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PART 1--IN GENERAL (0)

SEC. 2561. NATIONAL MEDICAL DEVICE REGISTRY.

‘National Medical Device Registry

‘(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that--

‘(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for--

‘(3)(A) To facilitate analyses of postmarket safety and patient outcomes for devices described in paragraph (1), the Secretary shall, in collaboration with public, academic, and private entities, develop methods to--

‘(B) In this paragraph, the term ‘data’ refers to information respecting a device described in paragraph (1), including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.

‘(4) Not later than 36 months after the date of the enactment of this subsection, the Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations--

‘(5) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for fiscal years 2010 and 2011.’.

(b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers-

(1) RECOMMENDATIONS- The HIT Policy Committee established under section 3002 of the Public Health Service Act (42 U.S.C. 300jj-12) shall recommend to the head of the Office of the National Coordinator for Health Information Technology standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in section 519(g)(1) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).

(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of the Health Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.



What is a Class II device that is implantable?

[highlights/underscoring by The M+G+R Foundation]

Looking for what is a class II device that is implantable, as stated in the section 2561 (g) (1) (B) (ii), the classification of this device as a Class II is at 21 CFR 880.6300 (as determined on December 10, 2004) I found the following (1)

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information. See 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 880.9.
 
And the document that gives the guidance for Class II devices (dated also December 10, 2004) is titled: Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information. (2)
 
In said document it is said:
 
"This guidance document was developed as a special control guidance to support the classification of the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The device is intended to enable access to secure patient identification and corresponding health information in humans. This guidance is issued in conjunction with a Federal Register notice announcing the classification of implantable radiofrequency transponder system for patient identification and health information."

"The scope of this document is limited to the following device as described in 21 CFR 880.6300 Implantable Radiofrequency Transponder System for Patient Identification and Health Information (product code: NRV):

An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code which is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database."
 
The document identify the risks to health generally associated with the use of the Implantable Radiofrequency Transponder System for Patient Identification and Health Information .  It also contains the FDA' recommendations as measures to mitigate the identified risks, as showed in a table and textually.
 
With respect to Verichip (now PositiveID) (3):
 
"In accordance with section 513(f)(1) of the act, FDA issued a document on July 22, 2004, classifying the VERICHIP Health Information Microtransponder System in class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On August 4, 2004, Digital Angel Corp. submitted a petition requesting classification of the VERICHIP Health Information Microtransponder System under section 513(f)(2) of the act.

The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with section 513(f)(2) of the act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the act. Devices are to be classified into class II if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the VERICHIP Health Information Microtransponder System can be classified in class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of safety and effectiveness of the device."
 
There is a letter (dated Oct. 12, 2004) where FDA accepts the reclassification of Verichip. (4)
 
It appears (from the context of the letter) that the production of the Class II Special Controls Guidance Document (supra) was a response to the reclassification application of verichip (21 CFR 880.6300 which is dated December 10, 2004).  In this document (about the reclassification) there is the following statement (bolding and underline mine): 

"Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device.

FDA has determined premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of an Implantable Radiofrequency Transponder System for Patient Identification and Health Information and, therefore, the device type is exempt from the premarket notification requirements.

Thus, persons who intend to market this device type need not submit to FDA a premarket notification submission containing information on an Implantable Radiofrequency Transponder System for Patient Identification and Health Information, unless they exceed the limitations on exemptions in 21 CFR 880.9 (5) (e.g., different intended use or fundamental scientific technology)."
 

The exemptions are just for avoiding a premarket notification submission, and not for avoidance of the interestatal post market of a device. That is, if a different intended use is desire they are needed to make the notification submission. The health law, section 2561 (g) (2) (C) (iii), states that the Secretary shall integrate the activities described in this subsection with:

‘(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter.
 
About the combination of Steal Vault and Verichip (PositiveID), as stated by CEO Scott R. Silverman in a quote in a press release, he sees the medical and credit aspects of his business as two sides of the same coin:

In addition to helping consumers protect themselves from identity theft as it pertains to credit fraud, we are also focused on combating the growing problem of medical identity theft, which affects 7 percent of identity theft victims. Through our secure personal health record, Health Link, which is interoperable with Microsoft Health Vault and soon-to-be with Google Health, we put consumers in charge of their own health information through a robust, patient-controlled interface. (6)        
    
The promotion slide show of the company is quite interesting. (7)
      
Medical identity theft and Social Security number theft (medicare program) are examples of postmarket device surveillance activity which are in the scope of the Secretary of Health.

Downloaded/Read on April 6, 2010_____________________________

(0) http://www.opencongress.org/bill/111-h3200/text  
(1) http://edocket.access.gpo.gov/cfr_2006/aprqtr/pdf/21cfr880.6350.pdf
(2) http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072191.pdf
(3) http://gangologist.com/?p=91
(4) http://www.antichips.com/verichip-fda-letter.pdf
(5) http://cfr.vlex.com/vid/880-9-limitations-exemptions-510-cosmetic-19715369
(6) http://industry.bnet.com/pharma/10007567/positiveids-latest-human-chip-implant-scare-story-medical-identity-theft/
(7) http://i.bnet.com/blogs/positive_id_sept_2009_rodm_conference_final.pdf?tag=content;selector-perfector



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