SHA: Solid Wound Dressing With Permanently Bound Antimicrobial Agent

FDA product code SHA. Class II, classified under 21 CFR 878.4013. What the classification flags say about Part 820 under the QMSR.

Classification

Product code: SHA
Device name: Solid Wound Dressing With Permanently Bound Antimicrobial Agent
Device class: Class II
Regulation: 21 CFR 878.4013
Review panel: General, Plastic Surgery
Premarket route: 510(k)
CGMP-exempt flag: No
Life-sustaining flag: No
Implant flag: No
Third-party review: Not a candidate
Summary malfunction reporting: Ineligible

FDA definition. A solid wound dressing with permanently bound antimicrobial agent consists of a solid wound dressing containing antimicrobial permanently bound to the substrate surface. The solid wound dressing is used to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound and is intended for use only on external cutaneous (skin) wounds. The solid wound dressing is provided sterile in a form able to hold structural integrity. Antimicrobials are used for protectant purposes only to reduce microbial growth within the solid wound dressing while in use, or to provide an antimicrobial barrier to microbial penetration through the solid wound dressing. This classification does not include solid wound dressings containing a medically important antimicrobial as defined in the special controls.

Data from openFDA as of 26 October 2026. Read the record on openFDA · FDA product code classification database

Part 820 requirements the flags point to

Part 820 rules for SHA

CGMP exemptionClassification regulation, 21 CFR parts 862 to 892: Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
Design and development, ISO 13485 clause 7.321 CFR 820.10(c): Rule names this classRule names Class II.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.21 CFR 820.10
Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d): Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
Complaint and record content21 CFR 820.35: Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions

These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.

Clearances and recalls on record

510(k), De Novo and BK numbers linked: 1 · Search these clearances
PMA numbers linked: 0
Recall product records: 0
Adverse event reports: Search MAUDE for SHA

Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.

Search all 7,097 product codes, or read the guide to the Part 820 rules behind these flags.

Check your quality documents against Part 820

Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.