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FDA Publishes FY 2019 Medical Device and Generic Drug User Fees

The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2019 fee schedules for the Generic Drug User Fee Amendments (GDUFA) and Medical Device User Fee Amendments (MDUFA). FY 2019 rates for both amendments take effect on October 1, 2018. To keep industry updated on these requirements, Registrar Corp outlines upcoming changes to these fees below.

Fees for Drug Facilities
GDUFA requires user fees from certain types of drug facilities. On October 1, 2018, generic drug facilities are required to pay any applicable facility fees to FDA. Additionally, GDUFA requires fees for new Type II Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) submissions to FDA. You will find a table of these fees below.

Notable Changes to GDUFA in FY 2019

  • ANDA Program Fees – In FY 2018, FDA introduced program fees for ANDA holders. These facilities pay a user fee based on the number of approved ANDAs they hold on October 1 of a given year.  The FY 2019 ANDA program fees reflect an approximate 17% increase from the previous year.
  • Type II DMF Submission Fees – In FY 2018, the fee for a single Type II DMF submission to FDA was $47,829. FY 2019 will see an approximate 15% increase to $55,013.

You can view a comparison between the FY 2018 and FY 2019 GDUFA fees below:

FY 2019 GDUFA Fees

Fee Type 2018 2019
Facility Fees Domestic Foreign Domestic Foreign
Active Pharmaceutical Ingredient (API) $45,367 $60,367 $44,226 $59,226
Finished Dosage Form (FDF) $211,087 $226,087 $211,305 $226,305
Contract Manufacturing Organization (CMO) $70,362 $85,362 $70,435 $85,435
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) $1,590,792 $1,862,167
Medium (6 – 19 ANDAs) $636,317 $744,867
Small (5 or fewer ANDAs) $159,079 $186,217
Application Fees
ANDA $171,823 $178,799
Type II DMF $47,829 $55,013

Fees for Medical Device Establishments
MDUFA requires all FDA-registered establishments to pay a user fee during their annual registration renewal. The FY 2019 establishment registration fee for all establishments is $4,884.  According to the publication of MDUFA fees, FDA does not recognize an establishment as legally registered until this fee is paid.

Additionally, MDUFA requires fees for the submission of certain medical device applications to FDA.  Small businesses, defined by MDUFA as having gross sales or receipts of no more than $100 million during the most recent tax year, may qualify for discounts to application fees. All medical device application fees reflect an approximate 3-4% increase from the previous year.

You can view a comparison between the FY 2018 and FY 2019 MDUFA fees below:

FY 2019 MDUFA Fees

Fee Type 2018 2019
Annual Establishment Registration $4,624 $4,884
Application Fees Standard Small Business Standard Small Business
510(k) $10,566 $2,642 $10,953 $2,738
513(g) $4,195 $2,098 $4,349 $2,175
De Novo Classification $93,229 $23,307 $96,644 $24,161
PMA, PDP, PMR, BLA $310,764 $77,691 $322,147 $80,537
panel-track supplement $233,073 $58,268 $241,610 $60,403
180-day supplement $46,615 $11,654 $48,322 $12,081
real-time supplement $21,753 $5,438 $22,550 $5,638
BLA efficacy supplement $310,764 $77,691 $322,147 $80,537
PMA annual report $10,877 $2,719 $11,275 $2,819

Not sure which fees you may be subject to?  Registrar Corp’s Regulatory Specialists can help determine your applicable fees and facilitate payment with FDA.  Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

New Developments in UDI and GUDID Regulations

Registrar Corp is committed to keeping industry up to date on FDA’s Unique Device Identifier  (UDI) requirements and recently attended the 2018 UDI Conference in Baltimore. The following blog summarizes new and updated information related to UDI and Global Unique Device Identification Database (GUDID) regulations.

Background

In September 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, which requires most medical devices to carry a UDI. A UDI is a numeric or alphanumeric code consisting of a device identifier (DI) and a production identifier (PI) that must be placed on the device label and on the device packaging. The labeler is responsible for complying with this rule.

Compliance Deadlines

The compliance deadlines for Class II devices and for Class III devices have already passed. In June 2017, FDA informed industry that it intended to extend the compliance deadline for these devices due to complex policy and technical issues, among other things.  In January 2018, the Agency issued a guidance document detailing how it would utilize its enforcement discretion:

For Class I and unclassified devices manufactured and labeled on or after September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2020
  • Direct Marking requirements beginning September 24, 2022.

For finished class I and unclassified devices manufactured and labeled before September 24, 2018, FDA intends to enforce:

  • UDI labeling, GUDID Data Submission, and Standard Date Format requirements beginning September 24, 2021.
  • Direct Marking requirements beginning September 24, 2022.

 

Recent Enhancements and Fixes to GUDID Submission Process

 

GUDID Coordinators Now Able to Correct Errors After the DI Record Grace Period

The labeler of a device with a UDI is responsible for submitting information about the device to the Global Unique Device Identification Database (GUDID), a public database that contains important identification information about every device with a UDI. In order to ensure data quality, FDA has taken steps to make correcting errors by editing device records easier.

Previously, unlimited edits were only possible during the 30 day grace period following initial publication. After the grace period, edits could only be made through a difficult process. Now, the GUDID Coordinator user has the ability to “unlock” device records. Once previously submitted device records have been unlocked, errors may be corrected. It should be noted that the records’ history will be saved and the public will be able to see what edits have been made.

 FDA to make Premarket Numbers Public

FDA has announced plans to grant the public access to the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI). This data is tentatively scheduled to be made public on July 2, 2018. FDA recognizes that this information may be sensitive and will give labelers the option of keeping their premarket numbers confidential. Specifically, FDA will use the confidentiality information that is included in the device listing information submitted to the FDA Unified Registration and Listing System/ Device Registration and Listing Module (FURLS/DRLM). If a proprietary name is marked confidential in DRLM as part of the device listing information, then FDA does not plan to make the corresponding premarket numbers in GUDID DI record(s) public.

Labelers who would prefer to keep the their premarket numbers confidential may find it advisable to carefully scrutinize and potentially alter the confidentiality designations assigned to the DRLM proprietary names in their device listing records in order to ensure that these designations correspond to their preferences.

Meeting FDA GUDID and UDI Requirements

The deadlines for complying with FDA GUDID and UDI requirements are approaching or have already passed. Therefore, it is prudent for medical device labelers to take measures to ensure that they are in compliance with these complex regulations. Medical device labelers may wish to seek the assistance of Registrar Corp’s Regulatory Specialists, who possess expert knowledge of relevant FDA regulations and can provide guidance on which UDI deadlines and requirements apply to particular devices.

Registrar Corp can provide assistance  by acting as a facility’s Regulatory Contact for UDI purposes, submitting the required device information to GUDID on behalf of the labeler, or by altering the confidentiality information submitted to DRLM in order to ensure that premarket numbers remain confidential.

For more information, contact us by phone at +1-757-224-0177 or chat with a Regulatory Adviser 24 hours a day: www.registrarcorp.com/livehelp.

FDA Removed Nearly 10% of Medical Device Establishments from its Registration Database

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:

FDA Issues Guidance on Medical Device Accessories

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.

2017 in Review – U.S. FDA Medical Device and Drug Regulations

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.

Upcoming Changes to FDA Electronic Medical Device Reporting (eMDR) in 2018

Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury.  An “adverse event” is when a device has a malfunction that could cause death or serious injury.  Importers report this information to the manufacturer.  The U.S. Food and Drug Administration (FDA) has announced that it will update certain codes used for Adverse Event Reporting through the Electronic Medical Device Reporting (eMDR) system on April 6, 2018.

The Agency will replace the codes for FDA Device Problem, Manufacturer Evaluation Method, Manufacturer Evaluation Result, and Manufacturer Evaluation Conclusion with similar codes established by the International Medical Device Regulators Forum (IMDRF).

IMDRF has released public references to help map FDA codes to the new codes during the interim before the update.  For example, the current FDA Device Problem Code 2682 refers to an “issue associated with the interaction between the patient’s physiology or anatomy and the device that affects patient and/or device.” This code corresponds to and will be replaced by IMDRF code A0101, a “problem associated with the interaction between the patient’s physiology or anatomy and the device that affects the patient and/or the device.”

Despite this mapping, reporting parties will not be able to rely on FDA codes after the update.  Some IMDRF codes do not have a current FDA equivalent, and FDA has further stated that the submission of retired FDA codes following the update will be rejected by the eMDR system.   As such, reporting parties should familiarize themselves with the IMDRF codes for a smooth transition into these changes.

If you are a reporting party in need of assistance, Registrar Corp can guide you through the eSubmitter software and facilitate your Adverse Event Report submission to eMDR.  Registrar Corp offers Adverse Event Reporting assistance at no fee to clients of our U.S. Agent Service.  Call us at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Publishes Final Guidance for UDI Direct Marking Requirements

The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime.  This is known as UDI direct marking.  FDA recently published a final guidance on requirements for the direct marking of medical devices.

According to the guidance, the device labeler is responsible for direct marking a device with a UDI in either human readable or automatic identification and data capture (AIDC) format. The method of marking, such as etching or attaching a permanent tag, is decided at the labeler’s discretion and must account for wear from the intended use of the device.

What is New in the Final Guidance?

FDA recently conducted a webinar explaining the key differences between the final guidance of this regulation and the draft guidance published in 2015.  Notable changes include:

  • FDA established that a device is “intended to be reprocessed” if it is intended to undergo high-level disinfection and/or sterilization before or between each use. High-level disinfection is defined in this guidance as a process in which a sterilant kills “all forms of microbial life, except for large numbers of bacterial spores.”
  • FDA emphasized that implants, which are not mentioned in the draft guidance, do not fall within the scope of UDI direct marking regulation.
  • FDA does not intend to enforce UDI labeling and direct marking compliance for devices that were consigned or loaned to a healthcare facility before the devices’ respective UDI labeling compliance dates. This also applies to devices in the possession of a sales representative pending sale under the same conditions.
  • In June 2017, FDA issued a letter outlining intentions to extend the UDI labeling compliance date for covered class I and unclassified devices to September 24, 2020. During the webinar, the Agency clarified that it does not intend to enforce direct marking requirements for these devices until September 24, 2022.

Remaining Compliance Dates for UDI Direct Marking

Unless exempt from UDI direct marking requirements, the compliance date for class I and unclassified devices is as established above, and the compliance date for direct marking of class II devices remains September 24, 2018, as outlined in the UDI final rule.  Devices manufactured before their respective UDI labeling compliance dates are provided three additional years to comply with labeling and direct marking requirements.

Not sure how UDI requirements apply to your device?  Registrar Corp’s Regulatory Specialists can help determine whether your device requires direct marking and can submit device information to FDA’s Global Unique Device Identifier Database (GUDID).  For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

Additional UDI Resources: 

Five Steps to FDA UDI Compliance

How Many UDIs Will You Need?

UDI Labeler Responsibilities

FDA Unique Device Identifier Requirements

Medical Device and Drug Establishments Must Renew FDA Registrations by December 31, 2017

Medical device and drug establishments that produce and distribute products for sale within the United States are required to renew their U.S. Food and Drug Administration (FDA) registration annually.  Registrar Corp writes to remind the industries that registrations must be renewed for 2018 between October 1, 2017 and December 31, 2017.

Medical device establishments are required to designate an Official Correspondent for FDA communications in their registrations, while drug establishments must designate a Registrant Contact. Additionally, FDA requires all businesses located outside of the United States to appoint U.S. Agents.

Notices for Medical Device Establishments

While there are no major changes this year for drug establishments, medical device businesses should be aware of two important updates for their 2018 renewals:

  1. The 2018 user fee for medical device establishment registration is $4,624, a steep increase of $1242 from 2017. All medical device establishments that are required to register must pay this fee, regardless of whether or not they qualify as a small business for other medical device user fees.
  2. As mentioned previously, foreign medical device establishments are required to designate U.S. Agents in their registrations. The 2018 renewal period marks the first time that designated U.S. Agents must verify their agreement to serve this function.  Once an Agent’s information is entered into the FDA Unified Registration and Listing System (FURLS), the system will issue them a verification email.  Agents will have ten days accept their designation through FURLS.  If a device establishment’s U.S. Agent does not accept, a new Agent must be designated or the registration may be considered invalid for 2018.

Why Timely Renewal is Important

Failure to renew FDA registration can have adverse effects.  In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.

FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration.  Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed.  It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.

Registrar Corp can assist in the renewal of your medical device or drug establishment registration, facilitate payment of fees with FDA, and issue a third-party certificate that verifies your registration. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.

Renew a Medical Device Establishment Registration here.

Renew a Drug Establishment Registration here.

Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Publishes FY 2018 User Fees for Medical Devices and Generic Drugs

The Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendments (GDUFA) were reauthorized on August 18, 2017 to be in effect through September 30, 2022.  The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2018 fees for both MDUFA and GDUFA, introducing new types of fees and changes in rates from FY 2017.  All MDUFA and GDUFA fees begin on October 1, 2017.  To prepare medical device and drug businesses for these requirements, Registrar Corp outlines some notable changes to these amendments this year.

Fees for medical device establishments:

MDUFA requires a user fee from medical device establishments that register with FDA, as well as fees for certain applications, notifications, and other types of submissions filed on or after October 1, 2017.  Small businesses, defined for this regulation as having less than $100 million in gross sales during the most recent tax year, are eligible for reduced rates on most fees.  All other facilities are subject to a standard fee.  Some significant changes to MDUFA for this fiscal year are explained below.

Annual Establishment Registration – All medical device establishments that are required to register with FDA must pay the Annual Establishment Registration user fee.  The fee for this year is $4,624 (a $1,242 increase from FY 2017).  Unlike with other MDUFA fees, there is no waiver or reduction for small businesses.

510(k) Application – The standard fee for 510(k) applications sees an increase of $5,876 from the FY 2017 rate of $4,690 to $10,566.  Small businesses are required to pay $2642, facing an increase of $297 from the previous year.

De Novo Classification Application – New to the recent reauthorization of MDUFA is a fee for De Novo Classification applications.  A standard business that files an application following the start of FY 2018 is required to pay $93,229, while a small business pays $23,307.

Refer to the chart below for a detailed comparison of MDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 MDUFA Fees

Fee Type 2017 2018
Annual Establishment Registration $3,382 $4,624
Application Fees Standard Small Business Standard Small Business
510(k) $4,690 $2,345 $10,566 $2,642
513(g) $3,166 $1,583 $4,195 $2,098
De Novo Classification N/A N/A $93,229 $23,307
PMA, PDP, PMR, BLA $234,495 $58,624 $310,764 $77,691
panel-track supplement $175,871 $43,968 $233,073 $58,268
180-day supplement $35,174 $8,794 $46,615 $11,654
real-time supplement $16,415 $4,104 $21,753 $5,438
BLA efficacy supplement $234,495 $58,624 $310,764 $77,691
PMA annual report $8,207 $2,052 $10,877 $2,719
30-day-notice $3,752 $1,876 $4,972 $2,486

 

Fees for drug establishments:

GDUFA requires user fees for certain drug establishments producing active pharmaceutical ingredients (API) or finished dosage forms (FDF), the submission of certain drug master files (DMF) for generic drug products, and the submission of certain applications for generic human drug products.  New additions to GDUFA include abbreviated new drug application (ANDA) program fees and contract manufacturing organization (CMO) facility fees.  Some significant changes to GDUFA for this fiscal year are explained below.

Contract Manufacturing Organization Fees – For the recent GDUFA reauthorization, CMO facility fees apply to FDF facilities that are identified in at least one approved ANDA, but are not the ANDA holder or an owner or affiliate of the holder.  These fees are a two-thirds reduction of FDF facility fees for qualifying establishments.  Domestic CMOs are required to pay a user fee of $70,362, while foreign CMOs pay $85,362.

ANDA User Fees – The user fee for the submission of a single abbreviated new drug application (ANDA) has increased from $70,480 to $171,823.

ANDA Program Fees – Businesses holding ANDAs are now required to pay a user fee in relation to how many they hold.  The smallest ANDA program, with as little as one approved ANDA, begins with a user fee of $159,079.  A business holding between six and nineteen approved ANDAs is required to pay a medium program fee of $636,317. The largest program fee for businesses holding twenty or more approved ANDAs is $1,590,792.

Refer to the chart below for a detailed comparison of GDUFA’s fee changes between FY 2017 and FY 2018.

 

FY 2018 GDUFA Fees

Fee Type 2017 2018
Facility Fees Domestic Foreign Domestic Foreign
API $44,234 $59,234 $45,367 $60,367
FDF $258,646 $273,646 $211,087 $226,087
CMO N/A N/A $70,362 $85,362
ANDA Program Fees – Based upon the number of approved ANDAs held
Large (20 or more ANDAs) N/A $1,590,792
Medium (6 – 19 ANDAs) N/A $636,317
Small (5 or fewer ANDAs) N/A $159,079
Application Fees
ANDA $70,480 $171,823
Type II DMF $51,140 $47,829

Not sure which user fees you may be subject to? Registrar Corp’s Regulatory Specialists can help determine your relevant fees and facilitate payment with FDA.   Call us at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.

FDA Exempts Certain Class II Devices from Premarket Notification (510(k))

On July 10, 2017, the U.S. Food and Drug Administration (FDA) announced it is exempting or partially exempting certain class II devices from premarket notification (510(k)) requirements. According to FDA, the newly 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.”

What is a partially exempt device?

Certain devices are only exempt from 510(k) under the Federal Register if they meet criteria specified by FDA.  FDA created new product codes for listed devices that fit these criteria.  Listed devices that do not meet the criteria will continue to use the pre-existing product code. The criteria are included in the list. The majority of FDA’s partial exemptions are for products intended for employment and insurance testing.

What does this mean for medical device companies?

The new exemptions may prove to be a relief of regulatory burden that allows manufactures of affected devices to move forward with business in the United States.  510(k) requirements are often prohibitive for manufacturers; the regulations are extensive and the testing and research required can be expensive.

Manufacturers of devices subject to 510(k) requirements must prove to FDA that the devices are “substantially equivalent” to similar legally marked devices.   510(k) submissions must contain information such as proposed labeling and advertisements, a summary of the technological characteristics of the device, discussion of submitted tests, and much more.  There is no 510(k) form or template, but all information must be formatted as described in 21 CFR 807.

Manufacturers of 510(k) exempt devices are still subject to other FDA requirements for medical devices, such as annual registration and listing, UDI requirements, adverse event reporting, labeling requirements, and complying with good manufacturing practices.  Registrar Corp can assist manufacturers of newly exempt products to comply with FDA’s other regulations.

For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.