When is a premarket notification (510(k)) submission required before marketing a medical device under 21 CFR 807.81? Answer in under 100 words.

Details / How it works

Under 21 CFR 807.81, each person required to register under §807.20 must submit a premarket notification (510(k)) to FDA at least 90 days before introducing a device into interstate commerce for commercial distribution. The requirement applies to:

• First-of-a-kind devices – those not substantially equivalent to a device in commercial distribution before May 28, 1976, or to a device introduced after that date that has since been reclassified into Class I or II.
• First-time introduction by a registrant – even if the device itself has been marketed by others.
• Significant changes or modifications – changes that could significantly affect safety or effectiveness (e.g., design, material, chemical composition, energy source, manufacturing process) or a major change in intended use.

Numbers & thresholds

Exceptions & edge cases

A premarket notification is not required when:

• A Premarket Approval Application (PMA) under section 515 of the Act is pending before FDA.
• A petition to reclassify under section 513(f)(2) is pending.
• The change is consistent with a predetermined change control plan (PCCP) cleared under section 515C of the Act.

Additionally, the appropriate FDA Center Director may determine that a written request for an exception or alternative under §801.128 or §809.11 satisfies the premarket notification requirement for significant changes under paragraph (a)(3). Manufacturers of radiation-emitting electronic products must also comply with part 1002 reporting requirements.