So, what are the guidance documents and the deadlines to provide feedback to the IMDRF?

WARNING; It is critical to be aware that each comment template is specific to a specific draft guidance document and if you don’t use the proper one your comments could be skipped over or not aligned with the proper guidance document and you would then not have your comments covering what you are commenting on so be careful and double check on the IMDRF website as they may update the documents and this post will not go back and update these links.

First, let’s look at the UDI System for Medical Devices (Version 2.0).  The GHTF issued a version of this guidance back on 16 Spet 2011.  The IMDRF document clarifies and supplements the GHTF document. From the introduction the Guidance document tells us: “This guidance provides a framework for those regulatory authorities that intend to develop their own UDI Systems…In order to reach the goal of a globally harmonized UDI System, it is critical that these systems are implemented without regional or national differences. This guidance is intended to provide a high-level conceptual view of how a global UDI System should work.”  It goes on to say that additional guidance may be needed once the core concepts are implemented.

The Guidance goes on and indicates that there are 7 fundamental concepts of a globally harmonized UDI System and includes:

• the UDI and UDI Carrier are based on global standards
• a UDI applied to a medical device anywhere in the world should be able to be used globally to meet the UDI requirements of any regulatory authority
• national or local identification numbers should NOT be a substitute for UDI
• regulatory Authorities should not specify how to modify these standards
• the UDI Database (UDID) core elements should not be modified
• the UDID should use the HL7 SPL for data submission
• each medical device needs to be identified by a UDI

Comments are due by 31 July 2013.  If you want to submit comments please use either of the comment templates Comments template – DOC (32kb) or  Comments template – PDF (56kb).  They ask that the comments are sent to EC-IMDRF2013-SECRETARIAT@ec.europa.eu.

Let’s look know at the other documents of interest which are a set of 2 documents that are related to the Third Party Audit Process.   These two guidances aim to establish a common set of criteria for medical device auditing and monitoring organizations and the competency of their employees.

The first of the series of two guidance documents we will look at is the draft guidance on Recognition and Monitoring of Organizations undertaking Audits of Medical Device Manufacturers issued on 5 April 2013 with comments being due on 14 June 2013.  The guidance says “IMDRF developed this document to encourage and support global convergence of regulatory systems.”  The document goes on to say that the concept was first addressed by the GHTF and “IMDRF seeks to further the work of the GHTF in this document by providing a common set of criteria to be utilized by the Regulatory Authorities for the recognition and monitoring… of entities that perform audits…”  “The functions covered by an Auditing Organization, within the scope of this document, and roles assigned are described” below:

Functions                                         Audits On-site             Audit/Decision Off-site

Conduct assessment application review       n/a                             Program administrator
to determine audit team competence
required, select the audit team members,
and determine audit duration

Assessment of quality management            Lead Auditor/Auditor    n/a
system

Assessment of product related                    Technical Expert         n/a
technologies

Assessment of Technical Files                   Technical Expert         n/a

Assessment of Regulations                        Lead Auditor/Auditor/   Final Reviewer/
                                                                Technical Expert         Technical Expert

Comments are due by 14 June 2013.  If you want to submit comments please use either of the comment templates Comments template – PDF (31kb) or  Comments template – DOC (54kb).  They ask that the comments are sent to the Medical Device Single Audit Program (MDSAP) Working Group Chair, Ms. Kim Trautman and with a copy to the IMDRF Secretariat.

The second in this series of draft guidance documents is titled Auditor competency and training requirements for organizations undertaking audits of medical device manufacturers.  It was issued on 31 January 2013 with comments due by 14 June 2013. The draft guidance states “The purpose of this document is to specify competency requirements that shall be demonstrated and maintained by recognized Auditing Organization for personnel involved in medical device regulatory audits and decision making.”  The document is “for personnel involved in audits and decision making functions for assessing conformity with regulatory requirements for medical device manufacturers, and includes:

• Defining knowledge, skills, and abilities
• Criteria for various degrees of competency based on roles in audits and decision making functions
• Assisting in evaluation and development
• Providing a basis for identifying training needs

In Addition to this article I have blogged on the topic a couple other times so if you want to see more material (original post) on the topic please continue to read on more of the details and experiences that impact many different people in many different ways (some good and some not so good) on the use of Medical Devices in the Home Use environment and how that impacts the users and their families that use these old and new technologies in the home.  Sometime these devices really are only designed for the hospital setting like some IV pumps, patients may have trouble with them to the point that patients pass away, which is a real tragedy no matter how you look at it.  There are 2 MD&DI articles on the Home Use Draft Guidance and one of the articles deals with an IV pump that probably shouldn’t have been in the home use environment with really sad results.

If you company needs support dealing with the IEC 60601-1-11 standard for Home Use Environment or with the FDA Home Use Draft Guidance document, working with the Safety Agencies or the National Regulatory bodies (US, Canada, Europe, and around the world) for a product submission and approval we can provide you with regulatory, product safety, standards compliance, quality system services and more.  Please feel free to contact us at Leo@EisnerSafetty.com or 503-244-6151.   

Buyer Beware – Nursing Home Use Issue:

The FDA draft guidance says that the Home Use environment doesn’t include the use of a medical device in a “professional healthcare facility” (a defined term in the draft guidance) setting as noted in the definition for a “home use device”.  So, that means if you have a device that is designed only for use in a nursing home environment (a “professional healthcare facility” setting per the FDA’s interpretation) that the FDA won’t consider it to fall under the FDA’s draft guidance document and therefore under IEC 60601-1-11:2010 (1st ed.) which is the standard the FDA draft guidance document mentions exclusively, in terms of medical electrical equipment home use device standard.

I noted that the AAMI version of IEC 60601-1-11 standard which is titled “ANSI/AAMI HA60601-1-11:2011 (IEC 60601-1-11:2010, MOD)” has some US national deviations.  The National Deviation of import is that note 2 of the definition for “Home Healthcare Environment” (sub-clause 3.2) has been changed from saying that a nursing home is considered to be the “Home Healthcare Environment” to be a “professional healthcare facility”.   This spurred me to check the FDA’s List of Recognized Consensus Standards and the standard the FDA has Recognized for this issue is the IEC 60601-1-11:2010 version of the standard and not the AAMI version.  In the FDA’s Recognition it states “While this standard (IEC 60601-1-11:2010) recognizes long term care facilities as home use environment, FDA does not consider long term care facilities to be home use environment.”  This surprised me, somewhat, as the AAMI standard has the exception specifically stated right in the US National Deviations and the FDA’s lead for the Home Healthcare Initiative Mary Brady is one of the two co-chairs for the AAMI version of the standard.  Meaning it is clear to me that the FDA was well aware of the national deviation that ended up in the US National standard ANSI/AAMI HA60601-1-11 whereas it is not in the IEC version of the standard and never could be as it is an international standard and therefore national deviations are not allowed. This implies to me that the FDA made a mistake (dare I say such a thing) and should have referenced the AAMI HA60601-1-11:2011 standard instead of the IEC 60601-1-11:2010 standard in the FDA draft guidance and as the US National Recognized Consensus Standard.

So the current bottom line is this (remember it is a draft guidance so it may change):  If you have a device intended only for the nursing home environment and you go to a Safety Agency (i.e. UL, CSA, Intertek, TÜV SÜD, etc.) for a Safety Certification Mark you may be forced into the Home Use standard under IEC 60601-1-11:2010 unless you point out to the Safety Test House that there is a US deviation under the AAMI version (AAMI HA60601-1-11:2011) which says that Nursing Home Equipment is a professional use device which means the standard wouldn’t apply.  That is only if you are going for the US market only.  If you also want the EU or Canada or another country it is likely you may end up needing to get a Safety Agency Mark to IEC 60601-1-11:2010.  If you do get the Nursing Home Use device Safety Agency certified to IEC 60601-1-11:2010 and you go to the FDA for a pre-market submission (i.e. 510(k)) with this as part of your market clearance test data and you use the FDA draft guidance for home use, as well, you may run into some trouble because now the FDA may say this isn’t a Home Use Device per the draft guidance and so they may ask a lot of questions or they could ask you to rethink your approach and resubmit when you get things straight.

MD&DI Articles:

The two articles are “FDA’s Home Use Draft Guidance: Good But Not Gospel” and the really heat breaking story “How a Bad IV Pump Got into Nancy Stark’s Home”.  I hope these articles give you some perspective on the draft guidance document and I know I will be sending in a comment to the FDA in regard to the Home Use Draft Guidance based on the above “Buyer Beware – Nursing Home Use Issue” so hopefully the FDA can clarify this and make it clearer to the user of the Guidance document and that it links better to the applicable standard.

Related Articles:

FDA on Quest to Standardize Mandatory MedDvc Labeling

FDA Issues Draft Guidance on MedDvcs Intended for Home Use

The Federal Register notice (FR Notice) continues with details about the workshop.  The public workshop is free with registration (please register early) and will be held on April 29 – 30, 2013 at the FDA White Oak Campus at 10903 New Hampshire Ave, Bldg 31 Conference Center, the Great Room (room 1503A), Silver Springs, MD 20993. To register for the workshop visit the FDA’s Medical Devices News & Events – Workshop & Conferences calendar.  There is also an option for a Webcast to view the workshop from off-site web facilities.  To sign-up in this way use the same registration link as above but make sure to note that you want to attend via a webcast vs in person.  The contact person for this workshop is Mary Brady, Mary.Brady@fda.hhs.gov who is also involved with the Home Use Medical Device Initiative so this is a good tie-in with that subject as labeling is critical to get consistent for ease of use or Usability (or Human Factors some call it).  Refer to the blog post on the Home Use Medical Device Draft Guidance document that was issued on 12 December 2012 for details about the Home Use Draft Guidance document and also about the Home Use Initiative.

In the background section of the FR Notice for this Workshop FDA indicates “Currently, there are no regulations that explicitly define and describe a standard content and format for medical device labeling. FDA is concerned that the lack of standard content and format may translate into an increased risk of medical device error. Also, there is no single available source of medical device labeling for people to view, search, and download for devices that are used in clinical and non-clinical environments. FDA is aware of and concerned with the risk of medical errors that result from lost or inaccessible labeling.”

FDA also conducted a 2-phase research study with Research triangle Institute (RTI) of healthcare professionals in regard to their experiences with medical device labeling, and what they would like to see in a standardized version of device labeling. Key findings from the study helped create an outline for standard content and format for medical device labeling id’ing the most relevant sections.  Also, survey participants asked for a “quick reference guide”  for proper device operation & use.  They indicated that would be more convenient and effective with the option of referring to a more comprehensive form of labeling.

Additionally FDA also conducted a survey of the National Family Caregivers Association (NFCA) on medical device labeling to elicit home caregivers’ experiences with medical device labeling for devices used in the home environment.  Here again is another tie-in with the Home Use Medical Device Draft Guidance document and blog post on this subject.  It is clear this initiative is tied-in with the Home Use Initiative and will help support each of the initiatives.  FDA continues to say in the FR Notice “As more medical devices migrate out of clinical care environments and into patients’ homes, the assurance that devices are being used properly and safely no longer resides with a healthcare professional; rather, the responsibility is with the patient, spouse, sibling, or even children. When medical devices are sent home with patients or are moved from one location to another, the labeling often becomes misplaced, lost, damaged, or discarded, which may result in adverse events or other complications due to misinterpretations and absence of proper labeling.”

Per the FDA FR Notice the workshop will focus on the following topics for discussion

A. Summary of FDA Work on Labeling

1. RTI two-phase research study of healthcare professionals regarding device labeling.
2. NFCA survey of consumers on medical device labeling.
3. Cooperative Research and Development Agreement with Kwikpoint for the development of visual language for device labeling.
4. The Center for Drug Evaluation and Research measures of success with standard labeling and the use of a drug repository.

B. Standard Content and Format of Device Labeling

1. Review the outline for a draft standard content and format of medical device labeling.
2. Current thinking on a standard content and format of medical device labeling.
3. Use of symbols in medical device labeling.
4. Discuss a shortened version of standard medical device labeling.

C. Repository of Medical Device Labeling for Home Use Devices

1. Online access to device labeling.
2. Panel discussions on using an online device labeling site.
3. Discuss the types of devices whose labeling should be on the site.

For additional information on the topic also refer to the RAPS News article on 4 Jan 2013.

Back in April 2010 the FDA launched the Medical Device Home Use Initiative as there were concerns of the growing number of safety issues with medical devices intended for professional settings like a hospital being misused in the home setting.  An example is the misuse of infusion pumps intended for the hospital or other professional healthcare environment and not the home use environment. One of the many case studies that the FDA is publishing on a monthly basis was the case of a 9 year old girl using a insulin infusion pump set that was discarded from the hospital with an infusion pump.  Soon after using the infusion pump set she had nausea and vomiting and ended up in the emergency room.  When the medical professional removed the cannula it became apparent that it was bent and sadly the infusion pump didn’t alarm or notice the change.  The next day she died due to heart failure.  The case study on the FDA website is not clear if there is a direct connection to her death and the fact that the infusion pump didn’t alarm but you can see that the use of an infusion pump and the infusion pump set being improperly handled and maybe even the infusion pump wasn’t set-up properly caused some major issues at a minimum.

This initiative through FDA’s efforts have provided additional information and resources for manufacturers, health care professionals, home care recipients, consumers, and caregivers and FDA is continuing to develop and encourage the safe use of home use medical devices.  The key areas of this Initiative are 1) the issuance of a draft guidance document (just released and that is what this post is all about) for manufacturers recommending actions they should take to receive FDA approval or clearance of devices intended to be used in the home, 2) develop a labeling repository for medical devices that have been approved or cleared for home use (they are still working thru this issue and seeing if this will be a feasible solution), 3) Increasing Public awareness of the situation of use of medical devices outside the clinical setting.

To ensure that the FDA considers your comments on this draft guidance before the FDA begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by March 13, 2013.

The draft guidance document is a big step in the right direction as the home use environment is a very different environment than is the hospital or clinic setting where the medical devices used in those settings are controlled and operated primarily by the Dr’s, nurses or other clinicians. Whereas, outside those controlled environments (i.e. hospitals & clinics) medical devices many times are operated by a lay person (user with no professional training or experience) and so there are considerable risks that need to be considered which this FDA draft guidance document attempts to consider. The guidance document considers both OTC (over-the-counter) and prescription devices, the use environment (locations being used such as at home, in the shower, at the tennis court, out shopping, on a train or bus, on an airplane, at the beach, out for a run, etc.), and the discusses different unique risks. “The draft guidance provides recommendations for minimizing the risks associated with home use devices by considering the user, the use environment, the device or system, human factors, and labeling.” The guidance says that the recommendations apply to design and development of the device but also provides recommendations regarding postmarket considerations and lastly that the design & development recommendations should be considered even if the device that is likely to used in the home even if the device isn’t intended solely for home use.

The guidance does differ from IEC 60601-1-11 (medical electrical devices for use in the home use environment) a bit in the definitions as the guidance says that:

A home use device is a medical device intended for users in any environment outside of a professional healthcare facility or clinical laboratory. The term includes devices intended for use in both professional healthcare facilities and homes.

A professional healthcare facility is an environment where operators with medical training are continually available to use devices when patients are present. This includes but is not limited to hospitals, long-term care facilities, nursing homes, emergency medical services, clinics, and outpatient treatment facilities.

A qualified healthcare professional is a licensed or non-licensed healthcare professional with sufficient skills and experience with the use of a device to aid or train someone to use and maintain the device.

A home is any environment other than a professional healthcare facility or clinical laboratory where a device may be used.

Whereas, in the IEC 60601-1-11:2010 standard the following definitions mean that the Nursing Homes are considered to be a Home Healthcare Environment which is in conflict of the FDA draft guidance document which doesn’t include it in their definition as a “Home Use” Environment.

Home Healthcare Environment (clause 3.2) is a dwelling place in which a Patient lives or other places where Patients are present, excluding professional healthcare facility environments where Operators with medical training are continually available when Patients are present

Within this same definition (clause 3.2 of IEC 60601-1-11) there are a couple notes that clearly state what a Professional Healthcare Facility is including environments such as a hospital, clinic, Dr’s offices, free standing surgi-centers, dentist offices, free standing birthing centers BUT doesn’t include Nursing Homes as a Professional Healthcare Facility.  This is where the FDA guidance document and IEC 60601-1-11 differ and this is surprising to me as the FDA guidance document does refer directly to IEC 60601-1-11 in seven cases in the guidance document so they are relying on it for some of the basis of the guidance document.

Design controls are called out in several ways in the guidance document including use of Design Controls per 21CFR820.30 which if you have an FDA QS (Quality System) per the QSR (Quality System Regulation) this should be included in your QS if you design products.  Also, it discusses as part of the Design Controls the use of the Risk Management Process per ISO 14971 with some additional inputs to the risk management process including from Human Factors / Usability Engineering Analysis per AAMI HE74 (Human Factors Design Process for Medical Devices), AAMI HE 75 (Human Factors Engineering – Design of Medical Devices), and IEC 62366 (Application of usability engineering to medical devices).  Lastly, this section of the guidance also discusses that software should be controlled thru the Design Control process and that IEC 62304 (medical device software – Software lifecycle processes) as well a couple FDA Guidance documents on Software are important to consider, as applicable to your home use device.  This means that you, the manufacturer, will need to per the FDA guidance document “broaden your existing concept development and preliminary testing processes to account for the needs of home users and requirements for straightforward device operation, obvious interface layouts, and appropriate alarm methods.”  As you can see Design Controls will be important to follow the FDA Recognized Consensus Standards (ISO 14971, IEC 62366, IEC 62304, & AAMI HE75 but HE74 isn’t an FDA Recognized Consensus Standard) and the applicable FDA Guidance documents, as well.

Now, let’s look at Environmental Considerations a bit more – As I mentioned earlier in this post there are many locations to consider.  The guidance document in section 3, “Environmental Considerations”, refers the reader directly to IEC 60601-1-11:2010 (1st edition), it also indicates that you should label the device to include warnings against using the device in environmental conditions which would raise safety & effectiveness concerns but never label to mitigate risks (very similar tone as from the EU Commission in regard to all 3 Medical Device Directives). The main environmental considerations this section of the document covers the following environmental considerations:

•  Location – Such as urban, suburban, rural, school, office, retail, trains, planes, cars.   How does the applicable environments to your device impacts the patient, the device,  and the environment around the device?  What’s the impact on the device from Electromagnetic Interference (EMI)?
• Physical Location – Consider the structure of the location(s) the device will be used in. What about a crowed location such as a small apartment with lots of stuff around that the patient may bump into on a regular basis?  Are there any hazards because of the crowded environment, such as tripping hazards, device cables getting tangled, device getting bumped, etc.
• Contaminants – Consider the environment a non-sterile location.  Consider the risks that your device or the location of it’s use could be contaminated with such things as smoke, pet hair, household chemicals, etc. Design the product to prevent ingress of liquids and particulates.  Refer to IEC 60601-1-11 as these are some of the considerations within the standard.
• Water supply, if applicable to the device – type of water – distilled vs well or tap water – An example would be the impact if a CPAP machine used tap water vs distilled water there is a lot of mineral deposits that end up on the water chamber which means some of that could be breathed in by the patient.  So, is this a hazard?  Something for the manufacturers to figure out.
• Temperature – There could be a variation in temperature within a home that doesn’t have air conditioning, what if the device is portable and left in the car on a really hot day or on a snowy day?
• Dampness & humidity – Similar considerations to Temperature.
• Atmospheric pressure changes –  Elevation and plane travel have impact on this issue.
• Air-flow – Blocked air vent can be an issue in this case if your device relies on ait-flow.
• Child-proofing – Since the device will be in the home and many homes have children or children visitors the devices should be child-proofed (avoid small parts being accessible, minimize number of detachable parts, etc.).
• Tamper-proof – Intentional and no-intentional.
• Travel & International Use – Local, regional, international.  This means change in power source voltage, current & frequency are all possible which could have impact on the functioning of the device.  There could be need for a battery back-up and labeling to deal with identifying what power adaptor would be sufficient to work for what country of use.  Some countries such as Japan depending on what part of the country you are located in you have either 50 or 60 Hz, but only 100Volts (differs from the typical 120 VAC in the US).  Interpower Corp has a great resource if you are looking to know what is the voltage and frequency for each country and also the power plug type.  This chart by Interpower is something I refer to on occasion but I can see many of my clients using this document.
  Also, consider traveller passing thru security checkpoints and how that impacts the patient of body-worn devices and the impact of the x-ray or other screening technologies (now and in the future) impact on the device itself. Or if the user must under go a “pat-down” The guidance points the user of this guidance to the TSA website for information to consider being added to the user’s manual.
• Fluid Exposure – Fluid spills and submersion of fluids.  This is also considered in IEC 60601-1-11.

The guidance goes on to “User Considerations” for section 4 of the document.  The user in this case is not the same as the Health Care professional that uses devices in the hospital, clinic, dr’s office, out-patient surgi-center, nursing home, and other professional health care facility.  Home users can have a wide range of disabilities that the device maker will need to consider in the design of the device including physical, sensory/perceptual, cognitive, emotional capabilities and disabilities.  So, you need to make the device as easy as possible as can be used and you need to consider and use some if not all of the documents that FDA recommends in this section which includes: FDA guidance on Human Factors (issued july 2000 – dated compared to the next few standards noted here), IEC 62366:2007, AAMI HE75:2009, IEC 60601-1-11:2010.

Section 5 goes into “Device Considerations” which the FDA means to keep it simple (or the KISS concept – Keep It Simple Stupid) to understand, operate, and maintain safely & effectively.  FDA provides some device – specific considerations that the device maker should consider in their design and development of the device(s) at hand such as:

• Lock-out mechanisms – to avoid access to certain functions that the health care provider may need to set.
• Calibration – avoid calibration if possible and if not minimal calibration by the user (make sure to have very clear step by step instructions & clear feedback while doing any calibration steps).
• Mechanical Strength – Refer to IEC 60601-1-11 for mechanical tests of both transit operable and non-transit operable devices.
• Electrical Issues – Supply mains (power source tests per IEC 60601-1 – interruption, voltage limitations); Internal electrical power source (i.e. batteries – charging issues, IFU details, replaceable batteries); Permanently installed devices (grounding issues); Outlets and Adaptors (can the device share power with another device?, can you connect device to an outlet that is connected to a switch?, etc.); Power outages (back-up power considerations, emergency contact info, how long or how many cycles can the device operate without mains power?, etc.); Battery life (how long operate on a fully charged battery?)
• EMC (Electro-magnetic compatibility) – Refer to the FDA Recognized Consensus Standard IEC 60601-1-2:2007 Medical Electrical Equipment, Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.  This standard considers tests for immunity of the device to the outside world and emissions from the device to the outside (it’s impact on other things and devices).
• Wireless Technology – Manufacturer will need to meet applicable technology standards (none mentioned in the document), FCC requirements.  Safety & effectiveness concerns of the wireless technology will be an important point to highlight and prove to the FDA.
• Alarm Systems – FDA recommends to follow IEC 60601-1-8:2006 (2nd edition) – Medical electrical equipment; Part 1-8: General requirements for basic safety and essential performance; Collateral Standard: General requirements, tests and guidance for alarm systems in medial electrical equipment and medical electrical systems.

Section six discusses “Human Factors” including User Training, Certification and the FDA guidance documents and standards such as ISO 14971:2007 (Risk Management for Medical Devices), IEC 62366:2007 (mentioned earlier in this post) and AAMI HE75:2009 (mentioned earlier in the post).

Section seven discusses “Labeling” at length including the FDA requirements under 21CFR Part 801 (Labeling) & 809.10 (Labeling for in vitro diagnostic products); FDA guidance document on Patient Labeling (Issued April 2001); 6 other FDA guidance documents; IEC 60601-1-11:2010, section 7.5.2; ISO 15197 First edition 2003-05-01, In vitro diagnostic test systems – Requirements for blood-glucose monitoring system for self-testing in managing diabetes mellitus, Clause 5; a booklet that FDA put together for the Home User of the Device – titled “How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity”; a reference to the Department of Homeland Security for “Prepare for Emergencies Now”;  the FDA webpage titled “FDA Offers Tips about Medical Devices and Hurricane Disasters”; a reference to the EPA (Environmental Protection Agency) website in how to properly dispose of medical waste focused on state programs and regulations;  and references to IEC 60601-1-2:2007.  I am disappointed the guidance doesn’t refer to other sections of IEC 60601-1-11:2010 as there are other important areas to consider for marking & labeling from both IEC 60601-1:2005 (or AAMI ES 60601-1:2005) in clause 7 and also in IEC 60601-1-11:2010 in clause 7.

Section 8 goes into “Postmarket Considerations” including Customer Service, Medical Device Reporting and Selling or Purchasing Used Prescription Devices.

Section 9 is the conclusion section of the document pointing at that if you follow this document in the design and development of your device you have a higher likelihood of a safe and effective device.

Section 10 is a listing of additional resources to consider while you are on this journey of designing a safe and effective home use device.