Posted on July 23, 2015 in MassMEDIC Blog
Tips for saving time and money on medical device clearance
By Christina Bernstein, President, BB Medical Surgical, Inc.
Since 1976, FDA has classified medical devices as low-, medium-, and high-risk. Only high–risk devices (Class 3) are subject to testing in humans and post-market follow on reporting. The majority of devices sold in the USA are Class 1 and Class 2. FDA grants clearance to market Class 2 devices that demonstrate substantial equivalence to devices already on the market.
What this means for developers:
- Some devices that are made with new materials can be tested in the lab and on the bench (but not in humans), then sold as Class 1 or Class 2 quite cost effectively.
- Patients and consumers think that because FDA cleared a device, that device is known to be safe for use in humans. Manufacturers must uphold that trust.
How to save money during the development/clearance/approval process
Recognize that this like running a marathon – sprinting in parts will just lead to hitting the wall near the finish line. And the finish line may very likely move.
- Take advantage of the recently formalized Pre-Submission process. This process allows you to perform much of the front-end work before paying the application fee and starting the clock, including writing the draft 510(k), and proposing test protocols and data formats. If you identify every single indication for use and every version of the device, you can submit a bundled 510(k) and only pay one fee when the time comes. However, it may take longer in the review process.
- Work with test labs to make sure your protocols are aligned with standards from FDA, ISO, ANSI/AAMI, USP and the EU. Also ensure that the test suites are done sequentially – if something fails then you are not on the hook for a lot of other tests if you have to revise the device. The test labs can be really helpful in suggesting alternative tests if a certain protocol is expensive.
- FDA has a manufacturer database that shows manufacturer inspections and warning letters. Look up everything on competing products and especially the predicate device if doing a 510(k). Make sure not to repeat mistakes. FDA data is fast and free to look up.
- Get a wide variety of people to identify hazards and evaluate risks for the device. Do not rely on engineers and quality/regulatory to identify assembly issues, logistics issues or clinical use issues. The more varied the group the better your device will be. At a minimum you will need a user of the device, the engineer (s), production and packaging input.
- Dry run the production line and packaging processes before submitting a 510(k) – it will cost you far less money to identify problems and correct them at this stage. This is especially crucial if using contract manufacturers – if they are offshore, get on the plane now!About Christina Bernstein
- Copyright 2015 BB Medical Surgical
- With 20 years of business experience, including MedTech engineering, regulatory/quality and marketing/sales, Bernstein is an expert in bringing new medical technologies to market in an efficient and cost-effective manner. She has extensive experience in guiding MedTech companies both in the U.S. and abroad through the FDA 510(k) approval process and down the path to profitable commercialization. Bernstein can be reached at firstname.lastname@example.org.