I looked at page 1000 to see what this was all about and it DOES talk about implanted devices- read it here: (actual text)
9 Subtitle C—National Medical
10 Device Registry
11 SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.
12 (a) REGISTRY.—
13 (1) IN GENERAL.—Section 519 of the Federal
14 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is
15 amended—
16 (A) by redesignating subsection (g) as sub17
section (h); and
18 (B) by inserting after subsection (f) the
19 following:
20 ‘‘National Medical Device Registry
21 ‘‘(g)(1) The Secretary shall establish a national med22
ical device registry (in this subsection referred to as the
23 ‘registry’) to facilitate analysis of postmarket safety and
24 outcomes data on each device that—
25 ‘‘(A) is or has been used in or on a patient; and
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1 ‘‘(B) is—
2 ‘‘(i) a class III device; or
3 ‘‘(ii) a class II device that is implantable,
4 life-supporting, or life-sustaining.
5 ‘‘(2) In developing the registry, the Secretary shall,
6 in consultation with the Commissioner of Food and Drugs,
7 the Administrator of the Centers for Medicare & Medicaid
8 Services, the head of the Office of the National Coordi9
nator for Health Information Technology, and the Sec10
retary of Veterans Affairs, determine the best methods
11 for—
12 ‘‘(A) including in the registry, in a manner con13
sistent with subsection (f), appropriate information
14 to identify each device described in paragraph (1) by
15 type, model, and serial number or other unique iden16
tifier;
17 ‘‘(B) validating methods for analyzing patient
18 safety and outcomes data from multiple sources and
19 for linking such data with the information included
20 in the registry as described in subparagraph (A), in21
cluding, to the extent feasible, use of—
22 ‘‘(i) data provided to the Secretary under
23 other provisions of this chapter; and
24 ‘‘(ii) information from public and private
25 sources identified under paragraph (3);
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1 ‘‘(C) integrating the activities described in this
2 subsection with—
3 ‘‘(i) activities under paragraph (3) of sec4
tion 505(k) (relating to active postmarket risk
5 identification);
6 ‘‘(ii) activities under paragraph (4) of sec7
tion 505(k) (relating to advanced analysis of
8 drug safety data); and
9 ‘‘(iii) other postmarket device surveillance
10 activities of the Secretary authorized by this
11 chapter; and
12 ‘‘(D) providing public access to the data and
13 analysis collected or developed through the registry
14 in a manner and form that protects patient privacy
15 and proprietary information and is comprehensive,
16 useful, and not misleading to patients, physicians,
17 and scientists.
18 ‘‘(3)(A) To facilitate analyses of postmarket safety
19 and patient outcomes for devices described in paragraph
20 (1), the Secretary shall, in collaboration with public, aca21
demic, and private entities, develop methods to—
22 ‘‘(i) obtain access to disparate sources of
23 patient safety and outcomes data, including—
24 ‘‘(I) Federal health-related electronic
25 data (such as data from the Medicare pro-
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1 gram under title XVIII of the Social Secu2
rity Act or from the health systems of the
3 Department of Veterans Affairs);
4 ‘‘(II) private sector health-related
5 electronic data (such as pharmaceutical
6 purchase data and health insurance claims
7 data); and
8 ‘‘(III) other data as the Secretary
9 deems necessary to permit postmarket as10
sessment of device safety and effectiveness;
11 and
12 ‘‘(ii) link data obtained under clause (i)
13 with information in the registry.
14 ‘‘(B) In this paragraph, the term ‘data’ refers to in15
formation respecting a device described in paragraph (1),
16 including claims data, patient survey data, standardized
17 analytic files that allow for the pooling and analysis of
18 data from disparate data environments, electronic health
19 records, and any other data deemed appropriate by the
20 Secretary.
21 ‘‘(4) Not later than 36 months after the date of the
22 enactment of this subsection, the Secretary shall promul23
gate regulations for establishment and operation of the
24 registry under paragraph (1). Such regulations—
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1 ‘‘(A)(i) in the case of devices that are described
2 in paragraph (1) and sold on or after the date of the
3 enactment of this subsection, shall require manufac4
turers of such devices to submit information to the
5 registry, including, for each such device, the type,
6 model, and serial number or, if required under sub7
section (f), other unique device identifier; and
8 ‘‘(ii) in the case of devices that are described in
9 paragraph (1) and sold before such date, may re10
quire manufacturers of such devices to submit such
11 information to the registry, if deemed necessary by
12 the Secretary to protect the public health;
13 ‘‘(B) shall establish procedures—
14 ‘‘(i) to permit linkage of information sub15
mitted pursuant to subparagraph (A) with pa16
tient safety and outcomes data obtained under
17 paragraph (3); and
18 ‘‘(ii) to permit analyses of linked data;
19 ‘‘(C) may require device manufacturers to sub20
mit such other information as is necessary to facili21
tate postmarket assessments of device safety and ef22
fectiveness and notification of device risks;
23 ‘‘(D) shall establish requirements for regular
24 and timely reports to the Secretary, which shall be
25 included in the registry, concerning adverse event
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1 trends, adverse event patterns, incidence and preva2
lence of adverse events, and other information the
3 Secretary determines appropriate, which may include
4 data on comparative safety and outcomes trends;
5 and
6 ‘‘(E) shall establish procedures to permit public
7 access to the information in the registry in a manner
8 and form that protects patient privacy and propri9
etary information and is comprehensive, useful, and
10 not misleading to patients, physicians, and sci11
entists.
12 ‘‘(5) To carry out this subsection, there are author13
ized to be appropriated such sums as may be necessary
14 for fiscal years 2010 and 2011.’’.
15 (2) EFFECTIVE DATE.—The Secretary of
16 Health and Human Services shall establish and
17 begin implementation of the registry under section
18 519(g) of the Federal Food, Drug, and Cosmetic
19 Act, as added by paragraph (1), by not later than
20 the date that is 36 months after the date of the en21
actment of this Act, without regard to whether or
22 not final regulations to establish and operate the
23 registry have been promulgated by such date.
24 (3) CONFORMING AMENDMENT.—Section
25 303(f)(1)(B)(ii) of the Federal Food, Drug, and
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1 Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amend2
ed by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’.
3 (b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED
4 ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE
5 IDENTIFIERS.—
6 (1) RECOMMENDATIONS.—The HIT Policy
7 Committee established under section 3002 of the
8 Public Health Service Act (42 U.S.C. 300jj–12)
9 shall recommend to the head of the Office of the Na10
tional Coordinator for Health Information Tech11
nology standards, implementation specifications, and
12 certification criteria for the electronic exchange and
13 use in certified electronic health records of a unique
14 device identifier for each device described in section
15 519(g)(1) of the Federal Food, Drug, and Cosmetic
16 Act, as added by subsection (a).
17 (2) STANDARDS, IMPLEMENTATION CRITERIA,
18 AND CERTIFICATION CRITERIA.—The Secretary of
19 the Health Human Services, acting through the
20 head of the Office of the National Coordinator for
21 Health Information Technology, shall adopt stand22
ards, implementation specifications, and certification
23 criteria for the electronic exchange and use in cer24
tified electronic health records of a unique device
25 identifier for each device described in paragraph (1),
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1 if such an identifier is required by section 519(f) of
2 the Federal Food, Drug, and Cosmetic Act (21
3 U.S.C. 360i(f)) for the device
See? Isn’t that simple?
My doctor will jump on this right now...