On June 2, 2017, the U.S. Food and Drug Administration issued a letter announcing that the Agency intends to extend the Unique Device Identification (UDI) compliance dates for class I and unclassified devices (excluding implantable, life-supporting or life-sustaining devices) to September 24, 2020 (two years after the original compliance date). FDA plans to solidify this extension with a guidance document regarding its enforcement discretion, but the Agency wanted to inform industry of its decision as early as possible.
Device labelers are responsible for implementing FDA’s UDI requirements. According to the letter, many labelers asked FDA for an extension upon realizing the substantial amount of time the process takes. The letter also notes that “providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices,” which leads us to believe many labelers are having difficulty completing the process on their own.
With this in mind, it’s prudent for device labelers to begin preparing for the 2020 UDI compliance date as early as possible to ensure they meet the requirements on time. Registrar Corp’s Regulatory Specialists can help you navigate the UDI process, including obtaining a DUNS number, calculating how many UDIs you will need, and more. For assistance, simply complete the form below:
The U.S. Food and Drug Administration (FDA) recently removed from its database of active registrations all medical device establishments that did not register for 2017. Owners or operators of device establishments must register annually with FDA. In early February, the Agency warned industry that it would remove all establishments that had not registered for 2017 by February 23.
Devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States. Registrar Corp is urging medical device companies to confirm their establishments are listed in FDA’s database as registered for 2017 before continuing business as usual: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
The registration fee for fiscal year (FY) 2017 is $3,382. Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees. For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
On February 7, the U.S. Food and Drug Administration (FDA) e-mailed medical device establishments that did not complete their annual registration for 2017. According to the e-mail, establishments that do not register and pay the associated fees by February 23, 2017 will have their registration removed from FDA’s database of active registrations. Medical devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States.
The registration fee for the fiscal year (FY) 2017 is $3,382. Registrar Corp can help medical device establishments register with FDA and facilitate payment of the associated fees. For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.
Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines.
Here’s a compilation of the happenings for the drug and device industries in 2016.
- February 18: FDA removed 771 drug facilities from the registration database due to failure to complete their annual registration renewal for 2016.
- August 1: FDA published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017).
- September 8: FDA issued a UDI compliance extension for certain Class II devices.
- September 24, 2016: This marked the Unique Device Identifier (UDI) compliance date for Class II devices. Read here for tips on UDI compliance.
- October 20: FDA proposed to require label submissions for Class II and Class III home-use devices.
- December 21: FDA banned the use of powdered medical gloves due to the substantial risk of illness or injury to both patients and medical professionals.
In addition to the various FDA extensions, proposals, and final rules that were released over the last year, the Federal Trade Commission (FTC) issued new labeling disclaimers for homeopathic drugs.
Registrar Corp is looking forward to the new year and continuing developments in FDA regulation of the drug and device industries. For any questions about FDA drug and device 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 December 19, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule (21 CFR Parts 878, 880, and 895) banning powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. According to the rule, FDA banned these products due to the fact that they present a substantial risk of illness or injury that cannot be corrected by eliminating or altering product labeling. Adverse events related to powdered gloves include:
- Severe airway inflammation
- Hypersensitivity reactions
- Allergic reactions
- Lung inflammation
- Damage to post-surgical adhesions
- Respiratory allergic reactions
The final rule becomes effective on January 19, 2017. The ban applies to all powdered gloves currently in commercial distribution, those already sold to consumers, and gloves intended to be distributed in the future. All banned gloves must be removed from the market by the effective date.
FDA defines a medical device ban as “a total prohibition on the current and future sales, distribution, and manufacturing of a medical device.” (21 USC 360f) FDA may analyze a device’s risks and benefits in many ways, including, but not limited to, evaluating medical literature, meeting with experts, or comparing the device to its alternatives. Only one other medical device has been banned by FDA since June 1983.
Registrar Corp is an FDA consulting firm that assists medical device companies with FDA regulations. Registrar Corp can help companies determine whether or not their products are banned under this final rule and review product claims for FDA compliance. For assistance with FDA regulations for medical gloves or other devices, contact Registrar Corp at +1-757-224-0177 or through our 24-hour Live Help chat service: http://www.registrarcorp.com/livehelp
The U.S. Food and Drug Administration (FDA) recently sent a reminder to medical device establishments that had not yet registered for 2017. FDA requires establishments involved in the production or distribution of medical devices intended for use in the United States to register their establishments annually between October 1 and December 31. The registration fee for the fiscal year (FY) 2017 is $3,382, which is a decrease from the fee for FY 2016 of $3,845.
A majority of the establishments that must register with FDA must also list their devices and the activities performed on those devices. A list of who is required to register, list, and pay fees can be found here. It is a prohibited act to manufacture or distribute devices in the United States without a valid FDA registration. Therefore, it is prudent for any device establishments that plan to continue business in the U.S. in 2017 to renew their registration as soon as possible.
FDA has deemed certain establishments and devices are exempt from registering due to low risk to patients and the role they play in advancing digital health. The product codes of devices that meet the exemption requirements are:
- LMB – Device, Digital Image Storage, Radiological
- LMD – System, Digital Image Communications, Radiological
- NFF – Device, Storage, Images, Ophthalmic
- NFG – Device, Communications, Images, Ophthalmic
- OUG – Medical Device Data System
- NXQ – Daily Assist Devices
Establishments dealing with the devices listed above should not list these devices with FDA during their 2017 registration.
Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations. Registrar Corp can help device establishments determine their applicable FDA registration requirements as well as register establishments and list devices with FDA. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.
On October 14, 2016, the U.S. Food and Drug Administration (FDA) announced a proposed rule that would require device manufacturers to submit labels and package inserts to FDA electronically when listing Class II and Class III home-use devices. The rule would allow manufacturers to submit labels and package inserts for Class I or other excluded home-use devices voluntarily.
FDA defines a home-use device as “a medical device intended for users in any environment outside of a professional healthcare facility.” These devices are intended for use in homes and healthcare facilities where:
- A user is a patient (care recipient), caregiver, or family member that directly uses the device or provides assistance in using the device.
- A qualified healthcare professional is a licensed or non-licensed healthcare professional with proficient skill and experience with the use of the device so that they can aid or train care recipients and caregivers to use and maintain the device.
Some examples of class II home-use devices include powered wheelchairs as well as certain pregnancy test kits. Examples of class III home-use devices include implantable pacemakers and replaceable heart valves.
According to FDA, the proposed rule would “better allow manufacturers to provide such facilities with information that is more robust, up-to-date, and user-friendly.” Once finalized, FDA has plans to make the device labeling information public through an FDA-managed or partner website. If finalized, manufacturers of class II and class III home-use devices would have to begin submitting labeling information 90 days after the publication of the final rule.
FDA opened this proposed rule for comments on October 17, 2016 for a 90-day period. Interested parties may submit electronic comments at www.regulations.gov. Enter docket number FDA-2016-N-2491 in the search box. FDA will review all comments before the release of the final rule, expected January 17, 2017.
Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations for medical devices, including labeling requirements. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.
On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension to the Unique Device Identification (UDI) compliance deadline for certain class II devices. The original compliance date of September 26, 2016 for the UDI label and submission of data to the Global Unique Identification Database (GUDID) has been extended to September 24, 2018.
The extension to the UDI rule applies to the following class II devices and constituents of certain combination products:
- Collections of two or more different devices packaged together in which the devices in the package are not individually labeled
- Repackaged single use devices (This extension does not apply to implantable, life-supporting or life sustaining devices.)
- Combination products assigned to FDA’s Center for Drug Evaluation and Research (CDER) or FDA’s Center for Biologics Evaluation and Research (CBER) for premarket review
FDA extended the compliance deadline for collections of two or more different devices packaged together to allow the agency time to finalize their draft guidance document titled “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug Administration Staff.” The deadline for repackaged single use devices is extended only to single use devices that are not individually labeled with an UDI.
Other class II devices are still required to comply with FDA’s UDI rule by September 24, 2016. Click here for tips for meeting this month’s deadline.
The UDI rule created a system that aims to identify medical devices from their distribution to the supply chain point of use with patients. Registrar Corp put together a short video on FDA’s UDI requirements.
For assistance with FDA’s UDI requirements or determining your compliance date, contact Registrar Corp at +1-757-224-0177 or talk to a Regulatory Advisor at www.registrarcorp.com/livehelp 24 hours a day.
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
- Abbreviated New Drug Application (ANDA): $70,480
- Prior Approval Supplement (PAS) to an ANDA: $35,240
- Drug Master File (DMF): $51,140
- 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 June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal. The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA).
What is ACE?
Customs brokers and self-filing importers must file information with CBP and other agencies regarding products they import into the United States. CBP describes ACE as “the primary system through which the trade community will report imports and exports and the government will determine admissibility.” CBP and FDA, along with 46 other government agencies, have partnered to make ACE a single window for submitting all data required by the agencies. ACE will replace ACS, the current commercial database used to submit data through CPB to FDA.
June 15, 2016 is the date when ACE is to become the sole filing system for the following FDA entry types:
- 01 – Consumption – Free and Dutiable
- 03 – Consumption – Antidumping/Countervailing Duty
- 06 – Consumption – Foreign Trade Zone (FTZ)
- 11 – Informal – Free and Dutiable
- 23 – Temporary Importation Bond (TIB)
- 51 – Defense Contract Administration Service Region (DCASR)
- 52 – Government – Dutiable
While June 15 acts as the mandatory filing date for these FDA entry types, CBP is allowing a sort of learning period through July 23, 2016. Entries filed through ACS after June 15 will likely be allowed, but the consequences will be decided on a case-by-case basis. Users may receive a warning message. CBP may also follow up with ACS filers to see why they are not filing through ACE and to determine how CBP can assist in the transition to ACE. Come July 23, ACS will no longer be allowed as an alternate filing method.
Common Errors when Filing in ACE
During the webinar, FDA revealed some of the most common errors and causes for entry rejection made when filing entries through ACE.
- Filers must provide a valid prior notice confirmation number for food and beverage shipments. Filers should only include the confirmation number and not the other FDA data required to file prior notice. Many filers submit invalid prior notice confirmation numbers.
- Many filers fail to provide a valid FDA registration number. (Tip: FDA requires food facilities to renew their FDA registration between October 1 and December 31 of each even-numbered year. Registrations not renewed as required are considered expired by FDA.)
- Many entries are rejected for a missing or invalid product code, affirmation of compliance code, or intended use code.
- Many filers include mismatching entity IDs. For example, an entry for a processed food must list a manufacturer code (as opposed to a grower code) as the entity ID.
- Many filers include mismatching source type codes. Entries for imports from growers or consolidators must list a country of growth, while entries for imports from manufacturers of processed foods must list a country ofproduction. Both types of entries must also include a country of shipment.
- Many filers list a foreign country as the ultimate consignee for non-food items. This is incorrect, as the ultimate consignee is meant to represent the final destination where the product will be delivered within the United States.
These are but a few of the mistakes made when filing entries within ACE. FDA offers assistance with ACE entries at[email protected]. FDA ACE support will be available 24/7 beginning sometime this month. FDA also provides this chart for identifying required data elements for entries of FDA-regualated products.
If you notice a mistake in an ACE entry, you may submit corrections up to 5 days before a shipment’s expected arrival to the United States. Once the shipment is within 5 days of its expected arrival, no corrections may be made unless FDA rejects the entry.
Speeding Up Your Imports
It’s prudent for brokers and importers to begin filing their entries through ACE as early as possible, as ACE provides the quickest entry. According to FDA, the agency is actively prioritizing ACE entries over those filed through ACS. Entries filed through ACE are processed two times faster.
While DUNS and FEI numbers are not currently required for filing entries of most commodities in ACE, FDA noted that including this data may expedite the processing of an entry. “Providing a DUNS number gives FDA a higher confidence level in looking at that data,” the agency said during the webinar regarding confirming the name and address of a product manufacturer.
How Registrar Corp can Assist
Registrar Corp offers a variety of services to help brokers obtain the information they need to file entries in ACE. Registrar Corp can:
Registrar Corp’s FDA Compliance Monitor also acts as a valuable resource for custom brokers and importers. The monitor provides detailed information on monitor facilities, such as a facility’s DUNS number (when available) and any FDA Warning Letters, Import Alerts, Import Refusals, and Inspection Classifications tied to the facility.
For more information on filing FDA-regulated entries in ACE, regulations for importing FDA-regulated products to the United States, or how Registrar Corp can assist, contact +1-757-224-0177. Live help is available 24-hours a day at www.registrarcorp.com/livehelp.