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510(k) Streamlining and Lessons Learned

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Author: Erin McDermott, Account Manager Life Sciences

Attending a Virtual Conference

Reed Tech Navigator for Medical Devices 510(k) researchAs is the rest of the world, the MDMA FDA 2020 Forum seemed to be in a place of uncertainty leading up to its scheduled occurrence last Thursday & Friday in Palo Alto, CA. However, just days before the conference, MDMA made the wise decision to continue but move to a virtual setting—making this my first quarantined workshop! I was especially interested in attending this workshop to better understand the concerns our Life Sciences customers have and how we at Reed Tech can best help them. 

Throughout the two-day forum, the FDA covered updates and improvements across the breadth of the premarket process. What was very clear? The FDA’s focus on streamlining and capitalizing on lessons learned. They are working to get devices to the market quickly while maintaining a high level of safety and quality.

510(k) Policies and Pilots

As in previous years, 510(k)s were a big focus for the FDA. Updates revolve around shortening decision times and keeping clear, consistent communication throughout the decision process. Some of the strides made include Refusal to Accept Addendum Policy, Day 10 Call Policy, Least Burdensome Flag, and Quality in 510(k) policy to name a few.

Refusal to Accept Addendum Policy assesses whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review. In layman’s terms, the application is not complete and it isn’t a wise use of the FDA’s resources to have their reviewers focus on this application. If you have questions about the RTA, it is best to reach out to the reviewer directly. Again, the purpose of this policy is to get devices onto the market as quickly as possible.

Another policy that focuses on efficiency is the Day 10 Call Policy which is an offer for early clarification. Rather than heading down the wrong path, you have an opportunity to converse with your reviewer and identify that you are both on the same page and working towards the same goal. The FDA representatives highly stressed that you should always schedule a Day 10 call – you can always cancel it later!

Perhaps one of the most interesting policies is the Least Burdensome Flag. If you disagree with a decision made by your reviewer, you can “throw the flag” and provide a short email with deficiencies under disagreement, communications with team management, and a proposed path. This will trigger a senior management review of the file. It is important to note that the Least Burdensome Flag is limited to 1-2 topic areas and must be thrown within 60 days of additional information requests. Keep in mind, you must have made a good faith effort before utilizing this policy.

Finally, the Quality in 510(k) Program Pilot is an alternate way to submit a 510(k) to the FDA using the eSubmitter software to format the submission for certain device types. The FDA has identified a list of product codes that are eligible for this pilot. To utilize this program, you must already know the product code you want to use, try not to do an RTA, and try not to put it on hold. (Reed Tech Navigator for Medical Devices can help you find the best product code to use!) A final decision by the FDA can be expected by day 60.

Patient Device Innovation

Another interesting focus of the forum was Patient Device Innovation. Industry is now involving patients in collaboration for advancing device innovation. Or as it was put, “Patients are co-pilots not passengers.” This level of innovation has been sparked by increased access to information and devices that can be used at home, thanks to the internet. All-in-all this has led to the CDRH Patient Science & Engagement Program which has as its mission “to engage with patients, understand their perspective, and proactively integrate the patients’ perspectives into the total product life cycle of medical devices to help protect and promote patient-centric public health.” The program is inspired by patients and driven by science. It relies on Patient Experience Data which is presumed anything the patient can describe what it’s like ‘to walk in their shoes’.

Patient Preference Information (PPI) includes preferential information that fills a knowledge gap and helps in product development, clinical trial design, and risk-benefit assessment.

Patient-Reported Outcomes (PRO) are part of the clinical outcomes assessment that can show us what is versus what might be. This information is helpful in all submission types. It is allowing the exploration of potential novel approaches for patient sciences—including PPI in early feasibility studies, the interplay between PRO & PPI, sharing of decision-making tools, digital health technology for remote data capture, and social media in signal detection. The FDA representatives noted that there have already been many lessons learned about PPI & PRO such as consult the FDA early and often, develop a plan for recruiting patients and ensure patient comprehension of items and response choices.

Non-Device Clinical Decision Support

Finally, the forum focused on the 21st Century Cures Criteria for Non-Device Clinical Decision Support (CDS). The 21st Century Cures Act amends the definition of “device” in Federal Food, Drug, and Cosmetics Act to exclude certain software functions intended. For example, general wellness software may no longer be considered a “device.” To be considered, it must be low risk, maintain or encourage a “general state of health or healthy activity,” and intended use relates to helping reduce the risk or impact of certain chronic diseases or conditions.

To be considered for CDS, the manufacturer or developer must describe their software including the purpose or intended use of software function, intended user (ie: ultrasound tech), inputs used to generate recommendation, and basis for rending a recommendation. Additionally, all four of the following criterion must be met:

  1. NOT intended to acquire, process, or analyze
  2. Intended displaying, analyzing, or printing medical information about a patient
  3. Intended supporting or providing recommendations to a healthcare professional
  4. Intended for the purpose of enabling such health care professional to independently review the basis for such recommendations that such software presents

In addition to these topics, there were discussions around the growing De Novo market, Premarket Approval Review Considerations, Best Practices for Pre-submission, Breakthrough Device Pathways, and Medical Devices Inspections.

Overall, the conference was very informative. Our data and analytics tool, Navigator for Medical Devices, contains a single, streamlined and standardized search of 510(k)s, biologic 510(k)s, and De Novos so naturally, we stay on the forefront of premarket developments and regulations. To hear more about the discussion around any of these topics, feel free to reach out to me at emcdermott@reedtech.com or 267.961.0232. Additionally, feel free to sign up for a free two-day trial by clicking below!

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