A Guest Document

(a) Registry- CommentsClose CommentsPermalink

‘(A) is or has been used in or on a patient; and CommentsClose CommentsPermalink

‘(B) is-- CommentsClose CommentsPermalink

‘(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each device described in paragraph (1) by type, model, and serial number or other unique identifier; CommentsClose CommentsPermalink

‘(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of-- CommentsClose CommentsPermalink

‘(C) integrating the activities described in this subsection with-- CommentsClose CommentsPermalink

‘(D) providing public access to the data and analysis collected or developed through the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists. CommentsClose CommentsPermalink

‘(i) obtain access to disparate sources of patient safety and outcomes data, including-- CommentsClose CommentsPermalink

‘(ii) link data obtained under clause (i) with information in the registry. CommentsClose CommentsPermalink

‘(A)(i) in the case of devices that are described in paragraph (1) and sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; and CommentsClose CommentsPermalink

‘(ii) in the case of devices that are described in paragraph (1) and sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health; CommentsClose CommentsPermalink

‘(B) shall establish procedures-- CommentsClose CommentsPermalink

‘(C) may require device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks; CommentsClose CommentsPermalink

‘(D) shall establish requirements for regular and timely reports to the Secretary, which shall be included in the registry, concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; and CommentsClose CommentsPermalink

‘(E) shall establish procedures to permit public access to the information in the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists. CommentsClose CommentsPermalink

(2) EFFECTIVE DATE- The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519(g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date. CommentsClose CommentsPermalink

(3) CONFORMING AMENDMENT- Section 303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by striking ‘519(g)’ and inserting ‘519(h)’. CommentsClose CommentsPermalink

(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.

[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