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Specializing in FDA Regulatory Matters

Getting Your Medical Device Into the U.S. Market

If you are a manufacturer whose medical device is either a Class I, or a 510(k) exempt device Class II device, consider yourself and your company lucky that you do not have to try to “thread the needle” of the litigious and arduous process known as 510(k) clearance. Getting a device ready for 510(k) submission is usually time-consuming, costly, and full of challenges.

All 510(k)’s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. If you are the maker of a Class II medical device or an IVD and want to launch it in the U.S. market, you must submit a 510(k) to the FDA. For Class III devices, a premarket approval (PMA) submission is needed.

510(k)’s have unique content and format requirements – they are not identical to a European Technical File – and the FDA’s recent changes to 510(k) requirements make the submission process more rigid than ever.

Class II devices are designed to perform as indicated without harming patients or users, but they require a greater level of safety and effectiveness assurance than do Class I devices. Examples include powered wheelchairs, infusion pumps, surgical drapes, surgical needles, suture material, and acupuncture needles.

Class III medical devices do not have enough information to ensure safety and effectiveness through the general or special controls used for Class I or Class II devices. These higher-risk devices need premarket approval (PMA), which includes a scientific review, to ensure their safety and effectiveness. Examples include replacement heart valves, silicone gel-filled breast implants, and implanted cerebral stimulators.

Here are some practical tips for a 510(k) filing:

  • Establish a “Regulatory plan” as early in the process as possible. The regulatory plan should include a list of all the deliverables required. The plan needs to be owned by all the applicable team members not just the person issuing the plan.
  • Don’t be surprised or disheartened that questions will arise despite your best efforts. The FDA is swamped with 510(k) reviews and any deficiency that they can find in your submission allows them to go to the next submission to keep the commitment that the FDA will review all submissions in a timely manner. “Put yourself in the FDA examiner’s shoes”.
  • Don’t try to blind the FDA examiner with excessive or extraneous information in the hope that they will bypass the information for the sake of time. In my experience, the FDA examiners read every document and every page!

The FDA sends back most 510(k)’s during the first review cycle to request more information – in recent years this has applied to more than 70% of 510(k) submissions!

Also, many medical device companies are compiling and submitting 510(k)’s to the FDA for review without establishing a Quality Management System and without documenting Design Controls and without documenting Risk Management which can bode trouble for the submission as well as FDA inspection time.

You might want to consider using a competent consultant or at least asking an objective party to review the submission for completeness before sending it to the FDA. This will minimize the risk of delay and rejections.