The U.S. Food and Drug Administration (FDA) recently published a draft guidance on how to determine whether a business is a “small business” under the Preventive Controls for Human and Animal Food Rules. The rules define a “small business” as having fewer than 500 “full-time equivalent employees.” Small businesses are subject to different compliance deadlines and, in some cases, different requirements than other businesses sizes. The recent guidance demonstrates that the definition of full-time equivalent employee may exclude many facilities from small business classification.
What is a Full-time Equivalent Employee?
As outlined by 21 CFR Part 117, the number of full-time equivalent employees for a given facility is determined by dividing the total number of hours worked in one year by all of the business’s staff (including those that do not handle food and those employed by affiliates and subsidiaries) by the number of hours one full-time employee would work in one year (i.e. 2,080).
For example, a facility may employ 150 full-time employees at 40 hours per week and 200 part-time employees at 30 hours per week for food manufacturing roles (a total of 624,000 hours in a year). The facility may be a division of a legal entity that employs 150 full-time employees and an additional 250 part-time employees across multiple subsidiaries for various roles unrelated to food manufacture (an additional 702,000 hours in a year). Though the facility only has 150 full-time employees, the legal entity it comprises actually has 637 full-time equivalent employees (1,326,000 hours divided by 2,080).
For this reason, some facilities may not realize that they are actually subject to requirements for large businesses under the Preventive Controls Rules.
How Does Business Size Affect Preventive Controls Requirements?
The rules provide small businesses a longer timeframe than their larger counterparts to develop written Food Safety Plans required by the Preventive Controls Rules; however, the compliance deadlines for most food facilities have passed, and small animal food businesses only have until September 17, 2018 to comply with preventive control requirements.
Certain farms that engage in activities requiring FDA registration (e.g. processing) may be exempt from requirements under the rule if they are considered a small business, but large farms that engage in these activities are required to have Food Safety Plans in place.
Additionally, “very small businesses” (defined by the rules as averaging less than $1,000,000 per year in sold and unsold products during the preceding three-year calendar period) are required to submit a “Qualified Facility Attestation” to FDA. These facilities receive modified preventive controls requirements, including exemption from developing Food Safety Plans. Facilities who submit an attestation must ensure that the average value per year of their sold and unsold products does not exceed $1,000,000, or they may be providing false statements to FDA. Submitting false statements to a U.S. federal agency is a criminal offense.
It is wise for covered facilities to develop Food Safety Plans immediately. FDA may look for a Food Safety Plan as part of a routine facility inspection, and U.S. importers may request their suppliers’ Food Safety Plan as part of a required supplier approval process.
Registrar Corp’s Food Safety Specialists are Preventive Controls Qualified Individuals (PCQIs) who can develop a Food Safety Plan for your facility or review your current plan for compliance. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours-a-day at www.registrarcorp.com/livehelp.
The U.S. Food and Drug Administration (FDA) recently released numerous regulatory guidances to help the food and beverage industry comply with labeling rules. Registrar Corp has compiled some important developments below.
- FDA published a small entity compliance guide explaining requirements for aspects such as dual-column labeling and serving sizes under one of the label rules finalized in 2016. Many businesses must comply with new food labeling rules by January 1, 2020.
- FDA released an updated guidance explaining requirements for honey labeling.
- FDA released an updated list of example products to use as a reference for understanding product categories in the reference amounts customarily consumed table.
Of notable significance, FDA announced intention to exercise enforcement discretion on the use of a “†” symbol immediately following the “added sugar” percent daily value declaration on labels of pure honey, pure maple syrup, and certain cranberry products.
Manufacturers of pure honey and pure maple syrup may use the “†” symbol to reference a statement explaining that these sugars are naturally occurring and were not added during processing. Meanwhile, certain cranberry products may bear a statement explaining that the sugars are used to improve the palatability of the food and “[do] not exceed the amount of total sugars in comparable product[s] with no added sugars.”
The guidance was issued in response to industry concern that classifying sugars in these foods as added sugars would imply that the products have been rendered unhealthy with additional sweeteners or “are less nutritious than competitive products that have similar amounts of total sugars and nutrients.”
FDA labeling requirements can be complicated. If you do not want to navigate them on your own, Registrar Corp’s Regulatory Specialists can review your labeling and product ingredients for compliance with FDA regulations. For more information about FDA labeling requirements, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
*Update: In April 2018, FDA extended the eCTD compliance date for Type III DMFs to May 5, 2019.
Beginning May 5, 2018, the U.S. Food and Drug Administration (FDA) will require electronic common technical document (eCTD) format for all new Drug Master File (DMF) submissions, including reports and amendments. FDA states that it will reject DMF submissions not in eCTD format following this deadline.
What is eCTD?
eCTD is currently FDA’s standard submission format for new drug applications (NDAs), investigational new drug applications (INDs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs). FDA states that DMFs are typically submissions to these applications and, as such, are subject to electronic submission required by section 745A(a) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
After the deadline, FDA will require users to submit DMFs in the eCTD version supported by the FDA Data Standards Catalog. Additionally, an April 2017 FDA guidance document establishes technical specifications for aspects such as submission structure, file formats and versions of submission components, and required locations for datasets and study information.
Existing DMFs that are not in eCTD format, including those in paper form, do not require resubmission; however, additional submissions such as annual reports, supplements, and amendments to these DMFs must be submitted through ESG in eCTD. Existing paper DMFs voluntarily converted to eCTD will retain their current DMF number. Companies typically convert their existing paper DMFs to eCTD to expedite the review process of a NDA or ANDA that references the DMF.
How Do I Send an eCTD Submission?
eCTD submissions 10GB or smaller must be sent through FDA’s Electronic Submissions Gateway (ESG). Prior to accessing ESG, a user must request an application number from FDA, register for an ESG account, and configure their computer to communicate with the gateway. FDA advises users to perform a series of tests prior to submission. The process for ESG access may require several weeks.
Alternatively, you can make the process quick and easy by having a Regulatory Specialist, such as Registrar Corp, convert your DMF submissions to eCTD format and submit them to FDA through ESG. For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day: www.registrarcorp.com/livehelp.
The U.S. Food and Drug Administration (FDA) removed 2,546 medical device establishments from its active registration database. As of February 19, 2018, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on February 2, 2018.
Why Were These Registrations Removed?
Establishments are typically removed due to failure to renew their annual FDA registrations. FDA requires medical device establishments to renew their registrations between October 1 and December 31 of each year. Within two or three months, FDA typically removes any establishments that do not properly renew.
Establishments located outside of the United States must designate a U.S. Agent for FDA communication as part of their annual registration. During the recently passed renewal period, listed U.S. Agents were required to confirm their designation with FDA. If a U.S. Agent failed to confirm their designation, FDA did not consider the establishment’s registration complete.
Marketing a medical device in the United States without a valid FDA registration is a prohibited act that may result in detention or refusal of shipments and other FDA enforcement actions. Many establishments do not realize that their FDA medical device registration is invalid until their shipments are detained.
Registrar Corp can verify that your FDA medical device registration is valid for 2018 at no cost. Simply complete the form below. For questions or assistance with FDA medical device regulations, call: +1-757-224-0177 or chat with a Regulatory Advisor 24/7: www.registrarcorp.com/livehelp
Verify your FDA Registration:
Online vendors such as Amazon require documentation of a U.S. Food and Drug Administration (FDA) accession number for certain laser products sold through their online platforms. An accession number is a unique identifier that FDA uses to track reports from specific models of radiation-emitting electronic devices (RED). FDA requires manufacturers of certain RED products to have an accession number for their product prior to marketing it in the United States.
How Do I Get an Accession Number for my Laser Product?
In order to obtain an accession number, FDA requires manufacturers of most laser products to submit a product report consisting of numerous aspects including:
- Identifying information for the product and manufacturer
- Information on components and accessories, as well as functions and uses that may affect the product’s radiation emissions
- Measures taken to control levels of radiation in the product
- Warning statements and instructions for use related to the product’s radiation safety
After a manufacturer submits a report, FDA issues an acknowledgement letter containing the product’s accession number. The letter does not constitute FDA approval of the device.
When a business has an accession number for a laser product, FDA further requires annual reporting for the product to be submitted by September 1st of each year. Among other aspects, annual reports must contain a description of quality control procedures for the device, as well as test results and copies of communications relating to radiation safety of the device.
FDA reporting requirements apply to most laser products a business may want to sell through online vendors. Even products as seemingly harmless as spinning tops with laser lights and laser cat toys are subject to reporting. Failure to report may not only prohibit the sale of your product through Amazon and similar platforms, but may also result in detention of your shipments at the U.S. border.
For companies considering selling laser products through Amazon, Registrar Corp’s Regulatory Specialists can help determine the specific requirements for your product and facilitate reports with FDA. If you are located outside of the United States, Registrar Corp can also serve as your U.S. Agent for Service of Process. Simply complete the form below or call us at +1-757-224-0177. Alternatively, you can chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
Medical device manufacturers commonly question whether the U.S. Food and Drug Administration (FDA) considers their product a medical device “component” or “accessory.” Given that accessories can be classified separately from the parent devices they function with, the distinction is important. In December, FDA issued a guidance on accessory classification policy that helps clarify this distinction.
Component or Accessory? What is the Difference?
CFR 21 820.3(c) defines a “component” as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.” For example, a stethoscope contains multiple parts, including a diaphragm, bell, and tubing. When packaged in whole with the stethoscope, these parts would be considered medical device components that comprise a finished medical device.
In contrast, FDA clarifies that an “accessory” is a separate, finished device intended to “support, supplement, and/or augment the performance” of at least one parent device. Accessories might be marketed individually for use with a specific device type and may be a different class than their parent device.
For instance, an endoscope, which is used to examine a patient’s internal organs, receives its own medical device classification. An individually marketed endoscopic snare may be attached in order to remove harmful objects from a patient during endoscopy. Because the snare is marketed for intended use with a parent device and it supplements the parent device by adding functionality, the device would likely be considered an accessory.
Likewise, cushions for motorized wheelchairs are often marketed separately with the intent to address specific physiological concerns of the device user. The cushion augments the parent device by improving convenience for the device user. While the motorized wheelchair may be a class II device, the cushion may present lower risk when used with the parent device. Dependent on FDA’s assessment of this risk, the cushion might be considered a class I medical device accessory, subject to different requirements than its parent.
FDA’s New Accessory Classification Process
FDA generally determines classification of accessories in one of two ways. An accessory may be included in the same classification as its parent device through 510(k) Premarket Notification, Premarket Application, or express inclusion in the classification regulation of the parent device. Other cases may involve the issuance of a separate classification regulation when FDA considers an accessory to have a different level of risk than its parent device.
The FDA Reauthorization Act of 2017 allows for the classification of accessories based upon the level of risk posed when used as intended and the level of regulatory controls necessary to provide reasonable assurance of safety and effectiveness. Manufacturers may now submit an Accessory Classification Request to FDA to receive appropriate classification of their device accessory. An Accessory Classification Request includes a proposal to FDA that, among other aspects, identifies the accessory, the proposed class of the accessory, and the necessary information to establish the risk the accessory poses.
Medical device classification serves an important role in deciding a device’s FDA requirements, such as the premarket processes it may be subject to or when it is required to comply with certain regulations. Lower device classes may even receive exemption from certain premarket requirements.
For proper accessory classification, Registrar Corp’s Regulatory Specialists can guide you through compiling the documentation required for a FDA Accessory Classification Request. Additionally, if you manufacture an accessory and would like to preserve trade secrets from the manufacturer of the parent device, we can assist in the submission of a Medical Device Master File to FDA. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
On January 2, 2018, the U.S. Food and Drug Administration (FDA) removed all drug establishments that did not renew their FDA registrations for 2018 from its active registration database. The Agency also removed all uncertified drug product listings from publication.
- FDA removed 1,256 of the 10,496 drug establishments in FDA’s database as of December 31, 2017 (12%)
- FDA removed 30,786 of the 118,255 drugs listed in FDA’s database as of December 31, 2017 (26%)
Companies that would like to verify that their drug establishment registrations or drug product listings are active with FDA can do so at no cost using the following links:
Annual FDA Drug Establishment Registration
FDA requires registered drug establishments to renew their registrations between October 1 and December 31 each year. Those that fail to renew by the deadline are removed from FDA’s database, and drugs manufactured in unregistered facilities are considered misbranded. Marketing misbranded drugs in the USA is a prohibited act that may be met with seizure and injunction.
Registrar Corp can verify whether your registration was properly renewed at no cost. Verify your registration now.
New “Blanket No Change Certification” Requirements for Drug Product Listings
FDA requires drug establishments to report any changes to product listings in June and December each year. Until recently, unchanged listings required no action. FDA introduced a change for the 2017 renewal period requiring registered drug establishments to submit a “blanket no change certification” in structured product labeling (SPL) format for all drug listings that required no updates within the year. Unchanged listings that were not properly certified during the 2017 renewal period were removed from publication, making it a prohibited act for those products to be marketed in the USA.
Registrar Corp can verify whether your listings are currently on file with FDA at no cost. Verify your listings now.
Registrar Corp is a U.S. FDA consulting firm that helps drug establishments comply with FDA regulations. Registrar Corp assists with FDA registration, drug product listings, drug labeling, drug master files (DMFs), and more. For questions or assistance, visit www.registrarcorp.com, call +1-757-224-0177, or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
This article was originally published as a press release.
The medical device and drug industries saw numerous regulatory developments in 2017. The U.S. Food and Drug Administration (FDA) introduced new requirements, fees, deadline extensions, and exemptions. Below, Registrar Corp provides an overview of regulatory highlights this year.
FDA Removed Medical Device and Drug Establishments that Did Not Register for 2017
Medical device and drug establishments that failed to properly renew their registrations for 2017 were removed from FDA’s active registration database. The Agency will likely do the same in 2018. Marketing medical devices and drugs without a valid registration is a prohibited act that may be met with seizure and injunction.
FDA Extended the UDI Compliance Date for Class I Devices to 2020
FDA issued a letter in June announcing its intention to extend the universal device identifier (UDI) compliance dates for class I and unclassified devices. The letter proposes to push the UDI labeling compliance date for these devices to September 24, 2020.
FDA Exempted Certain Class II Devices from 510k
In July, FDA exempted certain class II medical devices from premarket notification (510k) requirements. The exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.” View a list of the exempt devices here.
The Compliance Date Passed for the Consumer Antiseptic Wash Final Rule
As of September, over-the-counter (OTC) consumer antiseptic washes containing any of nineteen certain ingredients are not permitted to enter interstate commerce without approval of a new drug application (NDA). FDA made this determination after discovering there was insufficient evidence to support the ingredients’ safety and effectiveness for their intended use.
FDA Published FY 2018 User Fees for Medical Devices and Generic Drugs
The Medical Device User Fee Amendments (MDUFA) and Generic Drug User Fee Amendments (GDUFA) were reauthorized for fiscal year (FY) 2018. The amendments introduced differences in rates from FY 2017, as well as new types of fees for certain facilities and submissions.
View the list of fees for medical device establishments here.
View the list of fees for drug establishments here.
FDA Introduced a New Verification Requirement for U.S. Agents of Medical Device Establishments
The U.S. Agent of medical device establishments located outside of the United States is now required to confirm this role with FDA. Agents must accept their designation through the FDA Unified Registration and Listing System (FURLS). If the Agent does not respond to a verification email within ten days, the establishment will need to designate a new Agent.
FDA Introduced Annual Certification Requirement for Unchanged Drug Listings
The 2017 registration renewal period introduced a requirement for drug establishments to submit a “blanket no-change” certification for drug listings that did not receive any changes to data or labeling during the year. Certifications must be submitted in structured product labeling (SPL) format.
FDA Published Final Guidance for UDI Direct Marking Requirements
In November, FDA issued a final guidance to clarify a device labeler’s responsibilities for UDI direct marking requirements. Class II devices must comply with direct marking requirements by September 24, 2018. During a December webinar, FDA stated that they do not intend to enforce these requirements for class I and unclassified devices until September 24, 2022.
FDA Issued a Final Rule on the Safety and Effectiveness of Triclosan in Health Care Antiseptics
FDA finalized a rule prohibiting the use of Triclosan and 23 other active ingredients in OTC antiseptics for health care environments. After December 20, 2018, health care antiseptics containing these ingredients will not be permitted to enter interstate commerce without FDA approval of an NDA.
As we cross into 2018, Registrar Corp will continue to keep the medical device and drug industries informed about important FDA regulations. For assistance with FDA requirements in either industry, call us at +1-757-224-0177, or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
2017 brought a host of changes for food manufacturers and importers. The U.S. Food and Drug Administration (FDA) had a year of announcements, proposals, and deadlines for the food and beverage industry. Perhaps most notable were the passing of two compliance dates for rules under the Food Safety Modernization Act (FSMA) and a proposed extension of the compliance date for FDA’s new food label rules. Take a look below at some of the regulatory highlights that occurred this year.
FDA Removed 28% of Food Facility Registrations from its Database
Between January 2016 and February 2017, FDA removed 57,720 food facility registrations from its database. The drop in registrations was likely caused by facilities not properly registering before the December 2016 deadline and U.S. Agents of foreign facilities not confirming acceptance of this role with FDA.
Australia Received Systems Recognition with U.S. FDA
In April, FDA recognized the Australian Department of Agriculture and Water Resources as having a comparable Food Safety System to the United States. Australia follows New Zealand and Canada as the third country to receive this recognition. U.S. Importers may receive exemptions from certain requirements in their Foreign Supplier Verification Programs (FSVPs) if their suppliers are in “good compliance standing” with a recognized country’s regulating authority.
As of this writing, the three recognized countries have not published lists of firms in good compliance standing. As a result, suppliers in these countries are unable to benefit from the competitive advantage that more relaxed FSVP requirements for importers would grant them.
The FSVP Compliance Deadline for Most US Importers Passed
The first compliance deadline for the FSVP Rule passed on May 30, 2017. Among other requirements, covered importers must monitor and document their foreign suppliers’ FDA compliance, evaluate the level of health risk their suppliers pose, and conduct appropriate verification activities relative to this evaluation. In August, FDA began inspecting covered importers for their compliance with FSVP requirements. The next FSVP compliance date is March 19, 2018.
Compliance Dates Passed under the Preventive Controls Rules
Larger animal food and smaller human food businesses were required to develop and implement written Food Safety Plans by September 18, 2017. These plans, overseen by a “Preventive Controls Qualified Individual” (PCQI), involve an analysis of reasonably known or foreseeable hazards and preventive controls for these hazards. Smaller animal food businesses were required to begin implementing Current Good Manufacturing Practices (CGMPs) by this deadline.
FDA Proposed Extension of Label Rule Compliance Dates
In September, FDA proposed an extension of the compliance deadline for new food labeling rules to January 1, 2020 for food manufacturers grossing $10 million or more in annual sales. Smaller businesses would be provided an additional year. Despite the proposed extension, we urge facilities to take steps toward compliance now. FDA issued this proposal after manufacturers expressed concerns over being able to comply with the initial deadline of July 2018.
FDA Proposed to Revoke Authorized Health Claim for Soy Protein
FDA issued a proposal to revoke an authorized health claim linking soy protein to a decreased risk of coronary heart disease. Since the claim’s authorization in 1999, the “totality of scientific evidence” surrounding the relationship has yielded inconsistent findings. This caused FDA to determine that it did not present the significant scientific agreement required of an authorized health claim.
FDA Issued Draft Guidance for Refusal of Inspection
In December, FDA issued a guidance outlining the Agency’s interpretation of the term “refusal of inspection.” FDA states that, among other actions, failure to respond to an inspection request within 24 hours may constitute a refusal. Food facilities that refuse inspection are placed under Import Alert, and their products are refused at the port of U.S. entry.
Registrar Corp remains committed to keeping the food industry informed on pressing regulatory matters and will continue to issue critical information in 2018. The numerous requirements that came into effect this year and those approaching in 2018 may be overwhelming. Registrar Corp can offer assistance. Call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments. Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will not be permitted to enter interstate commerce without FDA approval of a new drug application (NDA). You will find a list of the covered ingredients below.
The scope of this rule only applies to antiseptic products (i.e. washes, scrubs, rubs, and skin preparations) used by health care professionals in health care settings. Antiseptic products intended for use by consumers are covered by two separate rules, one of which had a compliance deadline in September 2017.
Why are these ingredients prohibited?
The covered ingredients were initially part of a 1994 tentative final monograph for OTC antiseptic drug products. A 2015 proposed rule called for additional data to support the safety and effectiveness of these ingredients for use in health care antiseptic products. FDA did not receive any additional data, and the available scientific evidence surrounding the ingredients was insufficient to support a determination that they are generally recognized as safe and effective (GRASE).
FDA is delaying final rulemaking for at least one year on benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also known as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. The Agency has stated that a determination for these ingredients will be dependent upon whether ongoing studies are eventually completed, and if so, when they are completed.
Not sure how this rule applies to your health care antiseptics? Registrar Corp’s Regulatory Specialists can conduct a full review of your antiseptic product’s ingredients and labeling. We review your product’s active ingredients to ensure that they conform to the requirements specified in the applicable FDA monographs for antimicrobial drug products. We also inspect your labeling to ensure that its content and formatting conform to numerous FDA drug regulations. In addition to an extensive report of suggested revisions, you will receive a print-ready label incorporating these changes. For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.
Ingredients Deemed Not Generally Recognized as Safe and Effective under the Health Care Antiseptic Final Rule:
Iodophors (Iodine-containing ingredients)
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Iodine tincture USP
• Iodine topical solution USP
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Poloxamer—iodine complex
• Undecoylium chloride iodine complex
Combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative
Combination of mercufenol chloride and secondary amyltricresols in 50 percent alcohol