US FDA

Compliance with US FDA regulations is the surest way to dramatically increase the value of your products and to expand to the global market.

However, the FDA can also cause serious financial consequences as well as irrevocable damages on the corporate image if not complied within a timely manner. Particularly the last year's imports alone, the FDA had refused more than 15,500 products from abroad, and this strict screening process is expected to continue.

QVC through our alliance partners assists medical device manufacturers seeking Food and Drug Administration (FDA) approval to sell their products in the United States. One of the first steps for medical device companies who manufacture Class 2 medical devices (and a small number of Class 1 and 3 devices) is to file a Premarket Notification, also known as a FDA 510(k) submission, with the Food and Drug Administration. Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the US; they give "clearance" for them to be sold. To be cleared for sale by the FDA, the first step is to identify a Predicate Device(s), which is a medical device already cleared by the FDA and is similar to the one for which FDA approval is being sought.

In general, manufacturers introducing Class 2 medical devices to the US must submit a 510(k) to the FDA. A 510(k) is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect its safety or effectiveness.

FDA Fee Structure For 2013 fiscal year

The fees for 2013 are as follows (small-business fees in parentheses):

PMAs:

$248,000 ($62,000)

Panel-track PMA supplements:

$186,000 ($46,500)

180-day supplements:

$37,200 ($9,300)

Real-time supplements:

$17,360 ($4,340)

510(k):

$4,960 ($2,480)

30-day notice:

$3,968 ($1,984)

Request for classification:

$3,348 ($1,674)

PMA annual report:

$8,680 ($2,170)

Annual establishment registration fee:

$2,575 ($2,575)


What we do

QVC helps Medical devices and IVD manufacturers with all regulatory consulting issues for US-FDA. We provide services for following:

Quality System Compliance

  • Consulting for Quality system regulation (21 CFR 820) for medical device manufacturing
  • Assisting in Form 483 and warning letter analysis and response
  • Providing training for GMP (21 CFR 820)
  • Consulting in implementation of Quality system implementation
  • FDA GMP audits for 21 CFR 820 for medical device companies
  • Due diligence audits of medical device companies

Regulatory Consulting

  • Assisting in classification of medical device/IVD
  • Submission for FDA medical device (510K)/ PMA
  • FDA 5139g) submission for obtaining a classification ruling
  • Assisting in preparation of section of medical device submission
  • US-FDA establishment registration for medical for medical device companies
  • US FDA agent appointing for representation for the FDA

Determination of Substantial Equivalence 510K


Sections of 510K system

  1. FDA Medical Device User Fee Cover Sheet
  2. FDA Premarket Review Submission Cover Sheet
  3. FDA 510(k) Cover Letter
  4. FDA 510(k) Indications for Use Statement
  5. FDA 510(k) Summary or FDA 510(k) Statement
  6. FDA Truthful and Accuracy Statement
  7. FDA Class III Summary and Certification
  8. Financial Certification or Disclosure Statement
  9. Declarations of FDA Conformity and Summary Reports
  10. FDA 510 (k) Executive Summary
  11. Medical Device Description
  12. FDA 510(k) Substantial Equivalence Discussion
  13. Proposed Labeling
  14. Sterilization and Shelf Life
  15. Biocompatibility
  16. Software
  17. Electromagnetic Compatibility and Electrical Safety
  18. Performance Testing – Bench
  19. Performance Testing – Animal
  20. Performance Testing – Clinical
  21. Other

Three step device clearance

How are devices classified ?

  1. Class I General Controls
  2. Class II General Controls and Special Controls
  3. Class III General Controls and Premarket Approval

The Federal Food Drug & Cosmetic (FD&C) Act define medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) 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
(3) 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 its primary intended purposes.

How to obtain clearance in 3 steps

  1. Step 1:
    • Make sure the product that you wish to market is in fact a medical device
    • Determine the class of your device (I, II, or III)
  2. Step 2:
    • This classification will identify the marketing process: 510(k) or PMA
    • Develop data and/or information that is necessary to submit application
  3. Step3:
    • For some 510(k)s and most PMAs, clinical performance data is required; In these cases, a trial must be conducted in accordance with FDA’s investigational device exemption (IDE) regulation
    • Premarket Notification
      510K requires:
      Demonstration of Substantial Equivalence to Predicate Device(s) As safe and effective as the predicate device(s)
      Class I, II, Some class III

      Premarket Approval
      PMA requires:
      Demonstration of Reasonable Safety and
      Effectiveness
      Class III

* Device that are not subject to PMA; predicate devices: legally marketed before May 28, 1976 (preamendments device), or device that has been reclassified from class III to class II or I, or device that has been found SE to one of these devices through the 510(k) process.

US-FDA process flow chat and Role of US agent

Role of US FDA Agent

Any foreign medical device establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a U.S. FDA agent for that establishment. Information about a foreign establishment's US FDA agent is submitted electronically using the FURLS system and is part of the establishment registration process. Each foreign establishment may designate only one FDA agent. The foreign establishment may also designate its US FDA agent as its official correspondent. The US FDA agent has no responsibility to report adverse events under the Medical Device Reporting regulation.

The responsibilities of the US FDA agent are limited and include:

  • Assisting FDA in communications with the foreign establishment
  • Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the US
  • Assisting FDA in scheduling inspections of the foreign establishment
  • If FDA is unable to contact the foreign establishment directly, FDA may provide information or documents to the US FDA agent

If you wish to get US FDA Certification, please send us an enquiry.

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