Folks, I received a couple of emails from readers after posting last week’s guidance on Class I devices. First-off, thank you for reading and writing, and yes, Dr. D will honor your request by dedicating this week’s Devine Guidance to Class II device requirements in the United States and covering Class III device requirements in the following week’s guidance.
As most of you already know, FDA premises device classification based on risk. Low-risk devices are Class I and high-risk devices are Class III. The doctor is going to assume that this not earth-shattering news for the masses. So if Class I is low-risk and Class III is high-risk, then just maybe Class II is medium-risk (well, sort of). That is one way to look at it. For starters, similar to Class I devices, manufacturers of Class II devices are required to register with FDA as an establishment in accordance with 21 CFR, Part 807.
By the way did Dr. D mention you have to pay Uncle Sam $2,575 (for 2013) to register as an establishment with FDA? Additionally, all Class II devices, once cleared by DA, must be listed in the FDA User and Registration Listing System (FURLS). So what does cleared device mean Dr. D? Read on my dear readers (next section) and the doctor will provide some insight into cleared devices. The good news is Dr. D has never been categorized as being “labile” (look-it-up) just a little “insolent” and tenacious when on the pulpit pontificating about compliance. Enjoy.
Class II Devices
Well if you made it this far, the doctor is going to climb out on a limb and assume you are still interested in this week’s guidance. If you are continuing to read because Dr. D’s fine prose irritates you, that is okay too, Dr. D loves you man!
With a few minor exceptions, the regulatory path to obtain clearance from the FDA, for a Class II device, is through the submission of a well-written 510(k) that adheres to FDA guidelines delineated within 21 CFR, Part 807. The 510(k) is premised on their being a predicate device that has previously blazed the regulatory path and obtained FDA clearance. Remember for the 510(k), the submitter must list a predicate device (list one predicate, and if necessary multiple reference devices). The underlying concept of the 510(k) is to establish substantial equivalence with the claimed predicate.
There are 21 Sections associated with a 510(k). There is a good chance, not all sections may be applicable for your 510(k). If not all of the sections apply, do not list N/A and stop. The prudent path is to list the section as Not Applicable and provide a brief paragraph explaining why a section is not applicable. If the 510(k) is deemed incomplete, FDA will reward the device manufacturer with a “Refusal to Accept Letter.”
Similar to establishment registration fees, you must pay Uncle Sam for an FDA review of the 510(k). For FY 2013, the review fee for a 510(k) is $4,960 for a large business and $2,480 for a small business (revenue ≤ $100 million). As of December 31st of 2012, you must file one copy of the 510(k) electronically. By the way, have fun with the e-filing system as the software is not user friendly. If it is your first time, allocate a couple of days, especially if your 510(k) is enormous.
Once you have filed the 510(k), the fun begins. If FDA accepts the submission, the review clock starts ticking; tic, tic, tic, etc. If a device manufacturer does not hear from FDA after 90-days of a 510(k)’s initial submission, the manufacturer can file a Form FDA 3541 and ask for status. Just a quick note, at last glance, FDA was averaging approximately 141 days for each 510(k) review, so practicing patience really becomes a necessary virtue. For those of you that were not particularly clear with your submission or providing the necessary supporting documentation, now comes the endless barrage of questions from the reviewer. The doctor’s experience is that if you receive fewer than ½ dozen questions, then pat yourself on the back, you have done well; and seven or more, not so much. The good news is that at the end of the entire process is a letter from the FDA notifying your organization that the device(s) covered by the 510(k) is/are cleared to market in the United States; henceforth the term “cleared device.”
If you have failed to convince the agency that your device is substantially equivalent to the claimed predicate, there is a path for appeal through the use of the FDA appeals process and the use of an ombudsman (note process changed on May 17, 2013). Good luck with that. Just remember, it could always be worse, FDA could ask for clinical data to support the submission. If that happens, cha-ching, the price of admission to the U. S. device market place has just increased.
The doctor will leave the readers with three takeaways from this week’s guidance:
- One – make sure the predicate device you select for the 510(k) process is actually an equivalent device.
- Two – make sure the 510(k) is complete. Dr. D always recommends placing the checklist employed by the FDA reviewers in the front of the 510(k) so the reviewer can easily ascertain that the submission contains all of the required elements.
- Three – if you receive questions from the reviewer, provide the requested clarification or information quickly. If you do not want your 510(k) sitting on the reviewer’s desk collecting dust, a punctual response should be deemed mission critical.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2013, April) Title 21 Part 807: Establishment registration and device listing for manufacturers and initial importers of devices. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.