Contains Nonbinding Recommendations 
Manufacturers Sharing Patient-
Specific Information from Medical 
Devices with Patients Upon Request 
Guidance for Industry and  
Food and Drug Administration Staff  
 
Document issued on October 30, 2017.  
The draft of this document was issued on June 10, 2016. 
For questions about this document, contact the Office of the Center Director at (301) 796-6900.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
  Contains Nonbinding Recommendations 
 
 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2016-D-1264. Comments may not be 
acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 1500067 to identify the guidance you are requesting. 
  Contains Nonbinding Recommendations 
Manufacturers Sharing Patient-
Specific Information from Medical 
Devices with Patients Upon Request 
Guidance for Industry and  
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page.  
I.  Introduction 
The Food and Drug Administration (FDA or we) developed this guidance to clarify our 
position regarding manufacturers appropriately and responsibly sharing patient-specific 
information  information unique to an individual patient or unique to that patients 
treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived 
from a legally marketed medical device  with that patient at that patients request.  This 
guidance provides information and recommendations to industry, healthcare providers, and 
FDA staff about the mechanisms and considerations for device manufacturers sharing such 
information with individual patients when they request it. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidance means that 
something is suggested or recommended, but not required.    
II.  Background 
Increasingly, patients seek to play an active role in their own healthcare.  FDA is aware that 
sometimes a patient will request that a manufacturer share with her information about herself 
that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed 
medical device.  FDA is issuing this guidance to clarify our position regarding manufacturers 
appropriately and responsibly sharing patient-specific information  information unique to 
  1  Contains Nonbinding Recommendations 
an individual patient or unique to that patients treatment or diagnosis that has been recorded, 
stored, processed, retrieved, and/or derived from a legally marketed medical device  with 
that patient at that patients request.  FDA believes that sharing patient-specific 
information with patients upon their request may assist them in being more engaged with 
their healthcare providers in making sound medical decisions.   
III.  Scope 
For purposes of this guidance, patient-specific information is information unique to an 
individual patient or unique to that patients treatment or diagnosis that has been recorded, 
stored, processed, retrieved, and/or derived from a legally marketed medical device.  This 
information may include, but is not limited to, recorded patient data, device usage/output 
statistics, healthcare provider inputs, incidence of alarms, and/or records of device 
malfunctions or failures.  For the purposes of this guidance, patient-specific information does 
not include any interpretations of data by the manufacturer aside from those interpretations of 
data normally reported by the device to the patient or the patients healthcare provider.  For 
example, results of individual component tests for specific analytes that comprise or are 
utilized in a cleared assay but have not been individually approved or cleared to test for those 
specific analytes are not patient-specific information for purposes of this guidance and so 
fall outside the scope of the guidance.  
Generally, categories of patient-specific information may include, but are not limited to: (1) 
data a healthcare provider inputs in the device to record the status and ongoing treatment of 
an individual patient or (2) information stored by the device to record usage, alarms, or 
outputs (e.g., pulse oximetry data, heart electrical activity, and rhythms as monitored by a 
pacemaker).  Patient-specific case logs entered into a medical device by a healthcare provider 
may be included under this definition.  This information may be used to facilitate continuity 
of care, to create an adequate patient treatment history and current treatment profile, and to 
record information relating to medical device functionality.   
IV.  Patient-Specific Information Sharing Policy  
In many cases, patient-specific information from a medical device is accessible by the 
patients healthcare provider and patients can contact their healthcare provider to obtain such 
information.  Alternatively, patients may contact the manufacturer directly and request access 
to their patient-specific information.  In general, although not required under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), manufacturers may share patient-specific 
information about a patient with that patient at that patients request. In general, 
manufacturers may do so without undergoing additional premarket review in advance. FDA 
generally would not consider patient-specific information to be labeling, as defined in 
section 201(m) of the FD&C Act.  FDA is aware that when manufacturers share patient-
specific information with patients, manufacuters also may provide them with supplemental 
information or other materials (e.g., descriptions of intended use, benefit and risk 
information, instructions for use) that may be considered labeling.  Any labeling is subject to 
applicable requirements in the FD&C Act and FDA regulations.     
  2  Contains Nonbinding Recommendations 
We are aware that some devices are designed to record or transmit information in a format 
that is not easily provided to the patient.  Other devices record and retain information in a 
closed system that is not accessible by the manufacturer.   In such circumstances, it may not 
be feasible for manufacturers to share patient-specific information with patients as doing so 
would require manufacturers to redesign devices or gain access to information they do not 
have.   
Generally, if patient-specific information is shared with patients by manufacturers, it should 
be comprehensive and contemporary.  For example, if a patient requests from a manufacturer 
a history of her own blood pressure measurements from a device, the data should include all 
available data up through the most recent measurement.  Manufacturers may also format the 
patient-specific information to facilitate its usability by the patient.   
FDA recognizes the important role healthcare providers play in providing interpretation of 
and context to patient-specific information.  FDA recommends that manufacturers advise 
patients to contact their healthcare providers should they have any questions about their 
patient-specific information.   
Finally, this guidance does not affect any federal, state or local laws or regulations, such as  
the Health Insurance Portability and Accountability Act (HIPAA) (42 U.S.C.  300gg; 29 
U.S.C. 1811 et seq.; 42 U.S.C.  1320d et seq.) and the associated HIPAA Privacy Rule (45 
CFR Part 160 and Subparts A and E of Part 164), which may otherwise be applicable to the 
provision of patient-specific information.  Moreover, the guidance does not change FDAs 
policy and is not intended to supersede any other relevant policies and guidances regarding 
manufacturers communications about their devices.    
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