A wide range of medical devices are introduced almost daily in today’s global marketplace, which is often marked with the challenge of adhering to the industry’s constantly-changing international standards and guidelines. Planning for biological safety is as much a business necessity as it is a regulatory requirement. Any novel device must undergo assessment for biological hazards, risk characterization and toxicological risk assessment while also meeting the test requirements of varying international marketplaces and geographies. As a trusted medical device regulatory consulting partner, BIOMEDISCA can help you identify and mitigate these risks. At BIOMEDISCA, we offer a range of biological safety solutions to ensure your medical device development program is compliant, while also focusing on the most efficient means possible to complete necessary tests.
Biological Evaluation Plan
This is the first step of the biological evaluation for medical devices. This step is most often utilized for new devices not previously marketed, and may be needed for existing devices undergoing modifications. The Biological Evaluation Plan summarizes and characterizes a medical device based on the nature and duration of body contact, assesses the selection and materials of construction, reviews the manufacturing processes, identifies the biological endpoints of concern, evaluates any existing research data available and recommends and supports a strategy (plan) to address areas of remaining biological risk, which may include both chemical and biological testing.
Biological Evaluation Report
As part of a Biological Evaluation Report, BIOMEDISCA’s biological safety experts perform an overall evaluation of a device/family of devices with specific consideration to the type of patient contact and intended clinical use, potential hazards associated with the materials of construction, the history of clinical use of the materials of construction, manufacturing process information, the results of biocompatibility and chemical characterization testing performed on the device, the clinical history of the device, and other information available within the literature. The biological evaluation report is prepared according to the current requirements for the biological evaluation of medical devices (i.e. ISO 10993-1, FDA Biocompatibility Guidance, ISO 14971) using a risk management-inspired structure as outlined below.
Toxicological Risk Assessment
This assessment evaluates the toxicity of individual chemical ingredients of the formulation used to manufacture a particular medical device. The assessment typically includes tests for chemical composition, extractables and/or leachables, and evaluation of any degradable or leachable materials to determine patient biological risk. This assessment is often a component of a Biological Evaluation Report where analytical chemistry testing is performed.
Equivalency Assessment
BIOMEDISCA’s Equivalency Assessment evaluates the equivalency of a device to another similar marketed product. A typical request includes equivalency regarding data and properties for clinical, technical and biological parameters, methods of use, materials as well as equivalent clinical, technical and biological properties performance.
Peer Review
BIOMEDISCA’s team of Board Certified Toxicologists (DABTs) are available to provide credibility as a third-party reviewer and to vigorously critique scientific claims and research to ensure integrity of data and resultant claims.
Adverse Test Result Technical Memo
BIOMEDISCA’s technical experts can assist in delivering technical clarity of adverse results, associated implications and relevance to the known biological/toxicological endpoints relative to a specific medical device and regulatory pathway(s).
Gap Analyses
BIOMEDISCA offers comprehensive analyses detailing acceptable and deficient areas (Gap) between an existing set of data and new regulatory requirements for devices, including reports of remediation and sequence recommendations.
BIOMEDISCA’s U.S. Consulting Team is comprised of several former U.S. Food and Drug Administration (FDA) staff and industry experts, involved in over 500 U.S. FDA Pre-Submission applications in recent years. Leveraging our team’s experience and strong working relationships with U.S. regulators, Clients consistently place trust in BIOMEDISCA to accelerate clearance and approvals of innovative technologies.
Whether working on a stand-alone FDA regulatory submission or in a partnership with our inter-disciplinary teams of Preclinical, Clinical, Biostatistics and Reimbursement Strategists, BIOMEDISCA possesses a proven track record of successfully leading Clients through all stages of the product development process to mitigate regulatory risks and achieve commercial objectives.
BIOMEDISCA is proud to offer the following U.S. FDA Consulting Services to Clients around the globe:
510(k) Submissions
The majority of FDA Class II devices require a cleared 510(k) application submission prior to placement on the U.S. market. BIOMEDISCA’s FDA Consulting Team, which includes former FDA personnel, has experience in successfully submitting hundreds of 510(k) applications.
Our teams, specializing in medical devices and IVD products, assist Clients in navigating the 510(k) process and helping bring products to market in an accelerated manner. We work with you to reduce risk and circumvent common pitfalls throughout the regulatory submission process, including avoidance of Refuse to Accept (RTA) notifications and lengthy requests for Additional information (AI) upon FDA submission reviews.
At the outset of a 510(k) project, BIOMEDISCA’s experts work with you to identify the most appropriate predicate device(s), in addition to conducting an initial gap analysis of available information. This helps set the stage for what additional reports, testing and data will be required to provide you the best chance of a successful submission. As part of this process, our teams can also compile and submit a 510(k) submission on your behalf and help respond to any follow-up questions stemming from the FDA.
Breakthrough Device Program Submissions
The FDA’s Breakthrough Therapy Designation Program is a means to fast-track devices or device combination products. Commonly, if a device is accepted by the FDA as a breakthrough device, it can benefit from an expedited regulatory pathway via the Breakthrough Program.
Conditions that must be met to achieve breakthrough designation include demonstrating that a device provides more effective treatment/diagnosis of life-threatening or irreversibly debilitating human diseases/conditions and meet at least one of the following criteria:
BIOMEDISCA can assist Clients in making the determination as to whether or not their technology is likely to meet these requirements. We can also compile the presentation of a particular technology to the FDA, typically via a pre-submission (Q-submission) meeting.
De Novo Submissions
The U.S. FDA De Novo process is a means by which novel technologies that do not have an appropriate predicate device or product code, but for which general or special controls could provide reasonable assurance of safety and effectiveness, can ultimately be assessed by the FDA for premarket clearance.
There are two conditions under which a manufacturer can consider a De Novo request:
BIOMEDISCA recommends that manufacturers engage with the FDA via a Pre-Submission meeting to discuss the applicability of a De Novo submission under these circumstances. If the FDA supports a De Novo submission, the manufacturer will submit a De Novo request submission without reference to a predicate device. If it is accepted, then the manufacturer will be cleared to market the product in the U.S. and future applicants will have the ability to use the manufacturer’s product as a predicate device in their 510(k)s.
FDA Regulatory Strategy
The FDA regulates medical devices based on potential risks posed to patients. However, determining the classification and optimal roadmap to product clearance/approval is not always straightforward.
Key considerations for device makers, include:
BIOMEDISCA’s team of FDA consultants can help you answer all of these questions and more by developing a robust submission strategy that will also outline the likely timeframe and cost of bringing your technology to the U.S. market.
IDE Clinical Study Submissions and Reports
If a device maker is developing a new product/indication for an existing device prior to market approval and has determined a clinical investigation is required, the first consideration is whether the proposed investigation is considered a ‘significant’ or ‘non-significant’ risk to the patients. If determined that a clinical investigation will not pose a significant risk, then only an Institutional Review Board (IRB) approval is required before an investigation can commence. If, however, a device presents significant risk, both IRB and an FDA Investigational Device Exemption (IDE) is required.
Typically, IDEs are required for devices that must undergo a Premarket Approval (PMA) process—although 510(k) submissions still require some clinical data upon submission.
BIOMEDISCA can support companies wishing to submit for an IDE with the following processes:
PMA Submissions
Premarket Approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and performance of Class III (high-risk) medical devices. Given the risk associated with Class III devices, the device PMA process is more stringent, expensive and usually takes much longer than a Class II 510(k) submission.
A PMA submission can be a traditional PMA in which all requisite information is submitted in its entirety. However, another method is to submit a modular PMA where sections such as preclinical, manufacturing and clinical can be submitted separately to the FDA. This method is particularly appropriate if a company is collecting clinical data while other sections of the PMA have been developed and submitted.
Another important differentiation with PMA submissions is that a company’s manufacturing facilities and quality system will be audited by the FDA during the submission process and must meet the FDA’s requirements before PMA approval.
Post-approval, manufacturers must submit annual reports to the FDA, with ‘PMA supplements’ required for any significant changes made to a device or its claims.
BIOMEDISCA can assist manufacturers with PMA submissions through:
Q-Submissions
When a U.S. manufacturer develops their FDA regulatory strategy, there may be a number of unknowns surrounding required testing, the clinical data to provide and whether the clinical data already collected in a different market is considered sufficient. Rather than compile and submit your regulatory filing without answers to these fundamental questions—and risk a lengthy AI letter—BIOMEDISCA recommends that manufacturers consider submitting a Q-Submission to FDA to obtain clarity and to address potential concerns before finalization of a regulatory filing.
Within the Q-Submission process, a manufacturer engages with the FDA at no additional fee to present key questions and receive specific feedback. While this process adds time at the beginning of any development project, in BIOMEDISCA’s experience, it undoubtedly provides manufacturers a better chance of achieving successful submission outcomes while shortening overall project timelines—saving valuable resources.
BIOMEDISCA’s Team of medical device regulatory consultants puts their expertise to work for you. Involved in over 500 Q-Submission/Pre-Submission meetings for 510(k)s, De Novos and PMAs, and weekly interactions with the agency we take great care to mitigate risk, pose the correct questions to the FDA and focus on acceleration of the approval process for your device.
Safer Technologies Program (STeP) Submissions
For companies developing products aimed at treating diseases/conditions associated with morbidities and mortalities (less serious than those associated with Breakthrough Devices), the FDA has a new and voluntary program—SteP—for these device types which are expected to significantly improve the safety of currently available treatments.
The aim of the program is to allow patients more timely access to devices by expediting the assessment and review of associated regulatory submission processes, be it a 510(k), De Novo, PMA submission. The program is modelled on the previously introduced Breakthrough Devices Program and similarly allows for interactive, complimentary and timely discussions with FDA.
U.S. FDA 483 Mitigation Projects and Strategy
Following any FDA inspection, a manufacturer may be presented with a Form 483, which typically outlines an inspector’s observations and potential violations of the Food Drug and Cosmetic Act and other related acts. As part of the inspection process, an organization may also receive an FDA warning letter for a variety of reasons.
Whether a company has received a Form 483 or warning letter, BIOMEDISCA can assist manufacturers in a number of ways:
As part of FDA’s Medical Device Registration and Listing requirements pertaining to medical device approval, organizations outside the United States must designate an FDA U.S. Agent. (Click here to view information from the FDA on U.S. Agent responsibilities.
All foreign establishments must notify the FDA of the name, address and phone number of their U.S. Agent. The U.S. Agent must either reside in the U.S., or maintain a place of business in the U.S., and must be available to answer the phone during normal U.S. business hours.
The responsibilities of a U.S. Agent are as follows:
Should you need additional services, BIOMEDISCA can provide regulatory, medical device testing, preclinical, clinical and quality/compliance services to meet FDA requirements for 510(k)s, PMAs and IDEs. These services include, but are not limited to: FDA annual establishment registration and device listing, official correspondent responsibilities, resolution of import issues, regulatory strategy, required biological and/or functional testing, clinical study design and conduct, medical device quality systems development/implementation and writing regulatory submissions.
BIOMEDISCA is the medical device industry’s leading Contract Research Organization (CRO) that provides clear direction and focus to assist manufacturers seeking to commercialize in varying geographies and markets, including EU Member Nations, Canada, Australia, Switzerland and others.
Some of BIOMEDISCA’s most requested registration solutions include:
Biomedisca is a leading medical device company dedicated to developing innovative solutions for the healthcare industry. With a focus on research and development, our team of experts is committed to creating cutting-edge medical devices and therapies that improve patient outcomes and enhance quality of life.
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