Product Classification

• Device: dvd, bluray, or hd recorder
• Definition: A dvd, bluray, or hd recorder machine that utilizes a laser to read and write or read, write, and erase data on a digitally recorded video disc in any of the data formats: Dvd-r, dvd+r, dvd-ram, dvd-rw, or dvd+rw, or bluray or hd recorders or read/writers.
• Product Code: RFY
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: Yes

    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

• Summary Malfunction Reporting: Ineligible

Third Party Review

Not Third Party Eligible