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)
    * $750.00 USD | Initial Registration Fee

    * $400.00 USD | Annual Fee
    Government Fees are extra

INVOICE

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


JUST YOU KNOW


As of September 30, 2016
24,584 domestic (12,848) and foreign (11,736) 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.

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.

Completion of all 21 sections of the FDA 510(k) application.

Payment of FDA fees on your behalf.

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

Registration of your establishment with FDA.



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, 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.


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


Interested?






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).



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

CONTACT



Government Fees


* Establishment Registration Fee | Annual

* Medical Device Product Review Fee | Initial




The Annual Establishment Registration Fee : $4,624
Due between October 1 and December 31

There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.

Fiscal Year 2018
Fees $4,624


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 2018
Standard Fees - 510(k) $10,566 Reduced Fees - 510(k) $2,642

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


For FY 2018 (October 1, 2017 through September 30, 2018), the fees for PMA applications are:

FY18 User Fees (in U.S. Dollars)

application type
standard fee
small business fee
510(k)‡
$10,566
$2,642
513(g)
$4,195
$2,098
PMA, PDP, PMR, BLA
$310,764
$77,691
Panel-track Supplement
$233,073
$58,268
180-day Supplement
$46,615
$11,654
Real-time Supplement
$21,753
$5,438
BLA Efficacy Supplement
$310,764
$77,691
PMA Annual Report
$10,877
$2,719
30-day Notice
$4,972
$2,486

† 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).

ANY QUESTION?



United States Agent for Foreign Establishments


All foreign establishments must notify FDA of the name, address, phone, and email address of their United States agent.

Even if an establishment manufactures various medical devices, drugs, and/or biological products, each establishment can identify only one United States agent.


Responsibilities of the United States Agent

* Assisting FDA in communications with the foreign establishment
* Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and
* Assisting FDA in scheduling inspections of the foreign establishment.


The U.S. Agent has no responsibility to report adverse events under the Medical Device Reporting regulation.



FDA COMPLIANCE


Exporters and Importers must be registered with the Food and Drug Administration (FDA). The FDA Registration Number is used to process customs documentation and Prior Notice (PN) to FDA.

All shipments without FDA Registration Number and Prior Notice Confirmation Number, will be DENIED ENTRY by the U. S. Customs and Border Protection (CBP).


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.


Foreign Establishments

Required to pay FDA Fees

Activity Register List Products Pay Fee
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



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.


Interested in this service?


Please contact us at
T: +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
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