OTT: Research Use Only/Microbiology

FDA product code OTT. Not classified. What the classification flags say about Part 820 under the QMSR.

Classification

Product code: OTT
Device name: Research Use Only/Microbiology
Device class: Not classified (reason: enforcement discretion)
Regulation: FDA lists no classification regulation for this code
Review panel: Microbiology
Premarket route: Enforcement discretion
CGMP-exempt flag: Yes
Life-sustaining flag: No
Implant flag: No
Third-party review: Not a candidate
Summary malfunction reporting: Eligible

FDA definition. For research use only and for products imported into the US only.

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 OTT

CGMP exemptionClassification regulation, 21 CFR parts 862 to 892: Database cannot sayFDA flags this code as exempt and lists no classification regulation.With no regulation number there is no exemption text to read. The flag alone does not say which Part 820 requirements are lifted.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
Design and development, ISO 13485 clause 7.321 CFR 820.10(c): Database cannot sayFDA lists this code as not classified.820.10(c) names class I, II and III devices. The database holds none of those for this code, so it cannot say whether clause 7.3 applies.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: 0
PMA numbers linked: 0
Recall product records: 1
Adverse event reports: Search MAUDE for OTT

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.