” FDA recommends that manufacturers notate the following on the cover letter of the submission: “Attention: Notification of Intent.”

By Day 180:

• Manufacturers should have a marketing submission submitted and accepted by the FDA meaning FDA has confirmed receipt of the marketing submission.  You are allowed to continue the importation and distribution of your device until the FDA issues a final action on your marketing submission.
• According to the draft guidance, marketing submissions should be considered “transition implementation plan that addresses the manufacturers’ plans for devices already distributed in the case of a positive decision or a negative decision on its marketing submission”. This marketing submission should include the following:
  • Information regarding the estimated number of devices distributed under an EUA currently in U.S. distribution.
  • A benefit-risk based plan for disposition of distributed product as detailed in the draft guidance.
  • A plan on how the manufacturer would cease distribution of their product should they receive a negative decision from the FDA.

Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency (PHE)

Day 0: A Final ruling will be issued by the FDA ending the Public Health Emergency and changing the enforcement policies, but the trade community will still have the 18o day time period to become compliant with the “new” laws and regulations.

By Day 90:

• FDA recommends that manufacturers of certain life-supporting or life-sustaining devices submit to FDA a “letter of intent”, with information regarding their intent to submit a marketing submission or not. The guidance recommends that manufacturers of such devices include in this notification,
  • General information (e.g., contact information).
  • The title of the relevant enforcement policy guidance.
  • Submission number(s) for related premarket submissions.
  • A list of all model numbers or other device identifying information.
  • Whether the manufacturer plans to submit a marketing submission.
  • If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plan to
    • discontinue distribution of the device
    • to restore the device to a previously FDA-cleared or -approved version (if applicable)
    • to provide a physical copy or electronic updated labeling
    • any other efforts to address or mitigate potential risks of devices that remain distributed after the transition period has ended and the guidances in List 1 of the draft guidance have been withdrawn.
• If the medical device was previously compliant before the declaration of the PHE, and a modified version was distributed after the declaration of the PHE the manufacturer should submit this information as a premarket notification ( i.e., 510(k)) or premarket approval application (PMA) “amendment” to the manufacturer’s existing device submission that was previously cleared or approved.
• FDA recommends that manufacturers notate the following on the cover letter of the submission: “Attention: Notification of Intent”.

By Day 180: Manufacturers should have a marketing submission submitted and accepted by the FDA, meaning FDA has confirmed receipt of the marketing submission.

• The marketing submission/transition implementation plan should address and include:
  • The manufacturers’ plans for devices already distributed in the case of a positive decision or a negative decision.
  • Information regarding the estimated number of devices distributed under the enforcement policy currently in U.S. distribution.
  • A benefit-risk based plan for disposition of distributed product as detailed in the draft guidance.

Moving Forward 

If you do not submit a notification of intent or a marketing submission the FDA is interpreting this as your responsibility to cease distribution of your product. A failure to do so, could leave YOU open to enforcement from the FDA. For scenarios not addressed throughout the transition plan, the FDA allows for manufacturer-initiated discussions with FDA to resolve any issues with medical device registrations. The FDA also invites the trade community to submit comments on these draft guidances before its March 23, 2022 deadline. Please contact us at info@diaztradelaw.com for help submitting your comment!

To receive an email notification whenever a new post is published, please subscribe to our weekly blog here.

Did you know FDA has issued 1,569 enforcement actions against  medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

Register today to to hear directly from DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally market a medical device and best practices for avoiding and responding to enforcement actions.

Why Should I Register for this Webinar?

The FDA is actively enforcing its laws and regulations against non-compliant importers of medical devices. In FY21 alone the FDA has issued 53 warning letters  against medical devices companies.  Manufacturers, repackagers, relabelers, importers, and others engaged in the production or sale of medical devices must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, import alerts, seizures, voluntary recalls, injunctions, and criminal prosecution.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Warning Letters issued in FY21:

• Of the 53 warning letters issued to medical device companies in FY2021, 50% of these warning letters were issued against firms that marketed their medical devices as devices that treat or mitigate Covid-19. FDA found these devices (including  “KN95 Face Mask” and “3-ply Surgical Mask Disposable Face Mask”) to be “Unapproved Drugs, Misbranded, and/or Adulterated Products Related to Coronavirus Disease 2019 (COVID-19)”.
• In FY21, FDA warning letters have been issued against firms for offering medical devices for sale in the United States without marketing approval, clearance, or authorization from the FDA as well as poor current Good Manufacturing Practices (cGMPs).
• Interestingly enough 40 of the 52 warning letters were against U.S. and Chinese companies.

Recalled Medical Devices in 2020 and 2021:

• In FY21, FDA has recalled a total of 2161 medical devices, including the recall of 132 Class I devices, 1986 Class II devices, and 43 Class III devices have been recalled in FY21! 
• In FY20 a total of 3042 medical devices were recalled. 
• There are a total of 304 firms currently performing medical device recalls. Don’t be one of them!

In this webinar, you will receive an overview of FDA regulations and requirements for importing medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device. The objective of the webinar is to teach participants how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of medical devices are encouraged to attend either live on August 25, 2021 at 12:00 PM, or on demand thereafter. Register Here!

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

• FDA has updated Import Alert 66-41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62-08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!

Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun’s ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

• Register with the FDA;
• Foreign Manufacturers Must Name a U.S. Agent;
• Manufacturers Must List Their Devices With FDA;
• Manufacturers Must Meet Quality System (QS) Requirements Set Forth In 21 CFR 820,
• The Lens for Spectacles And/or Sunglasses Must Be Certified As Impact Resistant Under 21 CFR Part 801.410.

Registration & Device Listing with the FDA

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of sunglasses intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (21 CFR 807). Registration and listing provide FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.

The schedule of annual registration user fees for fiscal year 2019 is:

The device listing requires the Class of the product and the product code. The following regulation numbers and product codes are for sunglasses:

• Class I, II, III: What Class is your medical device?

The FDA categorizes medical devices into three different classes, pursuant to 21 CFR Parts 862-892. FDA determines the level of regulatory control for each class.

• Class I items are subjected to the lowest level of scrutiny because they present a low level of risk.
• Class II devices require a Premarket Notification (510(k)) because they exhibit a moderate level of risk.
  • “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.”
  • 21 C.F.R. §807 states the requirements that meet a 510(k) submission. After properly submitting the 510(k), you should receive an FDA letter informing you that the device is substantially equivalent to a legally marketed device. Then you may commercially distribute the device in the United States.

Class III devices are used to support or sustain life and are held to the most stringent level of regulatory controls: requiring a premarket approval (PMA).

• Product Code
  • The Product Code is assigned to the medical device according to the classification of the device. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892. the product code assists CBP officers, FDA officials, importers, and etc. in accurately identifying the class in which the medical device falls under and in tracking the medical device. For sunglasses (Non-Prescription Including Photosensitive), the Product Code is HQY. Below is the product classification as provided in FDA’s medical device database:

Good Manufacturing Practices/Quality System Requirements

GMP/QS requirements are found 21 CFR 820, Quality System Regulation. The quality system regulation includes requirements related to methods used and the facilities and controls for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. FDA’s has a helpful guidance document entitled, Quality System.

The Impact or Drop Ball Test

Upon importation, The FDA will work with U.S. Customs and Border Protection (CBP) by reviewing the entry to confirm the proper documentation was transmitted to CBP. A critical document FDA expects to be included with your entry packet is the “Drop Ball Test” certificate. A certificate illustrating the lens’ compliance with the 21 CFR 801.410 should accompany each lot of sunglasses seeking entry into the U.S. The certificate should reflect that the eyewear have been “sampled” and are impact resistant, using a statistically significant method.

FDA requires, pursuant to 21 CFR 801.410, that your sunglasses products pass the impact or drop ball test.  This test consists of a non-restricted steel ball being dropped on your sunglasses to test whether the sunglass fractures. The point of the test is to determine the level of performance of the sunglass.

A failure to include the “Drop Ball” certificate with your entry can result in a delay in your shipment by the FDA. To avoid any delays, make sure the Drop Ball Test results are attached to your shipping documents.

Import Alert 86-07: FDA Enforcement Actions for “Drop Ball” Certificate that Failed to Meet US Standards

Most recently, FDA issued Import Alert 86-07 in 2018 allowing for the detention without physical examination of sunglasses and eyeglasses manufactured by certain establishment listed on the Red List of Import Alert 86-07. The FDA Division of Imports (DIO) instructed FDA district offices to detain without physical inspection products from the manufacturers identified in the Red List for this import alert as their impact-resistant lenses in eyeglasses and sunglasses were analyzed by the FDA and were found to not be in accordance with 21 CFR 801.410. Note that while most import alerts are country-specific, Import Alert 86-07 is world-wide; meaning importers sourcing from any country must confirm their manufacturer impact testing meet FDA standards.

Unique Device Identification

Lastly, FDA requires a unique device identification (UDI). This is “designed to adequately identify devices through distribution and use.” 78 FR 58786. As a result of the UDI Rule (78 FR 58785), each device, label, and package requires its own Unique Device Identification (unless an exclusion has been granted). UDI’s are comprised of a combination of numeric and alphabetic variables, representing a (1) device identifier and (2) production identifier:

1. A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device (see 21 CFR 801.3), and
2. A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
   1. the lot or batch number within which a device was manufactured;
   2. the serial number of a specific device;
   3. the expiration date of a specific device;
   4. the date a specific device was manufactured; or/and
   5. the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.

How to Obtain a UDI?

There are very specific technical requirements for UDIs. These requirements are set forth in 21 CFR §830.20. The technicality of the 21 CFR §830.20 led FDA to mandate that UDIs must be issued under a system operated by an FDA-accredited issuing agency and conform to certain international standards incorporated by reference in the UDI Rule under 21 CFR §830.10. It is critical that the FDA-accredited issuing agencies’ systems for issuing UDIs align with the UDI labeling requirements to ensure labelers to confidently use the FDA-accredited issuing agency’s system to develop UDIs that are in compliance with the UDI labeling requirements under 21 CFR §801.

How Can Diaz Trade Law Help You?

DTL assist large, medium, and small importers with FDA compliance and enforcement actions. If you are new to the importation of sunglass, we highly recommend a consultation with our firm as you want to ensure your goods are not detained upon importation and that your manufacturer stays off Import Alert 86-07. Diaz Trade Law provides expert advice on how to pre-comply with both CBP and FDA before you import your sunglasses.

One might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.

The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.

What is a Medical Device?

The technical definition of a medical device, found in section 201(h) of the Federal Food Drug & Cosmetic Act (FD&C Act) is:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

2) 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

3) 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.

If you are asking how you would know if your product fits that definition, keep reading. You could check the official National Formulary, or the United States Pharmacopoeia. If you do not have either book handy, the next step is to think about what your product is used for. For example, if you wanted to know whether or not contact lenses were considered a medical device by the FDA, you could first consider what contacts are used for. Dictionary.com defines contact lenses as “plastic disks that are held in place over the cornea by surface tension and correct vision defects inconspicuously”[1]. Utilizing this definition, contact lenses can be used to affect the function of a persons eye sight, or used therapeutically to assist in the treatment of an eye disease. We would then look back at the technical definition of a medical device, and realize contact lenses can fit in either (2) or (3) above, and would therefore fit into FDA’s definition of a medical device.

There is another way to go about this. This way is not foolproof, but it is not a bad place to start. The FDA has a “Classification Database,”[2] where you may search to see how medical devices are classified by the FDA. You can also utilize this website to work backwards to see if your product is regulated by the FDA as a medical device. For example, if you were to type “contact lens” in the search box, we would see “22 records meeting your search criteria returned – contact lens”. From the search result, it is a safe assumption that contact lenses are treated as a medical device by the FDA. The database contains other technical information, which will be discussed in Part 2 of this series, including the product code and device class.

Otherwise, consider consulting an experienced import compliance attorney already familiar with the process for a legal opinion.

FDA’s regulation of Medical Devices

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. FDA regulates medical devices to assure the products safety and effectiveness. FDA’s legal authority to regulate medical devices stems from the FD&C Act. The FD&C Act contains requirements, which specify what level of control FDA will have over medical devices. The FDA implements regulations to implement the provisions of the FD&C Act. These regulations are initially published in the Federal Register (FR) for public comment. FDA reviews the public comments, and then issues a final regulation. The FR contains both the proposed and final regulations. Final regulations are subsequently placed or codified into the Code of Federal Regulations (CFR) on an annual basis. Most of FDA’s medical device regulations may be found in Title 21 CFR Parts 800-1299.

Conclusion

Now you can determine whether or not your product is in fact a medical device, and have an understanding of FDA’s regulation of medical devices. Stay tuned to learn more about FDA’s classes of medical devices, and the FDA registration process. For more information, please contact us at info@diaztradelaw.com or 305-456-3830.

[1] http://dictionary.reference.com/browse/contact%20lens

[2] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

• Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
• Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
• Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
• The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

Ultimately a Device Manufacture has three options to choose from:

1. Do not use symbols
2. Use symbols with adjacent explanatory text, or
3. Use stand-alone symbols

What are “stand-alone symbols”?

• Symbols established in a standard developed by a standards development organization (SDO).
• FDA stress that “it’s critical that symbols on medical devices are understood by the individuals who use them.”
• FDA provides the example where manufacturers of sterile syringes could opt to use the symbol for “do not reuse” on a syringe package without adding the actual words “do not reuse” to the package.

What is required to qualify for use of “stand-alone symbols”?

• Under the final rule there are two possibilities to permit a medical device label to carry “stand-alone symbols” without adjacent explanatory text.

1. As long as the standard symbol is recognized by FDA under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(c)) and the symbol is used according to the specifications for use of the symbol set forth in FDA’s section 514(c) recognition, OR

2. If the symbol is not included in a standard recognized by FDA under section 514(c) or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act (21 U.S.C. 352(c)) and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard.

• In either case, the symbol must be explained in a symbols glossary that is included in the labeling for the medical device and the use of symbols must also comply with other applicable labeling requirements in the FD&C Act.

Who benefits from the Use of Symbols in Labeling Final Rule?

• Device Manufacturers
• Importers
• International trade community

Manufacturers or Importers who have questions about implementing the Symbols final rule are encouraged to contact our office at info@diaztradelaw.com or 305-456-3830.

More information is available at:

Medical Device Registration Made Easy!

Frequently Asked Questions