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If you are a Medical Device Startup planning to sell your product in the United States, then you are regulated by the FDA and the guide below will help you understand the FDA Process and save significant time / money.

*100% of startups surveyed from Y Combinator & QB3 recommend reading this.

 

1

FDA Classification

Are you a Medical Device in the eyes of the FDA? 

The FDA considers you a Regulated Medical Device if your product matches their description.

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

If you make a Medical Device the next step is to determine your FDA Classification. Your classification & 3 letter code will determine the statutes you must follow to comply with FDA regulations. 

There are 4 possible FDA Classifications for your Medical Device.

  • Class 1 (very low risk)

  • Class 2 (higher risk)

  • Class 2 - Special Requirements

  • Class 3 - PMA (Pre Market Approval required, Very High Risk, Potential of Death)

Follow these steps to determine your FDA Classification.

  • Find your competitors listing on the FDAs web site.

  • Is your competitors intended use the same? If so you can use this classification. (ideally you want the lowest classification possible).

  • Locate their 3 letter code. The 3 letter code is associated to a 7-Digit statute (XXX-YYYY) .

  • Query the FDA classification search engine, this will tell you the classification of your product, if applications are necessary, how you need to register, and the type of Quality Records (aka, Quality Management System) you need to keep.

 

2

FDA Applications

Not all Medial Devices require an application to the FDA.  

There are 3 categories of FDA applications: De Novo, 510(k), and PMA

De Novo - FDA link

  • When your indications for use are new, and there’s really nothing else with a similar intended use.

  • Note: Class 1 is preferable to a De Novo application.  If you can find an intended use that’s class 1 you’re better off going with that than with a De Novo Application.

510(k) - FDA link

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.

There are 2 ways to determine if you need to apply for a 510(k)

  1. Ask.

    • You can ask the FDA.  

    • This is a called a G letter.

  2. See the statute.

510(k) Application costs

  • $5k to apply through the FDA.

  • $2.5 -> upwards when applying through an independent third party.

510(k) Process & Timeline

  1. First, assemble the application

    • Generally we recommend you allocate 2+ months for a person to focus on this full time.
    • We’ve seen 510(k) applications come together in as little as 5 weeks (1 competent & experienced person, full time for 40 hours, or 200-human hours)
  2. Submit the application
    • Within 90 days they will either accept or reject your application.
    • If they reject, they give you details as to why.
    • Often,  rejects are related to test data, which can take several weeks to collect.
  3. Reward
    • K number - lets you enter the market.

PMA - Class 3

  • Requires animal / human trials.

  • Can require millions of dollars to conduct trials.

  • The application can often take a year (or more) to put together.

  • The response will come back within 180 days.

    • Pass = you will be assigned a P number and can go to market.

    • Fail = You have 180 days to respond.

  • The FDA will conduct an on-premise visit before a P number is awarded.
 

3

FDA Required Quality Records

Your, "Quality Management System"

To sell a Medical Device, the FDA requires you to maintain a QMS (Quality Management System).  

A QMS contains the following: 

  • Quality Manual
  • Procedures
  • Work Instructions
  • Forms and Signed Records. 

 

 

4

FDA Registration

Registering with the FDA is the last step in the process before launching.

If you are required to submit an FDA Application (De Novo, 510(k), PMA) you would register after having received acceptance from the FDA. 

If you are not required to submit an FDA Application you would register with the FDA immediately before launching (advertising / selling) your product in the US.

 

5

FDA Audit

The FDA is legally empowered to inspect you unannounced anytime after you have launched (started advertising / selling) your product.

FDA Audits are normal.  The higher your classification, the greater the chance of an Audit. The are likely to happen more often for higher risk products. They also can happen if there is cause including complaints through the Medical Device Reporting or the FDA complaint phone line.

The FDA Audit process - what to expect.

  • An FDA Auditor will arrive at your place of business, unannounced, with a 482 search warrant.

  • The FDA Auditor will review your Quality Management System (QMS) to ensure you are keeping required Regulatory / Quality records.

  • The FDA Auditor will give you a list of problems with your QMS (referred to as a 483) - you have 30 days to respond.

  • The FDA Auditor may remove samples from your office.  If they take samples they will give you a receipt, called a 484.

  • If your Medical Device startup doesn't respond / correct the items listed in the 483 within 30 days your CEO may receive a Warning Letter. You do not want this. A Warning Letter is public domain, lists the CEO by name, and is seen by everyone; it can kill your startup.  Warning letters scare away investors & customers. If you receive a 483 do everything in your power to fix all items immediately.