Many ask what's involved in obtaining 510(k) clearance for FDA-defined Class II medical devices for sale in the U.S. The following is my typical response:
The product would essentially have to be almost the same, if not the same (substantially equivalent) as a previously cleared product (the predicate), with the same safety and efficacy issues. Any variation would have to be extensively tested by a testing company or lab. And to prove being identical, similar testing would also be required. Several international labs can provide a list of tests and their costs. These tests would be included in the 510(K) submission together w/ labeling, packaging, etc.
The FDA charges a fee to review a 510(k) with no guarantees, ~$4100.00+ USD (payable at time of submission; which can be reduced if the company can show it meets their definition of a small business a 60 day review). The parent company would have to be registered with the FDA (another fee of over $3000.00) and have a compliant cGMP system in place, and its suppliers would need the same. Consultants such as myself provide assistance in those areas as well (or the company, or another party could do) at additional costs.
Charges run the gamut, from lows in the $4-5000's to $10,000-20,000, or more, depending upon consultant and project complexity, with costs going higher if an IDE (Investigation Device Exemption) / clinicals are involved. IDE's can cost as much as a 510(k) since they address much of the same requirements. Some consultants, such as myself, make charges payable in 1/3s, with the first third up front, prior to start on the 510(k). Product risk analysis per ISO 14971 is usually several thousand dollars extra, unless a company already has their own. The company would be required to pay all the test fees and FDA fees, such as those mentioned above. And there would be no guarantees (the FDA is currently evaluating and tightening their 510(k) requirements).
Timeline:
Lab testing ~2 mos
IDE / Clinicals, if required, can take a year or more (check with CROs or appropriate consultants)
Draft 510(K) ~2 mos (plus risk analysis, labels, etc) assuming availability of documentation
FDA Review ~ 4 mos average
And there are no guarantees. If your product is basically identical to the predicate(s) then clearance is likely. Any differences raise the chance of the submission being found NSE (not substantially equivalent). If such happens, there are several options:
1. Immediately refile a "de novo" application (if product is low risk);
2. Go back to the "drawing board" to address major issues, and refile another 510(k), with new fees;
3. File a PMA which is more expensive and can take several years.
J. E. Lincoln and Associates LLC Medical Device and cGMP Consulting: http://www.jelincoln.com/
Note: The FDA has moved toward encouraging more innovation to be allowed in 510(k) submissions and a move away from older technology (older 510(k)s based on older, less safe / effective technology) which has less patient benefit than most newer technology, but still allow such to be addressed under the faster 510(k) review process as opposed to the PMA process - modernizing the FDA 510(k) pathway:
https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-4
Add'l: FDA's 510(k) mod program includes their 1) Breakthrough Technologies, and 2) STeP (safety improvement) programs to allow some changes to SE (substantially equivalent) without leaving the 510(k) to go to De Novo or PMA; and Q-Sub[mission] to discuss proposed approaches, et al, with FDA prior to any formal submissions, with them agreeing to a binding decision as to what will be acceptable to the Agency.
Further, the FDA as of Oct 2023 requires all 510(k)s to be submitted by means of their "eSTAR" portal. De Novo or PMA submissions via eSTAR are optional currently.
-- JEL 10/20/24
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