When you’re considering the US market for your product, you may have spent hours browsing through the internet, reading through mountains of regulations, guidance documents and standards, researched published white papers and yet… you’ve not been able to answer one fundamental question, “Do you have the right 510(k) strategy?”
As with any other regulatory process, establishing a good 510(k) strategy will allow compliance of your business with its legal obligations:
- Unless exemption applies, marketing a device without PMA approval or 510(k) clearance renders the device “adulterated” or “misbranded” (FD&C Act Section 501 & 502)
- Marketing an “adulterated or misbranded device” is a “prohibited act” and can trigger FDA enforcement action such as Injunction (21 U.S.C. § 332), Civil Penalties (21 U.S.C. § 333(g)), Seizure (21 U.S.C. § 334) or even Criminal prosecution (21 U.S.C. § 333; 18 U.S.C. § 3571)
This is an extensive list of complicated terms that translate to potential Business interruptions, damages to reputation and even product liability. And that’s just the beginning of the story…
A common misconception
A poorly executed 510(k) strategy can have multiple impacts on your ability to market the device. For example, without a strong plan in place, you can experience:
- Product launch delays, resulting in opportunity loss
- Inability to market a product variant
- Reduction of claims (e.g. clinical benefits, patient population, environment for use)
- Reduction in performance specifications or product feature set, etc
The reality is that submitting a 510(k) is not a simple administrative task. It’s a highly strategic, complex, scientific and multi-disciplinary activity that needs careful consideration and planning. It is essential to understand the context of your submission to ensure the regulatory process selected, submission contents and timing all align with your stakeholders needs.
This includes identifying:
- the roles as to who will execute your 510(k) strategy (e.g. Design, Validation, Clinical, Marketing, QA, Regulatory)
- your stakeholders needs and the significance in the 510(k) process, for example:
- Business driver and customer requirements (e.g. time to execute strategy, key claims)
- Clinical use (e.g. prescription status, environment, know hazards)
- Patients and user population (e.g. contact type, disease state, human factors)
- FDA (Regulatory processes involved, guidance available and communication channels with the agency)
- the key product claims and main characteristics / specifications
- short / long term product and QMS changes
- predicate candidates and your submission strategy (e.g. comparative bench testing, clinical trial, literature research)
And the old saying “if it is not written it won’t happen” also applies here… make sure this strategy is documented!
Preparing the submission
To ensure a positive outcome is achieved through the 510(k) process, you must also clearly understand your objective throughout the process which is to:
- Demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device
- Make the process of the application as easy as possible for the FDA reviewers
The success of your submission depends highly on the quality of the supporting evidence. Good supporting evidence has a broad meaning but includes:
- Use of the relevant FDA guidelines to ensure
- The key performance data expected by FDA is included
- Administrative contents are adequate
- Adherence to your design control process to identify the relevant safety and efficacy data for the device
- Good documentation practices – Make sure all documents included in your submission meet the Quality System Regulation (21 CFR 820), use structured, logical/factual arguments and a consistent presentation.
The right time to submit
On completion of your submission package and prior to submitting your 510(k), you should establish a submission risk profile. To do this, you should:
- Identify data and aspects of the submission which are likely to raise FDA questions (e.g. data that demonstrates why differences with the predicate do not trigger new questions of safety or efficacy)
- Identify the possible scenarios that could occur as part of the FDA review process, their impact on your marketing strategy
- Implement the necessary mitigation plans
The outcome of this pre-submission review could result in the need to delay the submission until more data is collected, collecting more data to supplement existing evidence or discussing with the group alternate claims that would still be acceptable to the business. This decision should be taken very carefully, as it may result in a delay to market however to submit an application that’s incomplete, could also result in a delay in requiring further information or worse still, a rejection by the FDA.
You should also use this process make the necessary plans and prepare for the round of questions you may receive.
Managing the round of questions
Once you have reached +/- 60 days post submission, FDA may come back to you with substantive review questions (or “deficiencies”).
Your final response to FDA should be treated with the same rigour as your original submission:
- Immediately review all questions with your 510(k) team
- Define action plans, responsibilities and due date for each item
- Identify if you need to contact FDA for clarifications on their concern
- Assess the need for a Q-Submission if you are uncertain of your response
- Regularly review the progress made towards your response submission, keep a constant eye on your clock (at the time of writing, the response time is limited to 180 days)
- Review the risk profile of your response with the team and decide on the right timing to submit
Continuously managing and communicating your 510(k) strategy not only puts you on the right track to clearance but puts your business in control of the outcome.
Over the years, our consultants have developed methods to significantly reduce the probability of delays and failures to receive adequate FDA clearance on 510(k) submissions. We have had direct experience with dealing with FDA review panels and supported a broad range of products ranging from active, non-active, implantable or IVDs.
Whether you require support through training, consulting, or even establishment of your regulatory strategy and 510(k) submission, we are here to help! Contact us by email firstname.lastname@example.org or call +61 2 9906 2984. We would be pleased to discuss how we can help supporting your projects.