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The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly.  Under the U.S. Food and Drug Administration (FDA) final rule, Class II devices must be labeled with UDIs starting September 24, 2016.  FDA consulting firm Registrar Corp is providing tips to help labelers of Class II devices meet the impending deadline.

Tip 1: Determine the Labeler

FDA puts responsibility for UDI compliance on the “labeler” of a medical device.  FDA’s definition of a labeler can confuse companies trying to comply.  Typically, the labeler is the owner of the brand.  When the manufacturer does not own the brand, the manufacturer is likely not the labeler.  For example, if RegMed buys catheters from CBI Medical Products and markets the devices under RegMed’s brand, RegMed would likely be considered the labeler of the catheters. Click here for more information on identifying the labeler of a device.

Tip 2: Start Immediately

If you determine you are responsible for complying with FDA’s UDI requirements, it’s prudent to start as soon as possible.   Many aspects of UDI compliance can take substantial time to accomplish.  For example, FDA requires that device facilities obtain a DUNS number for UDI purposes.  DUNS numbers are free to obtain, but it can take Dun and Bradstreet weeks to issue a new number.  Registrar Corp can help facilities obtain a DUNS number free of charge.  Device labelers also are required to identify a Global Medical Device Nomenclature (GMDN) for each device they submit to FDA’s Global Unique Device Identification Database (GUDID).

Tip 3: Practice Makes Perfect

Submitting data into FDA’s GUDID can be time consuming and complicated.  FDA recommends that labelers using the agency’s web interface or the HL7 SPL method familiarize themselves with the system before submitting.  Web interface users may create draft submissions which are not visible to FDA.  Alternatively, Registrar Corp can submit device data to FDA’s GUDID on behalf of a labeler.

Tip 4: Appoint a Knowledgeable Regulatory Contact

FDA requires device labelers to designate a Regulatory Contact when creating a GUDID account.  FDA will contact this individual with questions regarding GUDID submissions as well as compliance and regulatory issues.  The Regulatory Contact speaks on behalf of the company, so it’s important to designate a professional familiar with FDA’s UDI rule.  Registrar Corp employs several UDI specialists and can act as a company’s Regulatory Contact.  As a company’s Regulatory Contact, Registrar Corp will setup the company’s GUDID account, help determine the UDI requirements applicable to the company’s specific devices, and facilitate communication between FDA and the company.

For additional guidance, see Ten Steps to Comply with FDA UDI Regulations.

This blog was originally published as a press release.

         

In 2011, President Obama signed FSMA — a body of regulatory works that quickly became the most sweeping reform of the U.S. food safety system in over 70 years — into law. The FDA published seven major rules under FSMA, each of which created new requirements that put more responsibility on industry to prevent contamination of the U.S. food supply rather than reacting to it. This article will review all of FSMA’s seven final rules and briefly cover points of compliance, as well as compliance dates.

Preventive Controls Rules for Human and Animal Food

Proposed: January 2013 (Human) and October 2013 (Animal)
Finalized: September 17, 2015
Compliance Dates:

  • Very-small businesses (businesses that have less than $1,000,000 in total annual sales of human food, adjusted for inflation): September 2018
  • Businesses subject to the Pasteurized Milk Ordinance: September 2018
  • Small businesses (businesses with fewer than 500 full-time equivalent employees): September 2017
  • All other businesses: September 2016

The FDA’s Preventive Controls Rules apply to all facilities required to register with the FDA as a food facility, unless covered by an exemption (See page 19 of the final rule for a complete list of exemptions). A covered facility must implement a written Food Safety Plan that identifies known or reasonably foreseeable biological, chemical, and physical hazards related to foods in the facility. For each identified hazard, the Food Safety Plan must determine whether the hazard requires preventive controls and, if so, outline preventive controls to minimize or prevent that hazard.

While similar to other food safety programs, such as HACCP, ISO 22000, or BRC, these plans do not satisfy the requirement of having an FDA Food Safety Plan. A Preventive Controls Qualified Individual (QI) must create or oversee the development of a facility’s Food Safety Plan. The Preventive Controls Qualified Individual may or may not be an employee of the facility.

The Preventive Controls Rules also require covered facilities to approve their raw material and ingredient suppliers when the receiving facility has identified a hazard requiring a preventive control. In approving suppliers, facilities must consider multiple factors, including the supplier’s performance (i.e., compliance with FDA regulations, including FDA warning letters, Import Alerts, etc). Facilities can use the FDA’s public databases or a third-party tool to monitor a supplier’s status.

Produce Safety Rule

Proposed: January 2013
Finalized: November 2015
Compliance Dates: Compliance dates for the FDA’s Produce Safety rule depend on a business’s size, exemption status, and whether or not the business deals with sprouts. Click here for more information on Produce Safety compliance dates.

The FDA’s Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. The rule puts more responsibility on farms to protect their crops from contamination by creating requirements for water quality testing, raw manure application, examining grazing areas, employee health and hygiene training, and more. The rule gives special attention to sprouts due to their frequent association with foodborne illness outbreaks.

Foreign Supplier Verification Program (FSVP) Rule

Proposed: July 2013
Finalized: November 2015
Compliance Dates:

The latest of the following dates:

  • 18 Months after publication of the final rule  (May 2017)
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules: six months after the foreign supplier is required to meet the relevant regulations.
  • For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations: the date by which it has to comply with those provisions.

The FSVP rule requires importers to verify their foreign suppliers are producing food in compliance with applicable FDA regulatory requirements. To approve a supplier, an importer must evaluate the risks posed by foods it supplies by determining potential hazards associated with each food, as well as by evaluating the supplier’s performance (i.e., FDA compliance history). Importers must then implement an FSVP for each approved supplier and each food imported from that supplier. The rule gives importers the flexibility to choose appropriate verification activities for each food and supplier. Examples of potential verification activities include annual onsite audits of a supplier’s facility, sampling and testing a supplier’s products, or reviewing a supplier’s food safety records.

The FDA defines an importer as “the U.S. owner or consignee of a food offered for import into the United States” for purposes of this rule. If there is no U.S. owner or consignee, the FDA considers the U.S. agency or representative of the foreign owner of consignee at the time of entry to be the importer.

Accredited Third-Party Certification

Proposed: July 2013
Finalized: November 2015
Compliance Dates: N/A (Voluntary)

The Third-Party Certification rule established a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications of foreign facilities and the foods they produce. Under the program, the FDA recognizes what are called accreditation bodies, which then may accredit third-party certification bodies.

Accredited third-party certification bodies can perform two types of audits: consultative and regulatory. A consultative audit is conducted in preparation for a regulatory audit, while a regulatory audit is the basis for certification. Foreign facilities can use certification from a Third-Party Certification Body for two purposes: participation in the FDA’s Voluntary Qualified Importer Program (VQIP) or to satisfy a request by the FDA that a food exported to the U.S. be accompanied by this certification (a request that may be made if the FDA suspects a food has the potential to be harmful to U.S. consumers). When a certification body conducts a regulatory audit, it must provide the FDA with a full report on the results of its inspection. The results of a consultative audit may remain private, but a certification body is required to report to the FDA if a consultative audit reveals issues that may pose a serious risk to consumer health.

Sanitary Transportation Rule

Proposed: February 2014
Finalized: April 2016
Compliance Dates:

  • Small Businesses (businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts): April 2018
  • All other businesses: April 2017

The Sanitary Transportation rule created new requirements for shippers, receivers, loaders, and carriers that transport food in the U.S. by motor or rail vehicle to ensure food is protected during transportation, via both the design and maintenance of transportation vehicles and equipment and by taking appropriate measures to ensure food safety by maintaining proper temperature controls and protecting food from contamination. Shippers, loaders, carriers, and receivers must develop written procedures detailing how they will ensure the safe transportation of food according to their specific requirements under the rule. The Sanitary Transportation rule applies whether or not the food is offered for or enters interstate commerce.

Intentional Adulteration Rule

Proposed: December 2013
Finalized: May 2016
Compliance Dates:

  • Very-small businesses (a business [including any subsidiaries and affiliates] averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale [e.g., held for a fee].): May 2021
  • Small Businesses (a business employing fewer than 500 persons): May 2020
  • All other businesses: May 2019

As with the FDA’s Preventive Controls Rules, the  Intentional Adulteration Rule applies to all facilities required to register with the FDA as a food facility, unless covered by an exemption (see section titled “Exemptions”). The rule requires facilities to develop and implement a written Food Defense Plan that assesses vulnerabilities within the facility, identifies a mitigation strategy for each vulnerability, and identifies monitoring procedures to ensure effectiveness of the mitigation strategies. A QI must prepare a facility’s Food Defense Plan.

Complying with FSMA

Registrar Corp’s FSMA Wizard is a free tool that helps you determine your possible requirements under FDA’s Food Safety Modernization Act (FSMA).

Registrar Corp’s Regulatory Specialists can assist with new requirements under FSMA, including developing or reviewing Food Safety Plans and Food Defense Plans.  Registrar Corp’s FDA Compliance Monitor allows users to monitor their suppliers for FDA Import Alerts and Warning Letters, as required under FDA’s Preventive Controls Rules and FSVP Rule.

This article was originally published in Food Online.

         

On July 14, 2016, the U.S. Food and Drug Administration published a final rule to amend the registration of domestic and foreign food facilities. Part of FDA’s Food Safety Modernization Act (FSMA), the rule is intended to improve the accuracy of FDA’s registration database and improve efficiency with regard to FDA’s use of inspection resources.

The final rule codifies some of the self-implementing regulations that became effective upon the enactment of FSMA.  These include:

  • E-Mail Addresses: Domestic facilities must list an e-mail address for the contact person at the facility. Foreign facilities must list an e-mail address for their U.S. Agent for FDA communications.
  • Inspections: All registrations must contain assurance that FDA will be permitted to inspect the registered facility.
  • Registration Renewal: Food facilities must renew their FDA registrations between October 1 and December 31 of every even numbered year. FDA offers an abbreviated renewal process for facilities that have no information to update from their previous registration.  FDA will consider non-renewed registrations to be expired.
  • Registration Suspension: FDA may suspend a food facility registration if the agency has reasonable belief that food manufactured, processed, packed, or stored at the facility may cause serious adverse health consequences or death to humans or animals.

The final rule also mandates new amendments to update FDA food facility registration:

  • US. Agents: A facility’s designated U.S. Agent will be able to view information submitted in the facility’s FDA registration.
  • Third-Party Submitters: Food facilities may authorize a third-party individual to complete their FDA registration on their behalf. Under the final rule, an individual submitting a food facility registration that is not the owner, operator, or agent in charge of that facility must identify the name, address, and phone number of the individual who authorized the third-party submitter to submit the registration.  The submitter must also identify himself in the registration.  FDA will not confirm a registration until the owner, operator, or agent in charge of the facility confirms with FDA that it has authorized the third-party submitter to manage the facility’s registration.
  • Product Categories and Activities: The Agency plans to add four new food product categories and revised three existing food product categories for animal food.  FDA will update the Food Product Categories Guidance if it makes changes to those for human food. Facilities must now identify the type of activity conducted at the facility for each food product category identified.  FDA plans to update the Types of Activity categories in Form FDA 3537, replacing the current “Acidified and Low Acid Canned Food Processor” category with separate categories for Acidified and Low Acid foods. Facilities that engage in holding or storing products must identify the type of storage provided at a facility (Ambient, Refrigerated or Frozen). FDA plans to add a new category for Farm Mixed-Type facilities that engage in both activities that are exempt from registration under section 415 of the Food, Drug and Cosmetics Act and activities that require the establishment to be registered. The agency plans to update Molluscan Shellfish to a Food Product Category instead of an Activity Type.
  • Electronic Registration: Beginning January 4, 2020, food facilities will be required to submit food facility registrations (including renewals, updates, and cancellations) electronically. A facility may request a waiver from FDA if it is unable to submit electronically.
  • Retail Food Establishment: The rule updates the definition of a retail food establishment to include (1) The sale of food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed; (2) the sale and distribution of such food through a community supported agriculture program; and (3) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.
  • Unique Facility Identifiers: FDA will require food facilities to list a Unique Facility Identifier (UFI) in their registration in order to verify the information provided in the registration. In the proposed rule, FDA specifically proposed to require Data Universal Numbering System (DUNS) numbers.  The agency did not finalize this requirement.  FDA will publish additional information regarding what UFIs will be recognized as acceptable for use in food facility registrations.  While DUNS numbers are not required, the final rule does state that FDA expects to recognize DUNS numbers as acceptable UFIs.  FDA expects to initiate the UFI requirement on October 1, 2020.
  • Registration Cancellations: FDA updated the circumstances under which the agency will cancel registrations. According to the final rule, FDA will cancel a registration if:
    • FDA independently verifies that the facility is no longer in business or has changed owners, and the owner, operator, or agent in charge of the facility fails to cancel the registration;
    • FDA determines that the registration is for a facility that does not exist, is not required to register, or where the information about the facility’s address was not updated in a timely manner in accordance with § 1.234(a);
    • The registration was submitted by an unauthorized individual;
    • The facility’s registration has expired due to failure to renew in accordance with § 1.230(b).

In addition to updating the reasons for cancellation, FDA also finalized the proposal to accept corrective action if it is submitted within 30 days of a cancellation confirmation. If circumstances meriting possible cancellation are corrected within 30 days after notice is provided, when appropriate, FDA will not cancel the registration.

It is prudent for food facilities to stay up-to-date on U.S. FDA registration requirements in order to avoid having their registration expired, suspended, or cancelled by FDA.  Marketing food from a facility with an expired, suspended, cancelled, or otherwise invalid FDA food facility registration in the United States is a prohibited act.  Food from a facility without a valid FDA registration may be stopped at the border when being imported into the United States.

Registrar Corp can quickly and properly register a facility with FDA as well as renew or update a facility’s registration as required by FDA.  Registrar Corp can also act as a foreign facility’s required U.S. Agent.  Registrar Corp’s U.S. Agent service provides numerous benefits, including:

  • Required registration updates and biennial registration renewal.
  • Three free Prior Notice filings each year
  • Detention and inspection assistance
  • Free FDA Compliance Monitoring
  • And more

For more information about FDA registration requirements or Registrar Corp’s services, contact 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) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).

Medical Device User Fees for FY 2017

  • Establishment Registration Fee: $3,382 (No Reduction for Small Businesses)
  • Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small Businesses
  • Premarket Notification (510(k)): $4,690 / $ 2,345 for Small Businesses
  • 513(g) request for classification information: $3,166 / $1,583 for Small Businesses
  • PMA Annual Report: $8,207 / $2,052 for Small Businesses

FDA’s FY 2017 medical device user fees show a decrease from FY 2016.

Registrar Corp can register medical device establishments with U.S. FDA as well as review a 510(k) for compliance with submission requirements.

Generic Drug User Fees for FY 2017

Application Fees:

  • Abbreviated New Drug Application (ANDA): $70,480
  • Prior Approval Supplement (PAS) to an ANDA: $35,240
  • Drug Master File (DMF): $51,140

Facility Fees:

  • Active Pharmaceutical Ingredient (API)—Domestic: $44,234
  • API—Foreign: $59,234
  • Finished Dosage Form (FDF)—Domestic: $258,646
  • FDF—Foreign: $273,646

FDA’s FY 2017 ANDA and PAS application fees show a decrease from FY 2016.   The FY 2017 DMF application fee as well as the API and FDF facility fees show an increase from FY 2016.

Registrar Corp can register a drug establishment and file DMFs with U.S. FDA.

         

On July 25, 2016, FDA regulatory compliance firm Registrar Corp launched the FSMA Compliance Wizard, a free tool to help food facilities, importers, and farms determine their possible requirements under FDA’s Food Safety Modernization Act (FSMA).  Enacted in 2011, FSMA is the most sweeping reform of the U.S. food safety system in over 70 years.  FSMA imposes broad new requirements on manufacturers, importers, processors, packers, and distributors of food, including requirements for supplier monitoring, the implementation of Food Safety Plans, and much more.

New requirements under FSMA involve many nuances depending on the size of a business, its functions, the types of food it handles, and even its location. Most FSMA rules offer modified requirements and a longer compliance period for small and very small businesses (terms defined differently in each rule). For instance, facilities that handle dietary supplements may be exempt from most requirements under the Preventive Controls Rule, but may still be subject to requirements under the Foreign Supplier Verification Program. Facilities in countries with food safety systems officially recognized by FDA may also be subject to modified requirements.

Registrar Corp urges each registered food facility to consider its exemption and modified exemption status carefully, as it may be more prudent to comply than seek a possible exemption. Registrar Corp’s FSMA Wizard is an excellent tool for any facility to begin the FSMA compliance process.

To use Registrar Corp’s FSMA Compliance Wizard, simply answer a series of questions regarding your facility, and the FSMA Wizard identifies specific requirements that may apply.  Possible requirements may be identified under the following FSMA rules:

  • FDA Preventive Controls for Human Food
  • FDA Preventive Controls for Animal Food
  • FDA Foreign Supplier Verification Program (FSVP)
  • FDA Produce Safety

Registrar Corp plans to add FDA’s Intentional Adulteration rule when the 2019 compliance date draws nearer.  Registrar Corp Regulatory Advisors are available 24-hours a day to answer any questions users may have throughout the process.

Visit http://www.fsmawizard.com/ to help determine your possible requirements under FDA’s Food Safety Modernization Act today.

This blog was originally published as a press release.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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