FDA 510k

About 510k Premarket Notifications (PMN)

Section 510(k) of the Federal Food, Drug and Cosmetic Act covers regulatory requirements for manufactures of medical devices for sale in the United States. 510k’s (Pre-Market Notification or PMN) are based on Substantial Equivalence (SE). The basic premise is to demonstrate substantial equivalence to a medical device that is already marketed and FDA-approved for the US market. The 510k submission includes documentation to support the claim of substantial equivalence such as performance and description data. There are 3 types of 510k’s available for submission to the FDA – Traditional 510k, Special 510k and Abbreviated 510k. Special 510k’s and Abbreviated 510k’s were developed under the “New 510(k) Paradigm” to expedite the 510k approval process under special circumstances.

Traditional 510K: A Traditional 510(k) can be used for any medical device requiring 510k approval.
Special 510K: A Special 510(k) applies to a device modification. Special 510k’s utilize the QSR/Quality System Regulation (21 CFR 820) which applies to a medical device that has been previously cleared via the 510(k) process. A Special 510k includes a “Declaration of Conformity” to declare conformance with design controls without providing data, thus expediting the FDA 510k regulatory approval process.
Abbreviated 510K: An abbreviated 510k relies on the use of Guidance Documents, Special Controls and Recognized Standards and may expedite the process by avoiding the need to submit test data.

510k Consulting Services Overview

510(k) Pre-Market Notification (PMN) consulting services for medical device manufacturers – Services may include 510(k) notification consulting (consultants and advisors), 510k documentation preparation (descriptive data, test data, performance data, etc.), communication with the FDA, acting as a US Agent and Official Correspondent with the FDA, intermediary with third (3rd) party review and notified body, FDA audit guidance, etc.

Specific 510k related documentation and consulting services may include preparation of PMN 510(k) Notifications for review, including Traditional 510k, Special 510k (Device Modification) and Abbreviated 510k Submissions.

Specialties may include:

  • Substantial Equivalence (SE) Comparison
  • 510(k) Summary Statement
  • Device Classification and Registration Number and Regulatory Status – Class I, Class II, Class III, Unclassified
  • FDA Labeling
  • Indications for Use
  • 510k Device Description
  • Performance Compliance 21 CFR 807.87 D
  • Class III Certification and Summary (for Class III only)
  • Final Certification and Disclosure Statement for 510k notifications with Clinical Studies
  • 510k Kit Certification
  • Sterilization Methods: Biocompatibility, Sterilization Process Validation, SAL, Packaging, Pyrogen, ETO Residue and Radiation Dose
  • Software Documentation

Preparation for Review

  • Third Party Review by Accredited Persons (AP)
  • Expedited Review
  • Reclassification Letters

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