|Avoid brick walls by incorporating a|
Regulatory Assessment at the beginning
of new product development.
by Kimberlee Washburn
Regulatory Compliance Associates
The Importance of an Upfront Regulatory Strategy
It is unfortunate that so many new medical devices and new generation product launches are delayed due to the absence of regulatory input at the beginning stages of design control and the new product development process.
The best way to avoid this problem is to put into place a “Regulatory Strategy” or “Regulatory Assessment” document during your first design control stage. Some companies may choose to call this document the “Regulatory Strategy” and others prefer the term “Regulatory Assessment”, but for simplicity, I will refer to this as the “Regulatory Assessment” in this article. The Regulatory Assessment will house all of the regulatory planning information for the new medical device, or the “upgraded” or “modified” device that incorporates design changes.
At a minimum, the Regulatory Assessment should:
- Include product-specific regulatory requirements for each target market the product is intended to be marketed in (U.S., Europe, Canada, etc.). This may include, for example, requirements for certain technologies (i.e. Radio Frequency), labeling requirements, or product-specific testing requirements. These requirements should also be transferred to the products design input document(s).
- Be initiated as early as possible during design controls
- Be released as a controlled document, similar to a project plan
- Be used for a new product and/or modifications to a currently approved / cleared product.
- Be used for all FDA regulated product types (device, drug, biologic, combo)
- Include proposed claims, intended use and indications for use statements, and any contraindications
- Include product classification for all applicable markets (U.S. FDA / European Union CE Mark / Global Markets) – i.e. FDA Class I/II/III and FDA product code
- State what the impact is on current regulatory submissions, and any new regulatory submissions that are required including the submission pathway (510(k), De Novo, PMA, NDA, BLA)
- Include information on the timing and resources needed for the required regulatory submissions
- Incorporate regulatory planning for communication with regulatory agencies and use of pre-submission meetings with FDA and other applicable regulatory agencies
- Document the chosen predicate device(s). The timing of this is important in order to be able to take advantage of Freedom of Information Act (FOIA) requests to FDA for a copy of the predicate’s regulatory submission – these requests may take up to 90 days or more to receive
- Include decisions on the performance and comparison testing needed including bench, animal and clinical studies
- Include the standards (ISO, ANSI, etc.) applicable to the product and regulatory / quality testing requirements
- Include product characteristics such as biocompatibility, sterilization, electrical safety, EMC, data integrity, human factors, software, etc. and the associated regulatory requirements
- Include information on the reimbursement strategy, if available
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The impact on not defining the regulatory strategy upfront can be very great, including the need for product re-design, re-executing verification and validation testing, and not being able to market the product at all because of failing to meet regulatory requirements. This results in wasted dollars, time, resources and a negative reputation before customers and investors.
It is important to note that if the Regulatory Assessment is for a modified product, the specific list of design and product changes must exactly match existing changes when it comes time to revise the engineering drawings and specifications on change orders. Otherwise, the regulatory assessment may completely change. Additionally, any differences between the Regulatory Assessment as documented up front, and the changes that are actually realized in the modified product, will create a risk of nonconformance during agency audits, because the differences were not assessed for regulatory impact.
Regulatory clearance and/or approval for the product can take from three months to over a year for FDA-regulated products; you do not want to find this out at the end of product development, resulting in a significant delay to the product launch plans.
For companies that are working with investors, regulatory uncertainty will absolutely shy investors. Unfortunately, it is more commonplace than you may think for complete rounds of funding to be exhausted on products that never receive regulatory approval. Alternatively, it may at a minimum result in a change to an investor’s expectations if the funding was achieved based on inaccurate regulatory assumptions due to a lack of regulatory documentation and/or input into the product development process.
Unique Regulatory Strategies
Now that you have a documented Regulatory Assessment, you can leverage this important document to put into place staged regulatory strategies that will benefit your product and company in both the short term and long term.
Using Your Own Predicate
Demonstrating substantial equivalence between your medical device and a device designed and developed by a different company may prove difficult, as you do not have access to pertinent product information specifically included in the comparison that the FDA will perform. Therefore, finding a way to use a device that was designed and developed by your company as the predicate will be a very useful tool in a successful regulatory strategy. The benefits include:
- Access to all regulatory submission data (no redacted data)
- Comparison to exact product requirements and specifications
- Using the same testing protocols and report templates that FDA has already reviewed and found to be adequate
- The ability for your company to set the par for performance specifications
- Benchmarking and full visibility into the established risks and failure modes for the device – the same risks and failure modes from the predicate device will be expected to be included in the new or modified device’s risk management file, as applicable
- Visibility into what design changes will result in a product “correction” vs. a product “improvement”
Use of Your Novel Technology in a Lower Class Device
The pace of novel technology incorporated into medical devices is increasing by the minute. However, with the use of new technology comes significantly stricter regulatory oversight and requirements. You may consider the option of using your novel technology in a lower class device first, followed by using the novel technology in the device with which you are really expecting to storm the market. This is a regulatory strategy being employed by the advisement of seasoned regulatory professionals, and you can follow suit. This strategy brings about the following benefits:
- Faster regulatory clearance for the lower class (Phase 1) device, resulting in quicker entry to market and receiving valuable feedback from customers much sooner
- The ability to use this feedback on your novel technology to iron out any issues as seen in the field within a regulatory framework with less strict implications (lower class), including:
- Use errors
- Data communication or data integrity issues
- Information on materials used in medical devices for the first time while in a lower biocompatibility class
- Quicker realization of a “generation 2” or “generation 3” version of your device by being able to design and develop design improvements at a quicker pace while within a lower class regulatory framework
- Avoidance of harsh regulatory actions including MDRs, recalls or adverse events
Grouping of Regulatory Submissions
Another fairly simple regulatory strategy you can use is to bundle devices with minor design differences in the same regulatory submission. This creates a streamlined regulatory pathway by minimizing regulatory agency review cycles.
- FDA has more recently been asking for full transparency of product codes on labeling and submission documentation
- CE certificates and Declarations of Conformity for CE Marked products have included product codes historically
Use of Labeling Predicates
Your design and development team can realize a huge benefit by reviewing the labeling of similar devices currently on the market. In doing this, you will be able to:
- Document the risks and hazards that have already been identified by FDA for the device type
- Save time by leveraging regulatory labeling requirements and product information required for the labeling as the device may have the same risks, users, etc.
- Use as an input to your device’s risk analysis
Taking the time to develop an upfront regulatory strategy will not only facilitate and streamline your product clearance and/ or approval, it will also establish a consistent process to follow as you develop new products for the market.
As a Regulatory Affairs professional, Kim Washburn’s work has covered the U.S., European Union, Canada and over 70 global countries. She brings over 15 years of experience in the Medical Device, In-Vitro Diagnostics, Pharmaceutical and Biologics industries. Her areas of expertise include regulatory approval and new product development support, regulatory labeling, medical device software, FDA compliant design control and risk management, and technical writing. Prior to consulting, she held roles at Abbott Laboratories, OrthoSensor, Nipro Diabetes Systems, and University of Miami Tissue Bank. Kim received a BS in Biology/Computer Science from Illinois State University, after transferring from West Point (United States Military Academy). She can be reached at firstname.lastname@example.org.
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