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New FDA API Reveals Annual Increase in Drug Recalls

August 20, 2014 by David Lennarz

On August 18, 2014, the U.S. Food and Drug Administration (FDA) announced on their official blog the release of a drug labeling application programming interface (API) on openFDA, an online database made available to the public in June 2014. The new API offers statistics regarding drug labeling and enforcement, like the number of drug label submissions each year and the breakdown of who reports adverse events.

In the context of the drug labeling API, an adverse event refers to when a person experiences an undesirable response associated with the use of a prescription or over-the-counter drug, such as a serious side effect or poor product quality. Those experiences can be submitted to FDA through an adverse event report. According to the new API, the number of annual adverse drug event reports has increased substantially in ten years. In January 2004, 12,978 adverse drug events were reported to FDA. In January 2013, the number of reports was 81,588. Not surprisingly then, the number of FDA monitored drug product recalls has risen substantially as well. In January 2014 there were 17 drug recalls. In January 2013 there were 383.

Labeling and manufacturing violations of FDA requirements account for 21% of drug product recalls. In the blog, FDA’s Chief Health Informatics Officer Taha A. Kass-Hout referred to approved drug labeling as a “living document” because, even after approval, labels need to be updated as new information about the safety and effectiveness of a drug unfolds.

“In some cases, the approved labeling for a prescription drug can be extensive, consisting of 20,000 words or more,” Kass-Hout said in the blog. “It can be a daunting task to study more than one labeling to better understand a class of drugs, or to compare drugs, and to keep up with their regular changes.”

Classifying a drug and ensuring a label contains all required elements can be difficult. Registrar Corp’s Labeling and Ingredient Review Service helps drug companies determine the likely classification of their products and helps ensure their drug labeling is in compliance with FDA requirements. For more information about FDA drug regulation, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists:

See the FDA blog here.


FDA Updates its Food Facility Registration System

August 19, 2014 by David Lennarz

On August 9, 2014 the FDA’s United Registration and Listing System (FURLS) Food Facility Registration Module (FFRM) underwent system maintenance.

FFRM users now have the ability to edit a food facility’s name and address in previously submitted registrations.

In the past, FDA’s food facility registration system did not permit modifications to a facility’s name or physical address after a food facility registration was submitted to the FFRM. This restriction prevented users from making corrections to typographical errors after submission.  Users had to cancel the registration and create a new registration (with a new registration number), even to make small changes.  Now, users are able to correct typographical errors without creating a new registration.  Users, however, must be very careful that they understand the FDA’s requirements regarding changes of ownership and/or physical address.  For example:

21 CFR 1.234(b) states:

“If the reason for the update is that the facility has a new owner, the former owner must cancel the facility’s registration as specified in 1.235 within 60 calendar days of the change and the new owner must re-register the facility as specified in 1.231. The former owner may authorize an individual to cancel a facility’s registration.”

When a company ceases operations at a facility location and begins operation at a different facility location, that company is the new owner of the new facility.  In order to comply with 21 CFR 1.234 (b), a change in a company’s physical address must be processed via a new registration.

FFRM includes a new feature to retrieve the PIN associated with a food facility registration number.

The new PIN retrieval feature in the main menu of the FFRM allows a user to retrieve a PIN by answering a series of five questions.  Previously, FDA did not have an online means to retrieve a lost PIN so this update should be helpful to many users.

FFRM now requires the e-mail address for food facilities and their U.S. Agents to be different. 

In addition to normal registration requirements, foreign food facilities must also designate a U.S. Agent for FDA communications.  The U.S. Agent serves a different function than an importer, customs broker, commercial distributor, or trade association.  FDA sends important communications to the U.S. Agent, including information regarding inspections.  U.S. Agents are expected to be available twenty-four hours a day, for FDA often requires an immediate response.

Along with FDA communications, the U.S. Agent is responsible for certain administered reinspection fees.  Beginning October 1, 2014, reinspection fees will be $217 USD an hour for domestic facilities and $305 USD an hour for foreign facilities.  These fees apply to all direct hours spent on the reinspection, including travel to and from the facility.  FDA often contacts a U.S. Agent via the e-mail address provided in a foreign facility’s FDA Registration.

The updated FFRM now prevents the registrant from proceeding with the registration if the e-mail addresses for the facility and the U.S. Agent are the same.  This update prevents registrants from circumventing the important role of the U.S. Agent by listing the facility’s e-mail address for both.  This e-mail update is especially important with the 2014 FDA registration renewal period approaching.  Food facilities are required to renew their registration between October 1st and December 31st of each even numbered year.  Any facility that currently lists the same e-mail address for both the facility and U.S. Agent will be required to change this before submitting their renewal.  When a facility changes their U.S. Agent information, the new agent is given 15 days to accept responsibility.  If they do not accept, the facility’s registration will become invalid and will need to be re-activated.

Registrar Corp acts as a U.S. agent for over 12,000 companies.  We can serve as a reliable, well-informed U.S. Agent for food facilities.  Along with communication services, Registrar Corp renews registration for clients and will even send a food safety expert trained in FDA inspections to facilities to help them prepare. If FDA gives notice of an inspection, Registrar Corp will perform the mock inspection for no additional cost other than travel and lodging expenses.

For questions regarding these changes and other FDA regulations, or to learn more about how Registrar Corp can assist your facility, contact us at 1-757-224-0177 or receive online Live Help from our regulatory specialists:


Registrar Corp Featured in Choose Hampton

August 19, 2014 by Maria Utecht

The City of Hampton, Virginia featured Registrar Corp as part of their Choose Hampton campaign. Take a couple minutes to check out the video and hear Registrar Corp Vice President and Co-Founder David Lennarz talk about the founding of the company.



FDA Prior Notice Timeline Requirements

August 15, 2014 by David Lennarz

All shipments entering the U.S. containing food, beverages, and dietary supplements are required to submit prior notice to the U.S. Food and Drug Administration (FDA). Prior notice may be submitted by anyone with knowledge of the shipment, including shippers, importers, U.S. Agents, and Customs brokers. Because the FDA uses prior notice submissions to best decide where their inspectors need to be, there are timelines in place for when prior notice must be submitted. Prior notice submitted through FDA’s Prior Notice System Interface (PNSI) may be submitted no more than 15 calendar days before the shipment is due to arrive. Prior notice submitted using the Automated Broker Interface/ Automated Commercial System (ABI/ACS) may be submitted no more than 30 calendar days before the shipment is due to arrive. For either submission method, prior notice must be submitted and confirmed by FDA no less than:

  • 2 hours prior to arrival for shipments arriving by road
  • 4 hours prior to arrival for shipments arriving by rail
  • 4 hours prior to arrival for shipments arriving by air
  • 8 hours prior to arrival for shipments arriving by water

For shipments arriving by international mail or express couriers, the prior notice should be submitted before the package is shipped. Failure to submit prior notice or filing late or inaccurate prior notice to FDA can result in issued warnings, monetary penalties, seizure of products, refusal, injunctions, and prosecution.

Registrar Corp can offer guidance to ensure your prior notice is properly filed. For help with prior notice or any other FDA regulations contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists:

About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations


FDA Changes to 510(k) and De Novo Submissions

August 15, 2014 by David Lennarz

On August 14, FDA issued a draft guidance regarding the evaluation of automatic class III designation, otherwise known as de novo classification. The guidance details a recent change in the requirements for submitting de novo classification request.  A new type of device is automatically classified as class III, regardless of its risk, if no similar device exists to guide FDA in classifying it. De novo classification refers to a process through which the manufacturer of a device that is automatically classified as class III can request that FDA reclassify the device as class I or II. According to the guidance document, such devices had to first be found “not substantially equivalent (NSE) to legally-marketed predicate devices through a premarket notification (510(k)).” Now, however, de novo classification requests may be submitted with or without a preceding 510(k).

Along with the change in submission requirements, FDA created a new public database for de novo requests. De novo submissions are now logged separately from 510(k) submissions. Also, FDA will now send most interim and final decisions about 510(k) and de novo submissions strictly through e-mail, so it’s more important than ever for applicants to include their e-mail address on their cover letters. FDA will also now accept a change in whom they contact regarding submissions via e-mail if the change is made before final decisions are rendered.

Most medical devices require a 510(k) to obtain clearance from FDA for commercial distribution in the U.S., though there are some exemptions. There is no form for a 510(k), but it does require a specific format and extremely detailed information about the submitted device. FDA even requires that proposed labels, product manuals, and advertisements be included with the paperwork. It’s common for a 510(k) to contain over a hundred pages. Registrar Corp offers a 510(k) Administrative Review and Submission Service to help companies avoid incomplete submissions and costly delays. The service includes verification of the structure, format, and required elements of a 510(k), and a review of the labels and guides to be included with the 510(k) submission. Registrar Corp will even submit the 510(k) to the FDA and facilitate the user fee payment.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. For assistance with 510(k) and de novo submissions, contact Registrar Corp at 1-757-224-0177 or receive online Live Help 24 hours a day from our regulatory specialists:

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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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