regulatory complianceTHE PROBLEM

Many manufacturers, distributors, sales and service personnel of non-medical security and industrial x-ray systems are either unaware of their regulatory responsibilities or they just don’t have the expertise, staff or time to determine all the different requirements necessary to administer a regulatory compliance program.

Some “manufacturers” within the United States, and even more so, those manufacturers located outside the United States; often struggle to determine what their Federal and State regulatory registration and reporting obligations are.

Experience indicates that many manufacturers, distributors, sales and service personnel are also unaware of their regulatory registration and reporting obligations and especially those of their customer.

Some “manufacturers” within the United States, and even more so, those located outside the United States; often struggle to determine what their Federal and State regulatory registration and reporting obligations are. Experience indicates that many distributors of cabinet x-ray systems are also unaware of their regulatory registration and reporting obligations and those of their customer. (See STATE CABINET X-RAY MACHINE REGISTRATION REQUIREMENTS – OWNERS & INSTALLERS page).

As a result, there has been a negative trickle-down effect on the customer from the States and Provinces which has led to animosity towards both the distributor and the manufacturer. RCE Consulting can help YOU avoid this potential negative business impact. With an estimated global increase in the x-ray inspection market of 5-8% over the next 5 years, predominantly here in the United States, can you really afford to be non-compliant or place your valued customer in a non-compliant position with their State Radiation Control Agency?

Federal, State and Provincial regulatory requirements can be complex, difficult to find, change frequently and require the manufacturer, distributor, sales and service personnel to possess a working knowledge of each State or Province registration requirements, radiation protection program requirements, training requirements, dosimetry requirements, inspection and safety device testing and radiation leakage emission survey requirements. There are numerous differences in both State and Provincial requirements, including requirements for field service personnel as well.

WHAT MANUFACTURER’S, DISTRIBUTOR’S, SALES & SERVICE PERSONNEL NEED TO KNOW & WHAT RCE CONSULTING CAN DO FOR YOU?

FEDERAL REGULATIONS:

All radiation emitting devices are regulated by the US Food & Drug Administration (USFDA) or in Canada, it is Health Canada.

The FDA has published Performance Standards for some radiation emitting devices like cabinet x-ray equipment (21 CFR 1020.40) that the manufacturer must comply with in order to offer this equipment for commerce in the US. There are other devices that do not have a FDA Performance Standard (e.g., Bottle Fill Checkers).

Cabinet x-ray systems are subject to extensive requirements contained in US FDA Performance Standard 21 CFR 1020.40 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1020.40.

A Compliance Guide for Cabinet X-Ray Systems for Manufacturers of Cabinet X-Ray Products can also be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094358.htm#2

In Canada, the RED Act regulations contain 15 performance standards for different types of radiation emitting devices. In the RED regulations, http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._1370/index.html go to Schedule II, Part IV for Baggage X-Ray Equipment or Part XV for Cabinet X-Ray Equipment.

ALL Manufacturers AND distributors of “x-ray systems” sold in the United States must also comply with 21 CFR Parts 1000-1005 and 1010. See Table 1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1002.1 .

Manufacturers shall maintain records of the distribution to distributors/dealers in which the manufacturer distributes directly to dealers. Records received from dealers or distributors shall also be maintained pursuant to 21 CFR 1002.41.

STATE REGULATIONS:

All State Radiation Control Agency “registration” regulations for X-Ray Equipment require the “manufacturer” AND “distributor” who sells, leases, transfers, or lends radiation machines in any State, to notify the State’s Radiation Control Agency of the sale, installation, lease, rental, or demonstration within the required reporting timeframe. Each State has different reporting requirements and 7 States (AL, FL, MD, MI, NC, PA, SC) have specific reporting forms to submit. ALL States require the INSTALLER to report:

The names and addresses of persons who have received these machines; and

The manufacturer and model of each machine transferred, sold, leased, or lent; and

The date of transfer, sale, lease, or lending of each radiation machine.

Note: If a radiation-producing machine is brought into a State for “temporary use”, for example; a demonstration, trade show, or short term use for product reclaim, etc., the owner or person proposing to do so, or their authorized agent, shall give written notice to the State at least 2-5 working days before the machine enters the State. This is referred to as an “Out of State” provision or “Reciprocity” which almost every State has in their “REGISTRATION” regulations. Most States also limit the time the x-ray equipment can remain in the State for temporary use, while other States require machine registration even for temporary use.

There are 35 States that require your company to register if you intend to sell, lease, lend, rent, install, service and repair radiation emitting equipment.

There 13 States (AL, CO (Exam required), DE, MA, MN (Individual FSE Registration), NE, NH, NC (Sales & Service), OR, RI, SC, TN and UT) that require the Field Service Engineer to be registered specifically to perform his/her duties.

There are 7 States (AL, FL, MD, MI, NC, PA, SC) that require the Field Service Engineer to complete a specific installation form in addition to the State Vendor/Assembler required transfer/installation report.

In many of these States the machine owner is required to obtain evidence that the person engaged in these services is registered and if not, the owner is required to refuse the service until the manufacturer, distributor or servicing company is registered with the applicable State. This does NOT happen overnight.

If you sell, lease, rent, demonstrate, install or repair x-ray equipment, all of these requirements can get quite complicated. DON’T IGNORE THEM, WE CAN HELP!!!

RCE Consulting stays current and knowledgeable of ALL State requirements, Let US handle all this for YOU!!

RCE Consulting stays current with each States ever changing rules and we can help you. No other company we are aware of offers this complete service for “manufacturers” AND “distributors”.

THE SOLUTION

Recognizing the PROBLEM and the associated issues and challenges before you, RCE Consulting offers manufacturers AND their distributors a complete and comprehensive regulatory compliance service where ALL your specific regulatory registration and reporting needs are managed by RCE Consulting. We can also assist your customers in obtaining full regulatory compliance through our Radiological Compliance Services described on this web site on the ON-SITE TRAINING page or the ONLINE COURSES page. Please take a moment to review all the solutions and services RCE Consulting can provide to manufacturers and distributors.

HERE IS WHAT RCE CONSULTING CAN DO FOR YOU?

REGULATORY COMPLIANCE SERVICES INCLUDE:

FEDERAL COMPLIANCE SERVICES

Prepare and submit all required US FDA initial product reports, supplemental reports and annual reports.

Act as the “Manufacturers’ Designated United States Agent” for manufacturers exporting into the United States (e.g., China, Japan, South Korea, UK, Finland, Denmark, etc.) in accordance with FDA 21 CFR 1005.25 and respond to all FDA inquires as needed.

Prepare and submit additional FDA reports such as reports of product defects, responses to FDA Letters and prepare radiological incident reports as needed.

Obtain and maintain an active list of your companies FDA Accession Numbers for all radiation emitting products sold in the US. FDA Accession Numbers are often required for import permits when selling systems outside the US or at a moment’s notice when your equipment has been put on FDA or US Customs HOLD. This does happen.

STATE COMPLIANCE SERVICES

Prepare all State required Vendor/Assembler registration applications, submit updates and changes to the original registration application, prepare your annual renewal applications for each State you intend to provide sales and services which require this type of registration (35 States currently).

Prepare and submit all manufacturer AND distributor State required sales and installation reports for each State within the time frames required (Range from 10 days to 90 days).

Provide your manufacturing facility with a comprehensive written Radiation Protection Plan, work instructions, forms, NRC Regulatory Guides, State specific guidelines and all forms and training materials necessary for regulatory compliance within the State your manufacturing or distribution/testing facility is registered and located in the United States. State inspectors WILL visit your facility every 3-5 years.

RCE Consulting will schedule an annual visit to your site (Max. 3 days) and provide facility Radiation Safety Officer Training, sales and distributor training, x-ray operator training and/or Field Service Technician radiation safety training. Reasonable travel expenses billed separately.

Prepare and submit “Out of State” notifications when systems are transported into a State temporarily for lease, lending, reclaim, demonstrations or trade shows.

Maintain a copy of all individual manufacturer’s operator and field service maintenance course personnel training certificates, radiation safety training certificates and radiation meter calibration certificates. All of these documents are required for Vendor/Assembler registration and subsequent annual renewals therefore; these records must be readily available and current.

Provide routine quarterly reviews of all personnel dosimetry results and provide feedback as necessary.

For More Information About these Manufacturer or Distributor Compliance and Training Services, Please Contact Steve Norris at contact@rcexraytraining.com or contact me at Office 843-650-9724 or Mobile 865-696-9117.