Medical Devices | FDA Registration | Saving Lives | www.itbhdg.com

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    LIMITED OFFER

    ■ Establishment Registration
    ■ Medical Devices Listing
    ■ U.S. Agent Service
    (Foreign Companies)
    ■ $350.00 USD | Initial Registration Fee

    * $300.00 USD | Annual Fee

    Simply ask for an invoice


    Government Fees are extra
    $4,884.00 USD | Annual Establishment Registration (FY 2019)
    $2,738.00 USD | Single payment | Could be exempt

  • Premarket Notification 510(k)
  • Premarket Approval (PMA)
  • Medical Establishment Registration


JUST YOU KNOW


Owners or operators of places of business (establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to renew their registration between October 1 and December 31, and list their products with the FDA, each year.


Medical devices that are also radiation-emitting products must comply with both medical device regulations as well as electronic product regulations.


Foreign establishments are required to provide the names of all known U.S. importers of their devices, and must continue to update this information whenever it changes.


The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. Agent.

The U.S. Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. Agent. The automated process will forward an email verification request to the U.S. Agent. The U.S. Agent will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. Agent denies consent (or does not respond within 10 business days), the Owner Operator of the foreign establishment will be notified and must designate a new U.S. Agent to satisfy the regulatory obligation.


As of September 30, 2016
24,584 domestic and foreign medical device establishments were registered with FDA.


A Medical Device regulated by the FDA under the Federal Food Drug & Cosmetic (FD&C) Act is defined as

■ an "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is :

■ recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

■ intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.



PREMARKET NOTIFICATION 510(k)


Premarket Notification, also known as FDA 510(k) for
companies that manufacture
Class II medical devices
and a small number of Class I devices.



WHAT'S INCLUDED?


■ U. S. Agent service (Foreign Companies).

■ Medical Device Establishment registration.

■ Medical Device listing.

■ Classification evaluation of your medical device and
determination of the proper FDA product code and regulation number.

■ Determination of which similar (predicate) devices
already have FDA 510(k) clearance and whether
they are suitable for use in your 510(k) submission.

■ Payment of FDA fees on your behalf (only if needed).

■ Filing of the 510(k) and follow-up with FDA reviewer.



Premarket Notification 510(k) | Premarket Approval (PMA) | Establishment Registration | www.itbhdg.com

REGISTER NOW



Administrative Review and Submission Service
do not include an evaluation of your science, data or technology.



REQUIRED INFORMATION


(*) Full company's name (as registered locally)
(*) Street address, city, postal / zip code, state, country
(*) Full name of CEO / Manager
(*) Telephone number of CEO / Manager
(*) Email of CEO / Manager
(*) Product details


SUBMIT COMPANY INFORMATION



REQUEST AN INVOICE




Payment methods accepted

PayPal, Local European Payments
Debit and Credit Cards
Electronic Invoice, Bank Wire






The Medical Device User Fee Amendments (MDUFA)


Small Business Qualification and Certification Request

To be eligible for a reduced small business fee for the first - PMA, PDP, PMR or BLA - your company must qualify as a “small business.”

This is defined as having gross receipts or sales of no more than $100 million for the most recent tax year.


For businesses headquartered outside the United States, your National Taxing Authority (the equivalent of the U.S. Internal Revenue Service), must complete an FDA form.


Any business, regardless of location, may apply to be certified as a small business.



The establishment registration fee is not eligible for a reduced small business fee.







Legislation

Class I/II Devices
Exempt from 510(k)
Class I Devices Exempt from
Good Manufacturing Practices (GMP)s


Devices exempt from 510(k)


preamendment devices not significantly changed or modified; or

Class I/II devices specifically exempted by regulation.



For purposes of 510(k) decision-making, the term "preamendment device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976 and which have not been :



significantly changed or modified since then; and

for which a regulation requiring a PMA application has not been published by FDA.



Devices meeting this description are referred to as "grandfathered" and do not require a 510(k).


[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2017]
[CITE: 21CFR890.5740]
 

 

Class I and Class II Exempt Devices

PART 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
PART 864 HEMATOLOGY AND PATHOLOGY DEVICES
PART 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
PART 868 ANESTHESIOLOGY DEVICES
PART 870 CARDIOVASCULAR DEVICES
PART 872 DENTAL DEVICES
PART 874 EAR, NOSE, AND THROAT DEVICES
PART 876 GASTROENTEROLOGY-UROLOGY DEVICES
PART 878 GENERAL AND PLASTIC SURGERY DEVICES
PART 880 GENERAL HOSPITAL AND PERSONAL USE DEVICES
PART 882 NEUROLOGICAL DEVICES
PART 884 OBSTETRICAL AND GYNECOLOGICAL DEVICES
PART 886 OPHTHALMIC DEVICES
PART 888 ORTHOPEDIC DEVICES
PART 890 PHYSICAL MEDICINE DEVICES
PART 892 RADIOLOGY DEVICES



Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the Food and Drug Administration (FDA).

However, several other FDA regulations apply:

■ U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA

■ Foreign manufacturers must register their establishment with FDA and name a United States Agent

■ Manufacturers must list their devices with FDA

■ Manufacturers must meet Quality System (QS) requirements

■ The lens for spectacles and/or sunglasses must be certified as impact resistant.

Any certificate submitted should show the lenses meet an AQL of 6.5 when tested by the drop ball test or an equal or superior test method.




Requirements for Class I/II Exempt Devices


Even though a 510(k) is not required, it is necessary to meet other requirements for marketing. These include:

■ Registration and Listing

■ Labeling

■ GMP's



Government Fees

All establishments that are required to register must now pay the annual registration user fee as required by Food and Drug Administration Safety and Innovation Act (FDASIA).


Payment must be made in U.S. currency

drawn on a U.S. bank by electronic check, check, bank draft, U.S. postal money order, credit card, or wire transfer.

The preferred payment method is
■ online using electronic check (Automated Clearing House - ACH also known as eCheck)
■ or credit card (Discover, VISA, MasterCard, American Express).

Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available.

Use the following account information when sending a payment by wire transfer:

U.S. Department of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045

Account Number: 75060099

Routing number: 021030004

SWIFT: FRNYUS33

Beneficiary:
FDA
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002

FDA's tax identification number is 53-0196965.




Establishment Registration Fee | Annual

FY19 Fees for Establishment Registration

The annual establishment registration fee must be paid between October 1, 2018, and December 31, 2018.

For FY19, the registration fee for each establishment is
$4,884 USD.

All establishments are required to pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.



Fiscal Year 2019
Fees $4,884



Medical Device Product Review Fee | Initial

The fee for medical device product review applies to
Premarket Approvals (PMAs),
Product Development Protocols (PDPs),
Biologics Licensing Applications (BLAs) (for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research),
certain supplements, and
Premarket Notification 510(k)s.

The fee must be paid for the above listed applications, unless the applicant is eligible for a waiver or exemption.

Fiscal Year 2019
Standard Fees - 510(k) $10,953 Reduced Fees - 510(k) $2,738

Small Business Fees (Waived for first premarket approval submission (PMA) from firms with gross receipts or sales ≤ $30 million).


For FY 2018 (October 1, 2018 through September 30, 2019), the fees for PMA applications are:

FY18 User Fees (in U.S. Dollars)

application type
standard fee
small business fee
510(k)‡
$10,953
$2,738
513(g)
$4,349
$2,175
PMA, PDP, PMR, BLA
$322,147
$80,537
Panel-track Supplement
$241,610
$60,403
180-day Supplement
$48,322
$12,081
Real-time Supplement
$22,550
$5,638
BLA Efficacy Supplement
$322,147
$80,537
PMA Annual Report
$11,275
$2,819
30-day Notice
$5,154
$2,577

† For small businesses with an approved SBD.

* PMA=Premarket Approval | PDP=Product Development Protocol | BLA=Biologics License Application | PMR=Premarket Report (for a reprocessed device).







Companies required to register their establishments and list their devices with the FDA


Firms that
■ manufacture
■ repackage and relabel
■ develop specifications
■ reprocess single-use devices
■ remanufacture
■ manufacture accessories and components sold directly to the end user.


Establishments located in foreign trade zones must register and list, as well as identify themselves as being located in a foreign trade zone.


All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.


Foreign Establishments

Required to pay FDA Fees

Register List Pay
Contract Manufacturer (including contract packagers) YES
YES
YES
Contract Sterilizer YES
YES
YES
Custom Device Manufacturers YES
YES
YES
Device Being Investigated under IDE NO
NO
NO
Foreign Exporter of devices located in a foreign country YES
YES
YES
Foreign Manufacturers (including Kit Assemblers) YES
YES
YES
Maintains complaint files as required under 21 CFR 820.198 YES YES YES
Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user YES
YES
YES
Manufacturer of components that are distributed only to a finished device manufacturer NO
NO NO
Relabeler or Repackager YES
YES
YES
Remanufacturer YES YES YES
Reprocessor of Single-use Device YES
YES
YES
Specification Developer YES YES YES


Personal Lubricants as Medical Devices

Device Lubricant, Personal
Regulation Description Condom.
Definition This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
Regulation Medical Specialty Obstetrics
Gynecology
Review Panel Obstetrics
Gynecology
Product Code NUC
Premarket Review

Office of Device Evaluation (ODE), Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD), Obstetrics and Gynecology Devices Branch (OGDB)

Submission Type 510(k)
Regulation Number 884.5300
Device Class 2
GMP Exempt? No
Recognized Consensus Standard

Premarket Notification 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device.

Substantial equivalence (SE)

means that the new device is at least as safe and effective as the predicate.

Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate."

A device is substantially equivalent if, in comparison to a predicate it:

■ has the same intended use as the predicate, and

■ has the same technological characteristics as the predicate

or

■ has the same intended use as the predicate, and

■ has different technological characteristics and does not raise different questions of safety and effectiveness; and the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.

Substantial equivalence does not mean the new and predicate devices must be identical.

Substantial equivalence is established with respect to

■ intended use, design, energy used or delivered,

■ materials, chemical composition, manufacturing process,

■ performance, safety, effectiveness, labeling,

■ biocompatibility, standards, and other characteristics, as applicable.

When the device is manufactured under contract by another firm or entity, the specification developer submits the 510(k), not the contract manufacturer.

FDA does not perform 510(k) pre-clearance facility inspections. The manufacturer should be prepared for an FDA quality system inspection at any time after 510(k) clearance. The holder of a 510(k) must have design control documentation available for FDA review during a site inspection.



Misbranding by Reference to Establishment Registration Number


Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products.


Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.


Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA.



Banned from shipping Medical Devices to the U.S


Foreign inspections of device manufacturers are being performed and detention without physical examination (DWPE) may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMPs).


A total of 10 UK companies are now listed on the import alert list, along with companies in 26 other countries including Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Pakistan, Peru, Spain, Switzerland, Taiwan and Thailand.


Foreign manufacturers listed on the Red List of the import alert who would like to request removal from that list should provide information to FDA to adequately demonstrate that the manufacturer has resolved the conditions and/or practices that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

This may include a letter detailing corrective actions, accompanied by documentation.



INITIAL IMPORTER SERVICE


The initial importer of the device must register its establishment with FDA.

An initial importer is
any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user,
but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.


Wholesale distributors of medical devices, who do not manufacture, repackage, process, or relabel a device in the U.S.,
are not required to register their establishment with the FDA.

A "wholesale distributor" is defined as
any person (other than the manufacturer or the in initial importer) who distributes a device from the original place of manufacture
to the person who makes the final delivery or sale of the device to the ultimate consumer or user.


Importation of Electronic Products

Importers of radiation-emitting electronic products subject to an FDA performance standard are required to submit a

■ written declaration on "Declaration of Products Subject to Radiation Control Standards - FDA form 2877

■ other import entry information, through U.S. Customs Border Protection (CBP).



INNOVATIONS IN MEDICAL DEVICES


Guardtime AS (Estonia), industry partners Instant Access Medical Ltd (UK) and Healthcare Gateway Ltd (UK) have launched the world’s first comprehensive blockchain-supported Personal Care Record Platform, MyPCR.

MyPCR uses Healthcare Gateway’s Medical Interoperability Gateway (MIG) for instant access to primary care information, personal care pathways and smartphone medication support of 30 million National Health Service (NHS) patients in the United Kingdom.