1. 2010.12.101martine4@gmail.com The Medical Device Pathway as a Legal Onramp for Futuristic Persons THE FUTURE T HE M EDICAL D EVICE P ATHWAY AS A L EGAL O NRAMP FOR F UTURISTIC P ERSONS Terasem Martine Rothblatt Terasem’s 6 th Annual Colloquium On the Law of Futuristic Persons

2. The FDA rules pertaining to medical devices As found within the Code of Federal regulations at: 21 CFR 800 to 1299 and within the Center for Devices and Radiological Health (CDRH) division of the FDA responsible for medical device regulation; When distributed in the United Sates, subject to General Controls, pre-marketing and post marketing regulatory controls include: A) Establishment Registration by manufacturers, distributors, repackages and re-labelers; B) Medical Device Listing with FDA of devices to be marketed; C) Manufacturing the devices in accordance with Good Manufacturing Practices; D) Labeling medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809; and E) Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medial device. 12/10/10 Martine4@gmail.com 3

3. 12/10/10Martine4@gmail.com3 To what extent are medical nanobots medical devices? Section 201(h) defines a medical device as "an instrument, apparatus, implement, machine, contrivance…intended for use in the … cure, mitigation, treatment, or prevention of disease, in man or other animals… and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” http://kentonspi.blogspot.com/2008/04/nano-technology-nanomagnet-system-could.html Nanorobots the bloodstream

4. FDA medical device classification There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III, assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. The FDA classification of medical devices is based upon classifications for devices currently legally marketed in the United States. New medical devices are compared to legally marketed medical device classifications with the same intended use and technological characteristics to determine the device classification. 12/10/10 Martine4@gmail.com 4

5. CFR medical device classification Class I medical devices have the least amount of regulatory control, present minimal potential harm to the user, are typically simple in design manufacture and have a history of safe use. Class II devices typically require pre-market notification by submission and FDA review of a 510(k)* clearance to market submission. Class III devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient and require a Pre-Market Approval (PMA) submission to the FDA prior to marketing. 12/10/10 Martine4@gmail.com 5

6. 12/10/10Martine4@gmail.com6 Medical Devices Class l Medical Device Low risk to patient http://unimaxsupply.com/md/1tong.htm Class ll Medical Devices Medium risk to patient http://www.reference.com/browse/x-ray Class III Medical Device Synthetic heart valves http://healthguide.howstuffworks.com/heart-valve-surgery-picture.htm Class III Medical Device Implanted nerve stimulator High risk to patient http://emedicine.medscape.com/article/1681045-overview

7. 12/10/10Martine4@gmail.com7 What FDA Requirement would pertain to medical nanobots used on a legally dead ? If the nanobot revived the human body, then the body would be alive in which case it would be a medical device. The nanobot would not be able to go through 510(k) since it is a novel technology and there are no available predicates. The nanobot would likely be a PMA device, which would require a clinical study to demonstrate safety and effectiveness.

8. 12/10/10Martine4@gmail.com8 Is a robot into which a biological mind has been digitized and uploaded a medical device? A robot, such as the Bina48, would not be considered a medical device because it is not used in or on the human body. Very similar to computer modeling, i.e. creating a simulated environment that mimics the human body/mind and that can be used to validate the functions of devices on the human body/mind. Such computer models are not regulated by the FDA. But, if the model were to be used for testing of devices that would be used on humans in the future, it would be beneficial to have the model validated by the FDA for such use. BINA48

9. 12/10/10Martine4@gmail.com9 What rules to ensure that uploaded minds running on medical devices are safe and effective and not inhumane, tortuous, painful or inaccurate? The question of whether the device is "inhumane, tortuous, painful or inaccurate" would be established through progressive clinical trials and investigational review board (IRB) approvals. The endpoints to be measured and the protocol for such trials would be established in advance through a pre-IDE meetings with FDA or similar and meetings with IRBs and professional groups.

10. 12/10/10Martine4@gmail.com10 Thank you