FDA proposes to exempt more than 300 devices from 510(k) Requirements

March 21, 2017


On 14 March 2017, FDA proposed to exempt more than 300 devices from 510(k) Requirements.

Key Points:

  • US FDA has proposed exempting nearly 340 Class II medical devices from 510(k) requirements.
  • The exemptions are part of the 21st Century Cures Act, passed on December 13th, 2016.
  • Newly exempt devices will still need to meet other FDA regulations such as 21 CFR Part 820.

Proposed exempt Class II devices includes:

Medical equipment

  • umbilical clamps
  • obstetrical forceps to specific ophthalmoscopes
  • single-use endoscopic magnetic retrievers

Tests and reagents

  • over-the-counter benzodiazepine tests and
  • cocaine enzyme immunoassays used for employment and insurance testing

FDA’s rationale for exemption of these devices:

  • Decrease regulatory burdens on the medical device industry
  • Eliminate private costs and expenditures required to comply with federal regulation

The federal register for the Medical Devices; Exemptions from Premarket Notification: Class II Devices was posted for comments on 03/14/2017, see link below.  The comment period ends on 05/15/2017.