Planning Early

BIOMATERIALS ASSESSMENT

Paladin Medical® guides you in the pre-selection of biomaterials with high potential for suitability in planning early for your medical device design. There are no “FDA-approved” biomaterials, however, materials can be selected with a higher potential for successful application in medical device design. Even when a material supplier provides an FDA Master File (MAF), the information must be presented as part of the comprehensive analysis within your Biological Risk Assessment. As described in LAUNCH, pre-clinical testing for biocompatibility according to FDA guidance documents and ISO 10993 standards can be difficult to avoid due to requirements to test the “final” device. Understanding qualification requirements early can play a major role in the cost-effective testing, and whether your test report will be accepted by the regulatory authorities. Despite the desire to have a universally standard biocompatibility system, there seems to be many barriers to acceptable biocompatibility testing acceptance. As part of your change control, we also help you manage the inevitable process or supplier change to select the optimum confirmatory evaluation. We will continue to be your Champion for your biomaterials qualification.
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Good Laboratory Practice 21 CFR Part 58

GLP compliance (21 CFR Part 58) is NOT a suggestion! According to the GLP preamble, safety studies must follow GLPs, but “functionality studies” are considered excluded. This has been the source of confusion since device manufacturers have often argued that testing an animal-version of a medical device constitutes a “functional” evaluation and is thus exempt. Unfortunately, the draft guidance of August 28, 2013, does nothing to clarify obligations. When device manufacturers evaluate a medical device for biocompatibility, bone in-growth or potential wear; particularly when histopathology is an outcome measure, FDA typically views these studies as first and foremost: safety. You could be in for a shock if preclinical studies are submitted to FDA without a statement of compliance to Good Laboratory Practices.

Paladin Medical® will assist you in developing scientifically sound preclinical protocols for your functional animal studies that result in data to support your submission. But if you have conducted a study where GLP compliance cannot be ascertained, we will help you with methods to augment GLP-compliance deficiencies. When a study is conducted in a non-GLP certified laboratory but has met the majority of the requirements, FDA has sometimes permitted a GLP-Compliance Statement. Paladin Medical can review the lab and study management and identify the level of compliance and produce a statement of compliance, informing FDA during the review of the study, what specific deficiencies may have occurred. We employ an itemized checklist and demonstrate section by section how the study quality and facility control systems were maintained. Post-study systems auditing can be useful to demonstrate the data should be considered valid. But perhaps before a study begins, consider Paladin Medical® services if you need an adjunct Quality Assurance Unit to augment large animal facility quality program and any time you need to conduct a pre-study audit for GLP compliance.
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Investigational Device Exemption (IDE) Regulations nd Applications

All studies of medical devices on human subjects are governed by Investigational Device Regulations. Clinical trials of an unapproved new medical device can be either Non-significant Risk (NSR) or Significant Risk and this determination is made not only on the type of device but also on the type of study you plan.

A significant risk study requires an IDE application and prior approval of the study and the basic safety of the device by FDA. A non-significant risk study does not require an IDE application but the device integrity at the time of the study must be under Design Control and Review quality regulations. Refer to Design Control and Review.

We help you to determine and document if your study may be non-significant risk. The determination must be supported by your Risk Analysis and Design Control and Review documentation. Beyond the IDE regulations, medical device manufacturers must also meet the requirements of the local human subject committee in each clinical or hospital (IRB). Prior to filing an IDE, if it is necessary, we will organize a Q-Submission to present your overall regulatory strategy and confirm your study plan will yield the evidentiary data required to move to the next appropriate premarket SUBMISSION.

Paladin Medical® offers assistance with:

• Design of clinical trials with clear objectives and outcomes supporting regulatory submissions
• Pre-qualification of investigators and study sites
• Informed consent forms, case reports and Investigator’s manuals
• Support and training of study sites
• Packaging and labeling that meet IDE regulations
• Product tracking to study sites and product use auditing
• Device retrieval safeguards and analysis
• Electronic data capture with internet access
• Sample size determination and statistical data analysis
• Compliance with IDE regulations and reporting requirements
• Clinical trial management and monitoring
• Clinical trial report development
• Sourcing investigators, laboratories, and testing services

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Customized Medical Device Training

Paladin Medical® will produce and deliver customized medical device training at a level suitable for your medical device and regulatory complexity. Start-ups often require quality system procedures training to ensure uniform understanding among the various new employees. Established firms may need training as the company moves into new areas of product control. Standards are always changing, and personnel move to new responsibilities. We help you keep up with these needs at appropriate times and at the scale that you need.
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Customization Products?

As medical devices become more complex you may find your product has been determined to be a COMBINATION PRODUCT, even without your intent. The basis for the determination of the whether a device may be a drug, a device or a combination product centers around some basic principles generally known as “mode of action”. A combination product may include a device and drug, a device and biologic or other “combinations”. FDA provides definitions of each of these categories, but it is possible a single constituent in a device can trigger concern by FDA that the device has more than one mode of action. The Office of Combination Products (OCP) develops cross-cutting FDA guidance for product classification, jurisdiction, and criteria for determining if a device could be a COMBINATION PRODUCT. Finding out after a submission has been made that the FDA considers your new product to be a COMBINATION can set back your track to market immeasurably. With our experience and expertise, we can help you to present your argument to FDA for the determination of jurisdiction and whether or not the device has some elements which might require review as a combination product. Frequently a combination product needs a “device” regulatory expert to navigate the CDRH (Center for Devices and Radiological Health) aspects with the regulatory consultants for the Center for Biological Evaluation and Research (CBER) or CDER (Center for Drug Evaluation and Research) components. We can do that.
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