However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. This guidance is issued in conjunction with a Federal Register notice announcing the classification of remote medication management systems.įollowing the effective date of a final rule, manufacturers of remote medication management systems will need to address the issues covered in this special control guidance. The system is intended for use as an aid to healthcare professionals in managing therapeutic regimens for patients in the home or clinic.
4 ELEMENTS II SPECIAL EDITION LEVEL PROFESSIONAL
The device is intended to provide a means for a patient's prescribed medications to be stored in a delivery unit to permit a healthcare professional to remotely schedule a patient's prescribed medications to provide notification to a patient when the prescribed medications are due to be taken to release the prescribed medications to a tray of the delivery unit accessible to a patient on the patient's command and to provide to the healthcare professional a history of the event.
This guidance document was developed as a special control guidance to support the classification of the remote medication management system into class II (special controls).
4 ELEMENTS II SPECIAL EDITION LEVEL VERIFICATION
Verification of the Current Inventory of Medications.Selection and Delivery of the Medication.The Content and Format of an Abbreviated 510(k) Submission.Please use the document number (1621) to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance.
Additional CopiesĪdditional copies are available from the Internet. Comments may not be acted upon by the Agency until the document is next revised or updated. Please identify your comments with the docket number listed in the notice of availability that publishes in the Federal Register announcing the availability of this guidance document. Alternatively, electronic comments may be submitted to. Written comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Richard Chapman at 30 or by e-mail Department of Health and Human ServicesĬenter for Devices and Radiological Healthĭivision of Anesthesiology, General Hospital, For questions regarding this document contact Mr.
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