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FDA Consensus Standards

Medical device regulatory laws continue to evolve not only with European Union changes to the 黄人导航 Regulation, but also with global harmonization efforts across the U.S. Food and Drug Administration (FDA). One of the more critical facets of global regulatory compliance involves FDA consensus standards and the conformity assessment procedure.

 

In general, the conformity assessment procedure is widely considered the validation of patient safety and medical device performance requirements. A primary goal of FDA new device approvals is to help ensure patients have access to reliable, high-quality products that increase efficacy.

 

What is FDA S-CAP?

 

According to the FDA鈥檚 webpage, the Standards and Conformity Assessment Program (S-CAP), promotes efficiencies and quality during the medical device regulatory review process by:

 

regulatory compliance consulting

  • Producing and implementing clear policies to promote the appropriate use of standards in regulatory processes
  • Anticipating the need for and leading the development of national and international consensus standards
  • Advancing initiatives to enhance confidence in conformity assessment activities
  • Fostering innovation and standardization in technologies that facilitate patient access to novel medical devices
  • Providing leadership in standards quality and utilization through outreach and global harmonization

 

Further, to fully understand the positive impact of S-CAP on the life sciences industry, this article will begin by reviewing four critical facets involved in the FDA听certified process: understanding FDA standards, the criteria for regulatory submission, defining a consensus standard, and medical device lab testing.

 

Understanding FDA Standards

 

The FDA Standards Recognition Program assesses the applicability of a standard鈥檚 safety and performance during a medical device鈥檚 regulatory review. Determining applicability often includes input provided from both technical and clinical experts within the FDA鈥檚 Center for Devices and Radiological Health (CDRH).

 

Standards Recognition Plan

 

A primary goal of the Standards Recognition Program is for FDA experts to collaborate as a team while evaluating existing standards. This helps S-CAP leaders make judgements to either formally or partially recognize a standard that can potentially become a widely accepted consensus standard. Further, this could play a role in FDA labeling as well.听

 

Conformity Declaration

 

Additionally, medical device manufacturers may also submit their own conformity declarations based on FDA-recognized consensus standards. For a premarket submission, using existing consensus standards already approved by the FDA can potentially help medtech manufacturers reduce the amount of supporting clinical data required for FDA marketing approval & fda approval process.

 

Criteria for Regulatory Submissions

 

The FDA鈥檚 Standards and Conformity Assessment Program also leverages pre-identified criteria designed to identify both vendors and manufacturers that voluntarily use FDA-recognized consensus principles. These standards, developed by FDA鈥檚 CDRH, can be a potential competitive advantage for FDA听medical device manufacturers.

 

Clinical Testing

 

Companies that use approved S-CAP vendors during new product development can potentially have their clinical testing burden reduced. Currently, this program is still gaining traction across the life science industry. The FDA approved list number of FDA听clinical trials approved vendors is slowly increasing.

 

Defining a Consensus Standard

 

The process of defining a consensus standard is not easy. They are often established (or accepted) by Standards Development Organizations (SDOs) that help distinguish what actual adherence means. Global adherence and acceptance are often based on the various attributes and reputation principles of the FDA consensus standards development organization, including:

 

  • Transparency
  • Openness to participation
  • Industry stakeholders
  • Balance of representation
  • Due process

 

Domestically, consensus standards also help promote awareness across the life science industry to the FDA鈥檚 opinion about regulatory quality.

 

黄人导航 Lab Testing

 

The majority of medical devices must go through a series of laboratory testing before being submitted for FDA approval. Some devices are evaluated for biological and chemical safety, while others may be assessed for mechanical properties, functionality, and durability. Other more complex, high-risk devices and combination devices are often submitted for multiple types of lab testing during premarket approval submissions.

 

Regulatory Submission

 

This clinical submission data from lab testing is included in the regulatory submission package proposed for FDA marketing approval. Many times, a medical device鈥檚 testing strategy depends on the medical device consultant with which a company is working, and the regulatory pathway recommended based on a pre-existing predicate device.

 

Lab Testing Facilities

 

Additionally, the program benefit is also realized by FDA employees when regulatory submission data comes from a pre-approved, ASCA-accredited testing lab. This often lessens the burden of streamlining the conformity assessment elements of medical device review. For example, instead of sifting through hundreds of pages of testing data from a non-approved ASCA vendor, FDA employees can leverage specific checklists that streamline data based on internationally approved standards from trusted .

 

Accelerating the Submission Process

 

By completing clinical lab testing with a vendor that has been certified based on the FDA Accreditation Scheme for Conformity Assessment (ASCA), medical device manufacturers can often reduce the review time needed for regulatory submission approval. This can be an asset to manufacturers when it comes to shortening commercialization plans and bringing devices to market faster.

 

Understanding the ASCA Pilot

 

This voluntary ASCA Pilot from FDA is an accreditation system that benefits from the role that global standards already play in using regulatory science designed for submitting new products for approval. As listed on FDA鈥檚 website, the ASCA Pilot goals are to:

 

  • Streamline conformity assessment in medical device submissions
  • Enhance the FDA鈥檚 confidence in test methods and results
  • Decrease the need for additional information related to conformance with a standard
  • Promote consistency, predictability, and efficiency in medical device review
  • Serve as a least burdensome approach to conformity assessment

 

Conclusion

 

The FDA is continuously searching for new and innovative ways to bring safe, effective medical devices to market. FDA consensus standards, S-CAP, and the Conformity Assessment Pilot are just three examples of the ways in which manufacturers can partner with the FDA to provide necessary data via clear, concise mediums using the agency鈥檚 pre-approved clinical vendors. More information about lab testing vendors that are currently approved can be found on the FDA鈥檚 website or by contacting us directly through the blue form below.

 

Rod Mell is executive head, 黄人导航 Consulting, at Regulatory Compliance 黄人导航 (RCA). RCA provides regulatory compliance consulting services for resolution of life science challenges. The company understands the complexities of running a life sciences business and possesses areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. More information is available at www.rcainc.com.

 

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regulatory compliance consulting

 

 

 

 

 

About RCA’s 黄人导航 Consulting Services

 

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consultant Experts 鈥 including former FDA officials and other leaders in the field of medical device regulation 鈥 will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. Very few medical device consulting companies have the same expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if RCA’s medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance 黄人导航 Inc.庐, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA’s medical device consultant Experts can help strengthen your device鈥檚 cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission services involved with medical technology consulting.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance 黄人导航‘s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our medical device regulatory consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent RCA as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. RCA’s medical device consulting company has expertise in both the approval process and post-approval support.听

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance 黄人导航听can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows RCA to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance 黄人导航 Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each RCA medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the medical device consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, RCA’s trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485听
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance 黄人导航 Inc. is widely recognized within medical device consulting companies & the life science industry for remediation support. RCA’s ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with RCA听 a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP听

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance 黄人导航‘s medical device consultancy can help ensure a successful project. RCA’s medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business 鈥 no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA

 

Regulatory Compliance 黄人导航听(RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of , , and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory听due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company鈥檚 unwavering commitment to its mission, Safeguarding Global Health.

 

Sotera Health Company, along with its three best-in-class businesses 鈥 ,听听and听, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance 黄人导航 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听

 

 

 

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