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.
The U.S. Food and Drug Administration (FDA) recently released its inspectional observation data for fiscal year (FY) 2017. The data presents an overview of violations cited by FDA during routine food facility inspections from October 2016 through September 2017. FDA consulting firm Registrar Corp compiled the most commonly cited food safety violations:
- Lack of Effective Pest Exclusion/Screening – The facility does not take effective measures to protect food against contamination from pests or exclude pests from food production areas.
- Sanitation Monitoring – The facility does not monitor sanitation conditions and practices frequently enough to conform to current good manufacturing practices (CGMPs). Some factors that should be monitored include the safety of water coming into contact with food and food contact surfaces, the condition and cleanliness of food contact surfaces, and the measures used to prevent cross-contamination from unsanitary objects.
- Plant Cleanliness – The facility fails to maintain cleanliness of the premises, or the facility is not constructed in a way that allows for proper sanitation or maintenance of floors, walls, and ceilings.
- HACCP Plan Implementation – A facility manufacturing seafood or juice fails to implement procedures in its HACCP plan. These may include monitoring critical control points of food hazards, verifying the adequacy of the plan’s hazard control, or maintaining records as required by 21 CFR Part 123
- Reasonable Precautions – The facility does not take precautions to prevent production procedures from contaminating food. Reasonable precautions may include monitoring food processing time and temperature or monitoring manufacturing operations, such as freezing or heat processing.
The violations listed above are nearly identical to the most common violations cited in FY 2016 and FY 2015. Food facilities should use this pattern to anticipate what areas in their daily operations may require further review before a FDA inspection.
It is worth mentioning that the 2017 list is the first to include violations related to FDA’s Preventive Controls Rules and Foreign Supplier Verification Program (FSVP) Rule, both of which had compliance deadlines in 2017. Most food facilities are now required to have implemented HARPC food safety plans, and many importers are required to have FSVPs. Despite the first FSVP compliance deadline passing as recently as May 2017, failure to develop an FSVP was cited 108 times. With the next FSVP deadline landing in March 2018, it is probable that FSMA violations may make their way to the top next year.
Inspection violations can result in Warning Letters, placement on Import Alert, suspension of facility registration, and other enforcement actions. With proper preparation and guidance, these food safety issues can be corrected before FDA visits a facility. Registrar Corp’s Food Safety Specialists can conduct a mock FDA inspection of your facility to identify potential food safety violations. Our expert, onsite assistance can guide your facility with knowledge and tools to have a successful FDA inspection. For more information, visit our site 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 U.S. Food and Drug Administration (FDA) recently issued a draft guidance that outlines their interpretation of the term “refusal of inspection.” According to the guidance, FDA requires food facilities receiving notice of FDA inspection to confirm acceptance of the inspection within 24 hours. Failure to confirm within 24 hours may be deemed refusal of inspection, resulting in refusal of that facility’s future food shipments to the US. Further, any attempts to limit or condition the inspection in any way likewise may be deemed a refusal of inspection, with the same harsh consequences.
What are the Consequences of Being Deemed a Refusal?
Facilities that refuse inspection are placed under Import Alert 99-32, and their food articles face refusal of admission at the port of U.S. entry. In addition, their FDA registration may be suspended.
How Can I Prevent Being Deemed a Refusal?
The recent guidance amplifies the importance of understanding FDA’s expectations for the inspection process and having a reliable U.S. Agent as a guide. Before the inspection begins, the Agency may interpret actions such as not agreeing to an inspection start date or rescheduling an inspection without reasonable explanation as attempts to circumvent the inspection. Upon receiving a notice of inspection, a facility should work with their U.S. Agent to respond to FDA promptly and cooperatively.
During the inspection, a facility should maintain this cooperation with the FDA inspector. Any attempts to interfere with or delay the inspection, such as limiting the inspector’s observations to certain areas of the plant or omitting requested documents, may constitute refusal. Facilities should ensure that they accommodate the inspector’s requests and refrain from any actions that might limit a full observation of daily operations.
Our Facility Is Under Import Alert for Inspection Refusal. What Can We Do?
To seek removal from the Import Alert 99-32 Red List, a facility must petition for inspection by FDA. The guidance states that for some facilities, scheduling an inspection after an initial refusal may take at least one year. Given this, full cooperation with FDA inspection is imperative to avoid loss of profits from an avoidable Import Alert.
Proper guidance from a third party experienced in FDA regulations can prove invaluable to a facility facing inspection. Registrar Corp’s trained Regulatory Specialists are knowledgeable in FDA inspections and can conduct a Mock FDA Inspection of your facility. Our experts can help identify potential food safety issues to fix before an inspection and educate facility staff on FDA expectations. 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.
Registrar Corp can act as your U.S. Agent to help you promptly schedule inspection with FDA, as well as provide your facility a host of additional benefits, including biennial registration, detention assistance, and compliance monitoring.
The U.S. Food and Drug Administration (FDA) requires most U.S. importers of food and beverages to develop and implement Foreign Supplier Verification Programs (FSVPs). Covered importers must document their foreign suppliers’ FDA compliance, including whether or not each supplier is subject to a FDA Import Alert.
Under FSVP, importers must only import from suppliers whom they have evaluated and approved. FDA requires verification activities outlined in a FSVP to be decided by the level of supplier risk determined from this evaluation. An Import Alert increases the probability that the importer must conduct more comprehensive verification activities to ensure the safety of a supplier’s products, such as onsite audits or sampling. In some cases, the importer may be unable to approve a supplier because they are under Import Alert. For these reasons, suppliers not on alert receive a competitive advantage in the market.
The next FSVP deadline is March 19, 2018, which applies to U.S. importers whose suppliers have fewer than 500 full-time equivalent employees. Before the deadline, food facilities outside of the United States should ensure that they are not subject to an Import Alert that may cause their U.S. Importers to not approve them.
What is an Import Alert?
Products on Import Alert face detention without physical examination (DWPE) at the port of entry. FDA issues Import Alerts when patterns of non-compliance from a specific business or country give the Agency reasonable belief that future shipments may violate regulations.
For example, FDA sampled 16 shipments of dried peppers from ten different shippers in Mexico in 1988. FDA found excessive mold in 14 of those samples. This led to the publication of Import Alert #24-11, which subjects all shipments of dried peppers from Mexico to DWPE unless the shipper’s product is exempt. This is just one instance of over 240 active FDA Import Alerts.
How do I know if my products are on Import Alert?
FDA does not directly notify a facility that it is under Import Alert. Instead, the Agency maintains a public database of Import Alerts with records of which products from which facilities are subject to DWPE. However, determining if products are on Import Alert may require time-consuming searches through numerous alerts for any facilities a given business might have a stake in. Registrar Corp’s FDA Compliance Monitor is a simple alternative that allows businesses to track all of their facilities at once and receive a detailed report of any alerts their products may be under.
My Products are on Import Alert. How do I get them removed?
A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA. This is only a small component of a larger process involving other, potentially extensive requirements.
The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert. These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.
Many businesses can be intimidated by the extensive requirements of an Import Alert petition. These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time. Despite a solution to the problem, some businesses might have no idea how to begin a petition.
Registrar Corp’s Regulatory Specialists are experienced in developing Import Alert petitions and can help you draft and compile the necessary documentation for Import Alert exclusion. Additionally, importers and suppliers can try Registrar Corp’s FDA Compliance Monitor free for 60 days to see which of their facilities may be on alert. For assistance, call us at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
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
The U.S. Food and Drug Administration (FDA) recently proposed to revoke an authorized health claim regarding the relationship between soy protein and decreased risk of coronary heart disease (CHD). According to a statement from Dr. Susan Mayne, FDA drafted this proposal after observing inconsistencies in published scientific data surrounding the claim.
Why is FDA changing the status of this claim?
FDA authorizes a petitioned health claim by examining the “totality of scientific evidence” surrounding the relationship between a specified substance and a disease (e.g. fruits and vegetables and the reduced risk of certain cancers). Publically available data must demonstrate “significant scientific agreement” (SSA) among qualified experts for FDA to authorize the claim.
In the case of soy protein and CHD, Mayne states that “the totality of currently available scientific evidence calls into question the certainty of this relationship.” Studies conducted following the claim’s authorization in 1999 yielded inconsistent findings between the two and helped influence FDA’s decision to issue the proposed rule.
What does this mean for my food labeling?
Substance/disease relationships that do not meet the standard of SSA may become qualified health claims through petitions to FDA that provide credible scientific support. Such claims require a disclaimer or other qualifying language on a product’s labeling that convey the level of scientific support for the relationship. Examples of qualified health claims include:
- “Vitamin C may reduce the risk of colon cancer. The scientific evidence supporting this claim is persuasive, but not conclusive.”
- “Although the evidence is not conclusive, tomato products, which contain lycopene, may reduce the risk of prostate cancer.”
- “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”
Should FDA finalize this rule and a petition for the soy protein and CHD relationship provide sufficient scientific support, the Agency may consider it a qualified health claim. FDA issues Letters of Enforcement Discretion that outline specific language, similar to the examples above, for making qualified health claims on a product’s label. Food manufacturers who previously displayed the authorized claim may need to adjust their labeling to reflect potential changes.
While this proposed rule does not enact certain or immediate changes, food manufacturers should be conscious of health claims on their labeling, especially when updating to comply with FDA’s new label rules. Labels presenting claims that are not authorized or qualified are considered misbranded. Marketing a misbranded food product in the United States is a prohibited act that may be met with Warning Letters, detentions, or other enforcement actions.
An examination of your labeling by a third party experienced in FDA regulations can be an invaluable business decision. Registrar Corp’s Regulatory Specialists can conduct a full review of your product’s labeling. In addition to a detailed report of recommended revisions, you will receive a print-ready file of your revised label. For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
The small business compliance deadline for the U.S. Food and Drug Administration (FDA) Preventive Controls Rule for Human Food passed on September 18, 2017. Under the Foreign Supplier Verification Program (FSVP) Rule, many U.S. importers have six months from this deadline (until March 19, 2018) to implement FSVPs for foreign suppliers of human food that qualify as small businesses (defined as having fewer than 500 full-time equivalent employees).
FSVPs consist of documenting several detailed components for each foreign supplier and each category of their imported food products (i.e. chocolate confectionary, bottled oils, etc.) In order to ensure compliance before the deadline, Registrar Corp urges importers to begin creating their FSVPs now.
What do I need to develop FSVPs?
FDA requires the following, among other things, of importers covered by the March deadline.
Documentation of supplier compliance:
Importers are required to ensure that they import from suppliers whom they have evaluated and approved through various methods that outline the potential health risks their products pose. A covered importer must ensure that a supplier is compliant with preventive controls rules, including the implementation of a food safety plan, and allergen labeling rules. The importer must also monitor the supplier’s FDA compliance history.
Should an approved supplier be found non-compliant, FDA requires importers to take corrective actions. These may involve facilitating the development of the supplier’s Food Safety Plan or ceasing business with them until they become compliant.
Hazard analysis of food products:
The FSVP rule requires importers to document a detailed hazard analysis of each category of food products they import from a given supplier. The analysis should identify any known or reasonably foreseeable hazards that could pose illness or injury, as well as the potential risks involved in the supplier’s handling of the food during manufacturing procedures, storage, and transport.
The data obtained by this hazard analysis should be used to determine appropriate supplier verification activities relative to the level of risk these products pose, such as sampling or onsite audits of a food facility.
Why should I begin building my FSVPs now?
Developing the required documentation can be a lengthy process. A single supplier may need multiple FSVPs. Importers should make efforts to ensure they comply in time to be prepared for possible inspection. Registrar Corp saw evidence of FSVP inspections occurring within three months following the May 2017 FSVP compliance date.
Registrar Corp provides a variety of services to assist U.S. importers and their suppliers with requirements under the Food Safety Modernization Act (FSMA). Registrar Corp’s Food Safety Team consists of Qualified Individuals who are well-versed in the development of FSVPs and Food Safety Plans. Additionally, Registrar Corp’s FDA Compliance Monitor provides a simple solution to monitoring and approving suppliers as required under FSVP. Call us at +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.
Drug establishments registered with the U.S. Food and Drug Administration (FDA) are required to renew their registrations with every year between October 1 and December 31. The 2017 renewal period marks the first time that registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the year.
FDA requires drug establishments to report any changes to product listings in June and December each year. Until recently, unchanged listings required no action. This year, registrants must certify that all product listings which were not updated have had no changes occur to the data or labeling. Product listings that are neither updated within the year nor certified during the renewal period may be considered expired by FDA and removed from the Agency’s database. Marketing unlisted drugs in the United States is a prohibited act.
How can I obtain “blanket no change certification” for my drug product listings?
Registered drug establishments should submit a “Blanket No Change Notification” for all products that have not been updated during the current year to certify there were no changes to the data or labeling as part of their annual registration renewal. The notification must be submitted in structured product labeling (SPL) format. Structuring data in SPL format requires SPL authoring software. The SPL files can be submitted to FDA via the Agency’s Electronic Submission Gateway (ESG). Users may also use CDERDirect to submit for human drug listings. According to FDA, all SPL listing submissions will undergo a rigorous set of validation rules.
Registrar Corp can renew your FDA registration and certify or update your drug product listings using the required SPL format on your behalf. Our Regulatory Specialists are experienced in navigating FDA’s ESG and can complete your renewal quickly and properly. Contact us at +1-757-224-0177 or chat with a Regulatory Advisor online 24-hours a day at www.registrarcorp.com/livehelp.
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:
- 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.
- 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.
On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to the nutrition facts label for packaged food and beverages sold in the United States. The extension would provide large food businesses (defined for these rules as grossing ten million dollars or more in annual sales) until January 1, 2020 to comply, while small businesses would have an additional year.
The rules, finalized in May 2016, do not solely consist of formatting changes, but also includes updates to serving sizes, daily values, and nutrient definitions. Despite the compliance deadlines appearing distant, the required changes are not superficial and may be time-consuming to implement. Registrar Corp urges food manufacturers to make proactive efforts now to update their product labeling and ensure compliance.
Why should I start making these changes now?
FDA proposed extending the deadlines due to covered parties’ concerns over complying in time with the initial deadline of July 2018. They cited “issues regarding (among other things) the need for upgrades to labeling software, the need to obtain nutrition information from suppliers, the number of products that would need new labels, and a limited time for reformulation of products.” (Source)
Also of potential concern are the mandated updates to daily values for certain nutrients, such as dietary fiber, which will require many food manufacturers to readjust certain percent daily values on their labels. In addition, manufacturers will need to account for the daily values of vitamin D and potassium, which will be newly required on a product’s food label.
Many manufacturers will need to conduct laboratory tests for vitamin D, potassium, and other nutrients in their products. As the deadlines approach, laboratories may see a high volume of food manufacturers requesting nutrient testing, leading to potential difficulties in scheduling tests as laboratories near capacity. The cost of tests may also increase from high demand, and delays in obtaining results may occur.
Additionally, the daily value updates affect the eligibility for some food manufacturers to make claims associated with the nutrients on their labels. Nutrient content claims that state products are “high in” these nutrients or health claims that state products containing these nutrients “may reduce the risk of” certain diseases require the product in question to contain a specific percentage of the nutrient’s daily value consumed in one serving. In order to continue making these claims, some manufacturers may need to reformulate a product to match the required content of a certain nutrient.
For example, the new rules increase the daily reference value (DRV) of fiber from 25 to 28 grams. FDA requires a product to contain 20% or more of the DRV per reference amount customarily consumed (RACC) in order to claim it is “high in fiber”. A product with 5 grams of fiber per 25-gram RACC (20%) may claim to be “high in fiber” now, but once the new DRV of 28 grams takes effect, it will only contain about 18%. The product may need to be reformulated with more fiber or the claim will need to be removed from the product labeling by the deadline.
Food labeling consists of several components. The earlier you begin, the more time you allot for the unexpected and improve the chance of avoiding a surplus of outdated labeling inventory. If you do not want to navigate the changes on your own, Registrar Corp’s Regulatory Specialists are well-versed in FDA’s new food labeling rules and can transition your product labels for you. In addition to a report explaining all our changes, you will receive a print-ready file of your revised label. For assistance, simply complete the form below or call us at +1-757-224-0177.