Inspections, Compliance, Enforcement, and Criminal Investigations

Medical Device Tracking

CAPA Medical Device Tracking

Medical Device Tracking

Inspectional Objectives

  1. Determine if the firm manufactures or imports a tracked device.
  2. Verify that the firm has established a written standard operating procedure (SOP) for tracking that complies with the requirements in 21 CFR Part 821.25(c).
  3. Verify that the firm's quality assurance program includes audits of its tracking system within the appropriate time-frames specified in 21 CFR Part 821.25(c)(3).

medical device tracking decision flow chart

Medical Device Tracking

Narrative

Purpose/Importance
The purpose of the Medical Device Tracking Regulation is to ensure that manufacturers and importers of certain medical devices can expeditiously locate and remove these devices from the market and/or notify patients of significant device problems.

checkmark1. Determine if the firm manufactures or imports a tracked device.

Ask the Management Representative (or designee) whether the firm manufactures or imports any device subject to the Medical Device Tracking Regulation (21 CFR Part 821). If the firm does not manufacture or import a device subject to the tracking regulation, you can terminate your tracking inspection.

If the firm does manufacture or import a device subject to the tracking regulation, verify via discussions with the Management Representative (or designee) or the review of established procedures, that the firm is aware of its tracking obligations.

Verify that the firm is aware of its obligation to: (1) notify FDA if it goes out of business and provide copies of its tracking records to its FDA District Office; (2) transfer tracking records to a firm purchasing its tracked device(s); and (3) continue tracking a device the firm stops manufacturing or importing if the firm remains in business.

If the firm's tracked device was purchased from another firm, confirm (where applicable) that the firm has obtained and maintains the prior manufacturer's tracking records or equivalent information.

checkmark2. Verify that the firm has established a written standard operating procedure (SOP) for tracking that complies with the requirements in 21 CFR Part 821.25(c).

Review the firm's written tracking SOP(s) and confirm (if possible) that they address the firm's capability to: (1) identify the location and other required data, for tracked devices undistributed to a patient within three working days after a request by FDA, and (2) identify the location and other required data for tracked devices distributed to a patient, within 10 working days after receipt of a request from FDA.

If applicable, select one or two files containing tracking information requested by the FDA and confirm that the appropriate information required by 821.25(a)(1) _ 821.25(a)(3) was provided within the appropriate time-frame(s).

Confirm that the written tracking SOP(s) address the remaining 821.25(a), 821.25(b), and 821.25(c) requirements for the collection, maintenance and auditing of tracking data.

checkmark3. Verify that the firm's quality assurance program includes audits of its tracking system within the appropriate time-frames specified in 21 CFR Part 821.25(c)(3).

Confirm that the audit procedure addresses both the functioning of the tracking system and the accuracy and completeness of the data within the system.

Confirm that the firm has conducted audits of its tracking system at the appropriate time intervals (no less than ev-ery six months for the first three years of tracking and annually thereafter).

mailboxNOTE: The agency's policy relative to the review of quality audit results is stated in CPG 7151.02 (CPG Manual Sub Chapter 130.300). This policy prohibits FDA access to a firm's quality audit results. However, the audit procedures and documents that demonstrate that the audits have been conducted at the appropriate time intervals are subject to FDA inspection.

Page Last Updated: 11/25/2014
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