FDA announces a list of 510(k) exempted devices as well as a final rule on premarket submissions

January 14, 2020

The United States Food and Drug Administration has made two new announcements entering into the new year. Firstly, the Agency has published a list of devices that are now exempt from 510(k) submission; and secondly it has instilled a new final rule eliminating paper submissions for premarket notifications.

A list of 510(k) exempted devices is published by the FDA

Per the 21st Century Cures Act, on December 30, 2019, the FDA published a list of Class I and Class II medical devices now considered exempt from premarket notification.

The agency’s action is published in the Federal Register, detailing those who no longer have to apply for 510(k) clearance from the FDA. The agency’s action would decrease the regulatory burden on the MedTech industry and eventually could assist in the reduction of health care costs in the United States.

Agency exempted devices include:

  • Clinical chemistry test systems
  • Clinical laboratory instruments
  • Clinical toxicology test systems
  • Hematology and pathology devices
  • Immunology and microbiology devices
  • Ophthalmic devices
  • Radiology devices

Although these devices are exempt from 510(k) submission, they are still subject to other statutory and regulatory requirements. This is to ensure that reasonable safety and effectiveness requirements are met before they are brought to market.

For a more exhaustive list of all devices included under this new action, click here to be directed to the Federal Register.

Final rule: premarket submissions

In addition to the FDA identifying devices that are exempt from premarket notification, the Agency also issued a final rule to change regulation on medical device premarket submissions. Requirements for paper and multiple copies for submissions are no longer required by the Agency. Instead, the submission will be entered once, electronically. Electronic submissions have been offered in the past, but this new move to go paperless allows the FDA to work towards creating more sustainable and efficient methods for the submission program. This final rule applies to all submission types as specified in section 745A(b)(1) of the Federal Food, Drug, and Cosmetic Act, which includes 510(k) submission types. Not only does this rule allow for firms to save costs but it also doesn’t add any additional regulatory work for the Agency, reducing the burden on both sides.

This rule comes into effect on January 15, 2020. Read the full rule on the Federal Register.

How TSG can help

TSG’s consultants have experience with various premarket submissions including the 510(k). We assist clients in determining if a product is exempt from submission, as well as help them find the most appropriate path to market. Our consultants develop submission strategies that best suit the client’s needs, implement the devised strategy as well as diligently follow the submission process, addressing any issues that may arise along the way. We can represent clients in pre-submission meetings and can act as a liaison with regulatory authorities. To learn more about what we can do for you, contact us at info@tsgconsulting.com

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