Regulatory 101 for Medical Device Start Ups

by | Nov 13, 2020 | Uncategorized

In this webinar hosted from EMMA International’s Solutions Delivery Specialist, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.

Get the Regulatory 101 for Medical Device Start Ups Webinar

Fill out the form below, and the webinar will get sent directly to your inbox.
  • This field is for validation purposes and should be left unchanged.
Katie McCallum

Katie McCallum

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This