Regulatory Approval

Overview of EU Medical Device Directive
The Medical Device Directive 93/42/EEC (MDD), at first glance, is filled with confusing rules, device classifications, and conformity requirements. In simple terms, the aim of the MDD is:

To define the essential requirements that medical devices must meet before being placed on the market
To establish conformity assessment procedures based on device classifications
To create tracking and reporting mechanisms available to national authorities to ensure and protect public health

In order to market your medical device within the member states of the European Union, your product must comply with the essential requirements of the MDD. Compliance with harmonized standards (such as EN 60601-1-2:2001 for EMC, and EN 60601-1 for electrical safety) can provide assumption of conformity to specific requirements.

As part of the MDD’s essential requirements (Annex I), you must also provide the following:

Technical Documentation (Technical File) – Technical documentation should contain full construction details and validation/verification data for your medical device. This will prove that you comply with the essential requirements of the MDD.

Risk Assessment – Your product’s risk assessment must include a construction evaluation, materials used, bio-compatibility analysis, infection and cross-infection risks, and potential risks during use. The resulting documentation becomes part of the Technical File.

Quality System – Your organization must meet the quality system requirements of the MDD. Conformity to ISO 13485, which is a harmonized standard in the EU, is a way to demonstrate conformity to the quality system requirements of the MDD for those annexes applicable.

Depending on your product classification, you may also need Notified Body approval. Within the Intertek Group, there are three European Union based Notified Bodies to the MDD:

Intertek Testing & Certification, UK, N/B No: 0359
Intertek Semko, Sweden, N/B No: 0413
Intertek ACSL, UK, N/B No: 0473

Once you have met all applicable requirements, it is your responsibility to show conformity with the Medical Device Directive by affixing the CE Mark to your device. CE marking for medical devices

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FDA Device Approvals and Clearances

Welcome to FDA’s information about medical device approvals. The following information is available:
New Device Approvals that include some of the newest medical technology available.
Monthly listings of Premarket Notification [510(k)] and Premarket Approval (PMA) decisions
Information on Humanitarian Device Exemption (HDE) approvals
Searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device.
Frequently asked questions about recently approved devices.

Databases
CDRH maintains searchable databases on its website containing 510(k) and PMA information
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from 510(k) requirements.

Monthly listing of 510(k)s
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.
Monthly listing of PMAs
Regulation also provides for the submission of a humanitarian device exemption (HDE) application. A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. The (HDE) application is similar in both form and content to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of a PMA.
CDRH also has available a number of other databases relating to medical devices and radiation-emitting products. Information not contained in the CDRH databases must be requested via a Freedom of Information request.

CiTech FDA Medical Device Testing

  • Marketing wants independent comparative testing
  • We need performance testing now for our 510(k)
  • We don’t have an environmental chamber
  • We’re not sure what testing FDA expects
  • We don’t have the specialized test equipment

If any of these look familiar, get help from CITECH, the leading independent test house serving the medical device industry exclusively. We know medical devices and what users and regulators expect of them. Our staff has decades of experience in safety and performance testing of products ranging from luer fittings to patient monitoring systems. We are equipped for electrical, electronic, mechanical, physical, and environmental testing. We can test against national and international standards . . . or we can develop special medical device testing methodology for you.

CITECH tests against ANSI, AAMI, IEC, ISO and EN standards for safety and performance for a broad range of medical devices, ranging from hypodermic needles to complex monitoring systems. This testing can help in the product development process, to support 510(k) submissions, or to justify the CE Mark. Comparative testing by an independent laboratory can also help you demonstrate your device’s superiority over its competitors.

We recognize that the test methods in standards aren’t always appropriate … or, there may be no standards for your device. One of CITECH’s unique skills is understanding how medical devices are used and developing test methods that reflect this usage.

FDA 510k Reviews

Third-party review can slash months off the total 510(k) clearance (approval) time. With faster reviews, product launch dates become more predictable. Third-party review could make the difference between introducing your new product at the annual professional meeting and having to wait until months later. Third-party review is also friendlier, less adversarial, than FDA review.

Because of staff overload, FDA sometimes takes many months to review a 510(k); this can result in lost sales. FDA has authorized a small number of outside organizations (called “Accredited Persons” or third parties) to serve as alternative primary reviewers of many 510(k)s. These third-party reviewers have shown that they can usually do the job faster than their FDA counterparts—our record is 22 days, including the final FDA decision time!

To take advantage of third party review, you prepare the 510(k) just as you would for direct FDA submission (Note: We are not permitted to help you prepare it). Then, instead of sending the 510(k) to FDA, you send it to an accredited third-party reviewer, such as CITECH. Our reviewer takes the place of the primary FDA reviewer, which is where most of the review time is typically lost. Once a contract is in place, our reviewer determines whether your 510(k) includes sufficient information to demonstrate Substantial Equivalence. Where this is not the case, we will ask you for additional information. When our review is complete, we rush the 510(k), along with our review report, to FDA for a final determination of Substantial Equivalence by the Branch Chief. This determination is usually made in 15 days or less.

Not all 510(k)s are eligible for third-party review. Any 510(k) that requires human clinical data to support Substantial Equivalence (except for NIBP devices) is ineligible. So are 510(k)s for life-support devices, life-sustaining devices, and implants. Except for these, nearly every other device that requires a 510(k) is eligible. If you’re not sure, we will help you determine whether your submission is eligible for CITECH review. No obligation.

Third-party reviewers receive no funds from the government, so we must cover our costs through fees that we charge the clients. CITECH provides no-obligation proposals for 510(k) reviews. These proposals include a fixed fee that is based on the size, complexity, and organization of the 510(k); we also provide a guaranteed turnaround time (typically several weeks) for our part of the review. Third-party reviews are exempt from the FDA review fee ($3,404 as of October 2007, $1,702 for small US companies). Thus, your real cost for CITECH review is our fee less the FDA fee.

Confidentiality? We know it’s a concern for you; it’s also a concern for us. FDA requires the same confidentiality from accredited third parties as it does from its own staff. Absolute confidentiality also makes good business sense for us. However, we are happy to a sign confidentiality agreement with you, if you prefer.

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