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Ten Steps to Comply with FDA UDI Requirements



July 30, 2015 by David Lennarz

The September 24, 2015 Unique Device Identifier (UDI) compliance date is quickly approaching. Life-supporting and life-sustaining device labelers, as well as most contact and intraocular lens labelers, have only two months left to comply with the U.S. Food and Drug Administration’s (FDA) UDI labeling and Global Unique Device Identification System (GUDID) requirements. Implantable device labelers must also obtain UDIs for their devices and enter information into the GUDID by this date.

To assist device labelers through the UDI compliance process, Registrar Corp compiled a list of the top ten things to do to comply with FDA’s UDI requirements.

1. Determine the UDI compliance date for each device

Compliance dates for FDA’s UDI requirements are spread out over the course of six years and depend on a device’s classification. For most devices, the compliance date for direct marking is different than for the other requirements. It’s important to keep up with FDA’s extensions, as some compliance dates have changed since FDA issued its final rule. Registrar Corp stays up to date on FDA’s UDI regulations and can help device labelers determine the compliance date for a particular device.

2. Obtain a DUNS number

All device labelers must obtain a Data Universal Numbering System (DUNS) number, as they are used to identify labeler organizations in GUDID. Labelers do not supply their name and address to the GUDID. This information is pulled from the DUNS database.

3. Obtain the GMDN term for devices

Device labelers are required to identify a Global Medical Device Nomenclature (GMDN) preferred term code for each device they submit to the GUDID. It’s prudent to identify a device’s GMDN code well before its compliance date, as it can take a substantial amount of time to obtain.

4. Calculate how many UDIs are needed

Each type of device and every version or model of each type of device will require a separate UDI. A different UDI is also needed for each size, color, material, style, and package size of a single device type. See an example here.

5. Obtain DIs from an FDA accredited issuing agency

Every UDI must contain a device identifier (DI). The DI portion of a UDI must be issued by an FDA accredited agency. There are currently three accredited issuing agencies to choose from: GS1 in New Jersey, HIBCC in Arizona, and ICCBBA in California.

6. Select a PI

UDIs for all devices, except class I devices, must contain a production identifier (PI). The labeler can choose one or more of the following to make up the PI portion of a UDI:

  •     The lot or batch number
  •     The serial number
  •     The expiration date
  •     The date manufactured
  •     The distinct identification code for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

7. Decide how to submit data to the GUDID

Data can either be submitted to the GUDID through FDA’s web interface, which allows one submission at a time, or through the Health Level 7 (HL7) option, which allows multiple submissions at once. Labelers must complete testing using a GUDID test account to be able to submit through HL7.

8. Create a GUDID account

Once a labeler has decided how they will submit data to the GUDID, they should create the appropriate GUDID account. FDA encourages those who choose to submit through the web interface to familiarize themselves with the system by creating draft submissions. Drafts are not visible to FDA.

9. Organize device information and submit data to the GUDID

Labelers will need to gather various information about each device to enter into the GUDID, including the description of the devices, their DIs, their brand names, their version or model numbers, their GMDN codes, their FDA listing numbers, and more.

10. Appoint a Regulatory Contact

Device companies must designate a Regulatory Contact for UDI and GUDID purposes. 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 products, and facilitate communication between FDA and the company.

Along with serving as a company’s Regulatory Contact, Registrar Corp can submit information to the GUDID on behalf of a device company. For questions regarding FDA’s UDI and GUDID regulations, contact Registrar Corp at +1-757-224-0177 or help is available 24-hours a day at http://www.registrarcorp.com/livehelp.

This blog was originally published as a press release.

         

On July 24, 2015, the U.S. Food and Drug Administration (FDA) issued a supplemental proposed rule that would require the percent daily value (%DV) for added sugars to be added to the Nutrition Facts label. sugar cubes The rule supplements two changes to the Nutrition Facts label proposed by FDA in March 2014, one of which proposed to include the amount of added sugars on the Nutrition Facts label, but not the %DV.  According to FDA, “the percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories.”

FDA’s supplemental proposed rule would also change the current footnote on the Nutrition Facts label to help consumers better understand the meaning of %DV.  The proposed statement reads: “The percent daily value (%DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”

FDA plans to finalize its rules regarding Nutrition Facts label regulations by March 2016.

FDA’s food labeling regulations are extensive and can be difficult to navigate.  Registrar Corp’s Label and Ingredient Review Specialists are well-versed on FDA’s requirements and can review food and beverage labels for FDA compliance.  Clients receive a detailed report with all FDA regulations applicable to their specific product and a print-ready graphic file that incorporates Registrar Corp’s suggested changes.

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

         

On July 16, 2015, the U.S. Food and Drug Administration (FDA) presented a seminar about basic Current Good Manufacturing Practice (cGMP) requirements for drug manufacturers as part of a two-day regulatory education event hosted in Silver Spring, Maryland, USA.   If a manufacturer does not follow FDA’s cGMPs, drugs manufactured at the facility may be considered adulterated.  Below are some of the key points regarding cGMPs discussed at the seminar.

1. Manufacturers should maintain detailed, written procedures and be sure to follow those procedures.

21 CFR 211.80(a) states:  “There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed.”   To support consistency, written procedures must be appropriate for the specific place of operation and its processes.  Failure to properly follow procedures is a common observation by FDA.

2. Manufacturers should ensure proper storage and identification of all products at their facilities.

Products should be stored in such a way that the manufacturer can inspect all aspects of the container and clean the area thoroughly.  For example, FDA raised questions about a box being stored on the ground.  If a leak occurred and the bottom of the box was soaked through, the manufacturer may not know until the box is later lifted and the contents are found to be contaminated or destroyed.

Manufacturers should also be sure to correctly identify and label materials as soon as they arrive at the facility.  Once an item is stored without being labeled, there is always the potential for misuse or accidental use, which could be disastrous.

3. Manufacturers should examine each lot of components, containers, and closures before use. 

FDA noted that due to liability and patient-safety issues, it is unacceptable for manufacturers to use untested materials in their production lines.  Bulk materials should be quarantined until they undergo appropriate testing to ensure they are ready for use.

4. Manufacturers should monitor and review their suppliers’ performance.

According to FDA, maintaining a reliable and secure supply chain does not start with a manufacturer’s finished product.  The manufacturer needs to understand its products’ components and know what its suppliers are doing.  Registrar Corp’s FDA Compliance Monitor can help drug manufacturers monitor their supply chains for FDA compliance issues.

5. Manufacturers should create policies for hazard prevention and avoidance.

FDA expects manufacturers to maintain reliable, efficient, and risk-mitigated operations and provide safe, effective, high-quality drug products.  In order to do this, manufacturers need to know where their risks are and be proactive in preventing and mitigating them.

FDA suggested that drug manufacturing companies task someone with consistently reviewing FDA’s current guidances and its updates to regulations.  Registrar Corp stays up-to-date on U.S. FDA regulations for drug manufacturers.  Follow Registrar Corp’s FDA News blog for regulatory updates. For questions about or assistance with FDA regulations for drug manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.

Click here to read about “What to Expect During a FDA Drug Manufacturer Inspection”, another FDA seminar presented during the regulatory education event.

         

On July 16, 2015, U.S. Food and Drug Administration (FDA) Facility Reviewer Denise DiGuilio presented a seminar titled “What to Expect During a FDA Drug Manufacturing Inspection.”  The seminar was part of a two-day regulatory education event held in Silver Spring, Maryland, USA.  During her presentation, DiGuilio discussed the various types of FDA Current Good Manufacturing Practice (CGMP) inspections, how FDA investigators prepare for an inspection, and finally, what to expect during an inspection.

Types of FDA Drug Manufacturer Inspections

There are four types of FDA CGMP Inspections:

  1. Pre-approval – FDA conducts pre-approval inspections before a New Drug Application (NDA) is approved to ensure the listed establishment is capable of manufacturing the drug and that data submitted in the NDA is accurate. FDA will likely request data to support that the processes listed in the NDA are feasible and will confirm whether the manufacturer has contamination and hazard prevention in place.
  2. Post-approval – FDA usually conducts post-approval inspections between 6 and 24 months after an NDA is approved. Post-approval inspections are used to monitor changes in production and control practices.  The extent of a post-approval inspection is determined by a manufacturer’s pre-approval inspection and compliance history.
  3. Surveillance/Routine – FDA conducts routine establishment inspections to ensure that drug manufacturers maintain compliance with CGMPs throughout their lifetime of operation.
  4. For-Cause/Directed – FDA conducts for-cause inspections to investigate specific problems brought to the agency’s attention.  For-cause inspections are typically the result of compliance issues, such as NDA field alert reports, recalls, a cluster of adverse events, etc.

FDA can choose to conduct a full or an abbreviated inspection.  During a full inspection, FDA will inspect a drug manufacturer’s quality system plus three other systems.  During an abbreviated inspection, FDA will inspect the quality system and only one other system.  FDA will always conduct a full inspection for a manufacturer’s initial inspection.   Other reasons FDA may choose to conduct a full inspection include a history of non-compliance, significant changes to the company (new management, new equipment, etc.), or as a follow up to a warning letter.

How FDA Investigators Prepare for an Inspection

Before an inspection, FDA investigators review:

DiGuilio strongly suggested that manufacturers familiarize themselves with these documents when preparing for an inspection, especially the IOM.  She said the documents will help manufacturers understand FDA’s expectations, guide them to relevant regulations, and help them interpret what the regulations mean.

What to Expect

The following steps are indicative of the typical flow of FDA drug manufacturer inspections:

  1.   FDA investigators are required by law to show credentials to the top management official of an establishment being inspected upon arrival.  Management may examine the credentials and record the number and name, but FDA credentials may not be photocopied.  Drug manufacturers located in the U.S. will also receive a Notice of Inspection upon FDA’s arrival.
  2. The lead investigator will state the purpose of the inspection and provide a general overview of the agenda.
  3. FDA investigators will tour the facility. They may ask if anything has changed since the manufacturer’s NDA was approved.
  4. After the tour, FDA investigators will look more critically at the establishment.  They will likely examine incoming raw materials, as well as review equipment logs and other records.  They may even question some employees about their daily work and watch as processes are executed. “Expect your investigators to stand there for an hour watching a sterile process,” DiGuilio said.
  5. DiGuilo suggested that manufacturers ask their investigators to participate in daily wrap up meetings so they can get an idea of how the inspection is going and what else may need to be inspected.  Manufacturers should ask if there is anything they can prepare for the investigator for the next day.
  6. At the end of the inspection, FDA may collect samples, issue an affidavit, or issue an Inspectional Observations Report (FDA Form 483).  At the end of a pre-approval inspection, FDA investigators will inform management of his or her initial recommendations before leaving.  FDA will not provide recommendations at the end of post-approval inspections.  Manufacturers can expect a copy of FDA’s inspection report within a month.

CGMP violations that FDA investigators typically look for include poorly trained employees, poorly maintained or contaminated equipment and facilities, lack of process controls, failure to conduct investigations or resolve CGMP issues and complaints, and more.  FDA will want proof of claims. If a manufacturer claims to be conducting routine maintenance, FDA will want to see documentation.  FDA will want scientific evidence to support conclusions made in various reports.

FDA generally classifies drug manufacturer inspections under one of three outcomes:

  1. Official Action Indicated (OAI) – This means FDA identified significant compliance issues during an inspection that require immediate corrective action.
  2. Voluntary Action Indicated (VAI) – This means FDA identified objectionable conditions or practices, but they do not warrant regulatory significance.
  3. No Action Indicated (NAI) – This means FDA did not identify objectionable conditions or practices.

It’s prudent for drug manufacturers to always be prepared for an FDA inspection.  FDA investigators’ inspection plans are influenced by previous FDA inspection reports and manufacturers’ past responses to 483s and warning letters. The better the outcomes of a manufacturer’s first few FDA inspections, the more likely the manufacturer will endure shorter and more lenient inspections in the future.

Registrar Corp is a consulting firm that helps drug establishments comply with U.S. FDA regulations.  Registrar Corp can help drug manufacturers:

For assistance with U.S. FDA regulations for drug manufacturers, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at http://www.registrarcorp.com/livehelp.

         

USA Cracks Down on Food Safety Compliance



July 16, 2015 by David Lennarz

During an interview with the Associated Press on July 13, 2015, U.S. Associate Attorney General Stuart Delery declared food safety compliance enforcement a priority of the U.S. Department of Justice.  “We have made a priority (of) holding individuals and companies responsible when they fail to live up to their obligations that they have to protect the safety of the food that all of us eat,” Delery said.

Companies that introduce adulterated food into U.S. commerce are subject to civil and criminal penalties under the Food, Drug, and Cosmetic Act (FD&C Act).  In recent years, cases where a food company was found guilty of distributing adulterated food products have resulted in various outcomes, from multimillion-dollar fines to jail time. The May 2015 ConAgra case is one example of the U.S. government’s crack down on food safety compliance.  ConAgra Foods agreed to pay $11.2 million dollars after pleading guilty to distributing peanut butter contaminated with salmonella.

Food safety lawyer Bill Marler said that the Department of Justice has criminally charged many companies that weren’t even aware they were shipping contaminated food.  This is yet another reason that food companies should take every possible precaution regarding food safety.  Registrar Corp offers various food safety services to help companies comply with U.S. food safety regulations.  Registrar Corp Regulatory Specialists can review a company’s HACCP or Food Safety Plan for compliance and can even conduct a Consultative Audit of a facility to help identify potential food safety issues. Registrar Corp’s FDA Compliance Monitor allows companies to monitor whether FDA has determined food safety issues regarding their own company or those in their supply chain.

If you have any questions regarding U.S. food safety regulations, contact Registrar Corp at +1-757-224-0177 or receive assistance 24-hours a day at www.registrarcorp.com/livehelp.

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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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