Safer Technologies Program for Medical Devices

by | Sep 26, 2019 | FDA, Medical Devices, Quality Systems, Regulatory, Requirements

FDA has introduced a new program for medical devices and for device led combination products. Under this program are devices that do not qualify to be cleared via the breakthrough program but significantly improve the safety of the currently available options that treat diseases that are non-life threatening.1

Devices and device led combo products that are required to submit either a PMA, 510(k) or a De Novo are eligible for this program. Under the ‘Safer Technologies Program’ aka ‘STeP’, manufacturers can expect an expedited assessment and review process for their device while still keeping the same regulatory requirements for premarket submissions.

The factors considered while evaluating the eligibility of a product for the STeP are:2

  • The severity of the disease/disorder being treated or diagnosed by the device.
  • Should not be eligible for the Breakthrough Devices Program
  • How a device in STeP is expected to improve the benefit-risk profile of a treatment or diagnostic compared to alternatives for the identified disease or condition, as well as the significance of the expected improvement.
  • The device should be subject to marketing authorization via PMA, De Novo, or 510(k) pathways.

FDA might accept multiple devices into STeP that are intending to address the same safety issue or improvement.

This program will greatly promote innovation in the medical devices, advance patient care and facilitate timely access to safe and effective medical devices. The draft guidance for the ‘STeP’ was released on September 19, 2019 and is open for comments from the industry until November 11, 2019.

If you would like to submit your comments on the draft guidance, the docket can be found here: https://www.regulations.gov/docket?D=FDA-2019-D-40481

Have questions? Reach out to us at 248-987-4497 or email info@emmainternational.com.


1FDA (Sept 2019) Safer Technologies Program for Medical Devices retrieved on 09/19/2019 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medicaldevices?utm_campaign=091819_FIB_FDA%20issues%20draft%20guidance%20on%20the%20Safer%20Technologies%20Program&utm_medium=email&utm_source=Eloqua

2FDA (Sept 2019) Safer Technologies Program for Medical Devices retrieved on 09/19/2019 from https://www.fda.gov/media/130815/download

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

FDA Adverse Event Reporting 

FDA Adverse Event Reporting 

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public. 
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
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.

Ready to learn more about working with us?

Pin It on Pinterest

Share This