The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The FDA has identified a subset of medical devices that pose a greater likelihood of microbial transmission and represent a high risk of infection (subclinical or clinical) if they are not adequately reprocessed. This identification was based on knowledge gleaned through MDRs; recalls; periodic outbreaks of microbial transmission or patient infections reported in the literature or media; reports provided by the Centers for Disease Control (CDC), the Veterans Administration (VA), and other health care settings; and manufacturer-initiated surveillance studies.
Reprocessing instructions for medical devices should be validated. However, because of the greater risks to the public health posed by the devices listed below, 510(k) submissions for these devices should include protocols and complete test reports of the validation of the reprocessing instructions so that FDA has the information it needs to evaluate substantial equivalence. This includes validation of the cleaning instructions as well as the disinfection or sterilization instructions. The reprocessing validation data should demonstrate that the proposed reprocessing instructions will reprocess the subject device at least as well as the reprocessing instructions for the predicate device. The devices identified by FDA as within this subset are listed as follows:
Bronchoscopes (flexible and rigid) and accessories
Ear, Nose, and Throat (ENT) endoscopes and accessories
Product Code
Device Name
Regulation Number
EOX
Esophagoscope (flexible or rigid)
874.4710
GCL
Esophagoscope, general & plastic surgery
876.1500
FDW
Esophagoscope, rigid, gastro-urology
876.1500
EOB
Nasopharyngoscope (flexible or rigid)
874.4760
EQN
Laryngoscope, nasopharyngoscope
874.4760
EWY
Mediastinoscope, surgical, and accessories
874.4720
Gastroenterology and Urology Endoscopes* that have elevator channels (not including accessories) [e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)]
* For endoscopes that fall under the product codes above, 510(k) submissions should include reprocessing validation data for those endoscopes designed with elevator channels.
Automated Endoscope Reprocessors (AERs)
Product Code
Device Name
Regulation Number
FEB
Accessories, cleaning, for endoscopes
21 CFR 876.1500
NZA
Accessories, germicide, cleaning, for endoscopes
21 CFR 876.1500
KOG
Endoscope and/or accessories
21 CFR 876.1500
OUJ
High level disinfection reprocessing instrument for ultrasonic transducers
21 CFR 892.1570
Colonoscopes (not including accessories)
Product Code
Device Name
Regulation Number
FDF
Colonoscope and accessories, flexible/rigid
876.1500
FDA
Enteroscope and accessories
876.1500
Neurological endoscopes (not including accessories)
**For laparoscopic instruments and accessories that fall under the product codes above, premarket review of reprocessing validation data is only necessary for those with design features given in Table 1 below.
Laparoscopic instruments and accessories**
Table 1 510(k) Submissions Should Include Reprocessing Validation Data for Laparoscopic Instruments and Accessories with Any of the Following Design Features
Lumens (with internal surfaces that are not smooth, have internal ridges or sharp angles, or are too small to permit a brush to pass through)
Hinges
Interior device channels
Sleeves surrounding rods, blades, activators, inserters, etc.
Adjacent device surfaces between which debris can be forced or caught during use
O-rings
Devices with these or other design features that cannot be disassembled for reprocessing
Stopcocks
In the future this list may be updated as additional information regarding reprocessing medical devices becomes available.
