… continued from “Patenting your medical device in the USA”
Claiming substantial equivalence with a similar medical device in the market is the fastest path to obtaining regulatory approval to market in the USA – this option however is not always available to the bearer of a letters patent. Do not despair; in fact you should be celebrating, since you joined the revered class of world patent holders – besides, what is said about a rough road leading to the heights of greatness.
To claim substantial equivalence, you must find precedents. This is done using the premarket notification FDA 510(k) search engine. Suppose your company wishes to register a Surgical shoe for holding orthotic insert. The 510(k) search result will show surgical shoes with slippery inserts. Make sure to master the 510(k) number since you will reference it in your SE discussion. Identify the FDA standard codes used and study the format to write a summary.
STEP 1: Device Classification
The first most important step for all applications is the confirmation of the device’s classification. If your device is “510(k) exempt, then you are as good as having a non-medical device since it poses little or no risk to a patient. Irrespective of device classification, all manufacturers of medical devices are required to register and list their devices with the FDA. All Class I medical devices, with the inclusion of a select Class II devices are 510(k) exempt – again, do your assignment.
STEP 2: Company Registration
This section further reinstates the need for a patent attorney, who may double as an agent with designated office address in the United States – since your company (if any) is based outside of the USA, you require a front. Following an agreed protocol with your front, you should register your status as a Manufacturer or Specifications developer company and list your device with the FDA via its website. On the website, you’ll also find your device’s product code, and regulation number for its product category.
STEP 3: 510(k) Submission
After having registered your company, prepare a premarket notification 510(k) submission document and submit to the FDA. This is made much easier since the document is a preprint download with standard sections to fill.
STEP 4: Substantial Equivalence (SE)
See introductory paragraphs.
STEP 5: Processing
Your 510(k) application undergoes a similar process and duration as your patent application, following which you receive a formal report. A poorly documented application will be rejected at the first examination. This will necessitate modifying your application.
Eventually, you will be presented with a clearance to market confirmation letter containing your 510(k) registration number as listed in your company’s electronic record.