Bringing a device to the market in the United States may appear complex. Following these four steps may assist you to navigate the process. Four steps to bring a device to the market:

• Step One: Classify Your Device and Understand Applicable Regulatory Controls
• Step Two: Select and Prepare the Correct Premarket Submission
• Step Three: Send your Premarket Submission to the FDA and Interact with FDA Staff During Review
• Step Four: Comply with Applicable Regulatory Controls Including the Establishment Registration and Device Listing

The technical document format for medical devices submitted to the U.S. FDA varies depending on the regulatory pathway, such as a Premarket Notification [510(k)], Premarket Approval (PMA), or De Novo classification request. Refer to Step 2 for how to prepare and submit the documents for FDA.

The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. 

The Center for Devices and Radiological Health (CDRH) accepts and encourages the inclusion of clinical data in electronic (non-PDF) form as supporting material to a premarket (PMA or 510(k)) submission.

This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions

Under the user fee system, medical device companies pay fees to the FDA when they submit a premarket submission to market a new medical device in the U.S., and when they register their establishments and list their devices with the agency.

Elements of declaration of conformity – 
a.Name and address of the applicant/sponsor responsible for the DOC
b.Product/device identification, including product codes, device marketing name, model number and any other unique product identification data specific to the DOC in question
c.Statement of conformity
d.A list of standards for which the DOC applies, including, for each standard, the options selected, if any
e.The FDA recognition number for each standard
f.The date and place of issuance of the DOC
g. Signature, printed name, and function of the sponsor responsible for the DOC
h. Any limitation on the validity of the DOC (e.g., how long the declaration is valid, what was tested, or concessions made about the testing outcomes)

CFG typically refers to a Certificate to Foreign Government issued by the U.S. FDA. A CFG certifies that a medical device can be legally marketed in the U.S. and complies with the Federal Food, Drug, and Cosmetic Act. It is often required by foreign regulatory bodies for device registration. This certificate is voluntary, not mandatory for exporting legally marketed devices. 

These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed.

Reportable incidents for medical devices under the FDA include events that lead to death, serious injury, or device malfunction that could result in death or serious injury if it were to recur. These incidents fall under the Medical Device Reporting (MDR) requirements outlined in 21 CFR Part 803.

For manufacturers: Submit reports of deaths, serious injuries, and certain malfunctions within 30 calendar days of becoming aware of the issue.
 For Importers: Report deaths and serious injuries to the FDA and the manufacturer within 30 calenda

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. 

The FDA does not oversee advertising for most Over-the-Counter (OTC) devices, as these are not considered "restricted" and are regulated by the FTC. However, for restricted devices, the FDA mandates that all advertisements include a brief statement of the product's intended use, relevant warnings, precautions, side effects, and contraindications, alongside the device's true established name, according to the U.S. Food and Drug Administration (FDA). 

As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR through the CDRH Portal for CDRH or the Electronic Submission Gateway (ESG) for CBER. De Novo, Pre-Sub submissions, and certain PMA application and supplement types can be voluntarily submitted as eSTARs through the CDRH Portal or mailed to the FDA.