Last week I wrote about mHealth technology and FDA regulation and the murkiness of such regulation. Finally, the FDA has released a set of proposed guidelines, of what mobile apps will be subject to FDA regulation. They include:
· Mobile apps that are an extension of a medical device by connecting to the device for purposes of controlling the device or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communication System (PACS) server, apps that provide the ability to control inflation and deflation of a blood pressure cuff , apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.
· Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Examples include attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform (e.g., cell phone) to function as a glucose meter, or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals.
· Mobile apps that allow the user to input patient-specific information and output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions (Offer suggestions about a patient's diagnosis or treatment). Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, calculate dosage for a specific medication, or provide clinical recommendations that aid a clinician in making a diagnosis or selecting a specific treatment.
People have up to 90 days from publication of the proposed guidelines to submit comments and suggestions.
Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm#5
>>what mobile apps will be subject to FDA regulation<<
ReplyDeleteSo I'm reading over how or what the FDA plans to regulate, and how. So here's the list...
Class I devices: General Controls, including:
--Establishment registration, and Medical Device listing (21 CFR Part 807);
--Quality System (QS) regulation (21 CFR Part 820);
--Labeling requirements (21 CFR Part 801);
--Medical Device Reporting (21CFR Part 803);
--Premarket notification (21CFR Part 807);
--Reporting Corrections and Removals (21 CFR Part 806); and
--Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812)
Class II devices: General Controls, Special Controls, and (for most Class II devices) Premarket Notification
Class III devices: General Controls and Premarket Approval (21 CFR Part 814)
...and I'm wondering how much do all these individual regulations cost? What are the penalties for noncompliance? If a company IS fully compliant and a patient is still dissatisfied with the performance of the relevant mobile hardware or app, are they still liable in civil or criminal court?
Food for thought.
/b
The penalties for noncompliance are having the device removed from the market which can be a huge blow to the manufacturer. The manufacturer would only be liable if some harm was caused to the patient by using their device.
ReplyDelete