What changes to a marketed medical device require a new premarket notification? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Details / How it works

Per 21 CFR 807.81(a)(3), a person who is required to register under § 807.20 must submit a premarket notification at least 90 days before introducing a significantly changed or modified device into interstate commerce.

The regulation identifies two categories of significant change or modification that trigger a new 510(k):

• Changes affecting safety or effectiveness — e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
• Major change in intended use of the device.

The baseline list of devices exempt from notification (because they are substantially equivalent) is set out in § 807.81(a)(1), referencing devices in commercial distribution before May 28, 1976, and devices reclassified into class I or II after that date.

Numbers & thresholds

Exceptions & edge cases

Under 21 CFR 807.81(b)(1), a premarket notification is not required when:

• A premarket approval application (PMA) under section 515 of the FD&C Act, or a petition to reclassify under section 513(f)(2), is pending before FDA; or
• There is a Predetermined Change Control Plan (PCCP) cleared under section 515C of the FD&C Act, provided the change is consistent with that PCCP.

Under 21 CFR 807.81(b)(2), the appropriate FDA Center Director may also determine that a written request for an exception or alternative granted under § 801.128 or § 809.11 satisfies the § 807.81(a)(3) requirement.

Under 21 CFR 807.81(c), owners or operators that manufacture radiation-emitting electronic products (as defined in § 1000.3) must additionally comply with the reporting requirements of part 1002.