Diagnostic Kits/Glossary - Revision history

DavidO: /* PreMarket Notification 510(K) */

2010-06-29T14:57:14Z

PreMarket Notification 510(K)

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	''See [[Diagnostic_Kits/USA_Regulation_Review#Pre-Market_Approvals_.28PMAs.29\|FDA Pre-Market Approvals]]''		''See [[Diagnostic_Kits/USA_Regulation_Review#Pre-Market_Approvals_.28PMAs.29\|FDA Pre-Market Approvals]]''

	== ~~PreMarket Notification~~ 510(K) ==		==510(k) Pre-Market Notifications==
	The 510(k) process requires manufacturers of medical devices to notify the FDA, at least 90 days in advance, of their intent to market a product in the US. The Agency then determines if the product is exempt (subject only to the general controls of the statute), is as safe and as effective as a legally marketed device of the same generic type or that the device requires premarket approval. A new device found to be not substantially equivalent (“NSE”) is classified as class III and a substantially equivalent new device is classified in the same regulatory class, either class II or class I, as the device to which it is found equivalent. Therefore, the 510(k) process serves as a means to classify new devices. [1]		''See [[Diagnostic_Kits/USA_Regulation_Review#510.28k.29_Pre-Market_Notification_.28PMN.29\|FDA 510(k) Pre-Market Notifications]]''

	~~So all medical devices must pass through the 510(k) process on their path to the market, and the riskiest devices - those classified as Class III through the 510(k) - must also receive~~ [[Diagnostic_Kits/~~Glossary~~#~~PreMarket_Approval_~~.~~28PMA~~.29\|~~premarket approval]], which is a much more elaborate process involving clinical trials.~~

	* [1] AdvaMed (2008), ''The 510(k) ~~Process: The Key to Effective Device Regulation~~''~~. pp. 8-9~~

			==Navigation==
			Back to [[Diagnostic Kits]]<br/>
	[[Category:Diagnostic Kits]]		[[Category:Diagnostic Kits]]

DavidO: /* PreMarket Approval (PMA) */

2010-06-29T14:55:18Z

PreMarket Approval (PMA)

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	See the recent paper by [[Diagnostic_Kits/Clinically Available Pharmacogenomics Tests\|Flockhart et al]] for a review of 11 pharmacogenomic diagnostics currently on the market.		See the recent paper by [[Diagnostic_Kits/Clinically Available Pharmacogenomics Tests\|Flockhart et al]] for a review of 11 pharmacogenomic diagnostics currently on the market.

	== ~~PreMarket~~ Approval (PMA) ==		==Pre-market Approval (PMA)==
	~~"Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. ''~~'Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.''' Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance. Please note that some Class III preamendment devices may require a Class III 510(k). See ~~"Historical Background" for additional information.~~		''See [[Diagnostic_Kits/USA_Regulation_Review#Pre-Market_Approvals_.28PMAs.29\|FDA Pre-Market Approvals]]''

	~~PMA is the most stringent type of device marketing application required by FDA~~. ~~The applicant must receive FDA approval of its PMA application prior to marketing the device~~. ~~PMA approval is based on a determination by~~ FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. ''~~'The PMA owner, however, can authorize use of its data by another.'''" [1]~~

	~~[1] http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/default.htm~~


	== PreMarket Notification 510(K) ==		== PreMarket Notification 510(K) ==

DavidO: /* Clinical Laboratory Improvement Amendments (CLIA) */

2010-06-29T14:33:07Z

Clinical Laboratory Improvement Amendments (CLIA)

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	* [http://www.aacc.org/resourcecenters/resource_topics/tests/pages/default.aspx AACC.org Resources]		* [http://www.aacc.org/resourcecenters/resource_topics/tests/pages/default.aspx AACC.org Resources]

	== Clinical Laboratory Improvement Amendments (CLIA) ==		==Clinical Laboratory Improvement Amendments (CLIA)==
	''See [[Diagnostic_Kits/USA_Regulation_Review#CMS_Regulations\|CMS Regulations]]		''See [[Diagnostic_Kits/USA_Regulation_Review#CMS_Regulations\|CMS Regulations]]''

	==Analytical & Clinical Validity & Utility==		==Analytical & Clinical Validity & Utility==

DavidO: /* Clinical Laboratory Improvement Amendments (CLIA) */

2010-06-29T14:32:54Z

Clinical Laboratory Improvement Amendments (CLIA)

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	== Clinical Laboratory Improvement Amendments (CLIA) ==		== Clinical Laboratory Improvement Amendments (CLIA) ==
	The Clinical Laboratory Improvement Admendments Act or ("CLIA")<ref>Clinical Laboratory Improvement Amendments Act ("CLIA") Reuglations can be found at 42 U.S.C. § 263a et seq ; 42 C.F.R. § 493.1 et seq</ref> was passed by Congress in 1988. This act established: "quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health." This statute is enforced by the Centers for Medicare and Medicaid Services (“CMS”). CLIA regulates laboratories who conduct any type of testing—including genetic/genomic and non-genetic testing. The statute requires most laboratories who conduct testing for medical purposes to hold a CLIA certificate, issued by CMS.		''See [[Diagnostic_Kits/USA_Regulation_Review#CMS_Regulations\|CMS Regulations]]

	The requirements for CLIA-certification vary depending on the type of testing which is conducted by the labs. For highly complex testing, such as certain genetic tests, the laboratories may be required to have structured level of supervision over testing technicians and high levels of training over individuals who conduct the testing procedures.

	~~Certain areas of genetic diagnostics have been subject to more regulation under CLIA, by CMS, rather than the FDA (e.g., LDTs). For more information on this topic, please see our page on~~ [[Diagnostic_Kits/~~USA_Regulation~~\|~~U.S. Regulation of Diagnostic Kits]].~~

	~~'''''See Also:'''''~~
	* [http://www.cms.gov/clia/ CMS~~'s CLIA Overview~~]
	* [http://www.fda.gov/cdrh/CLIA/ FDA's page on CLIA]
	* [http://en.wikipedia.org/wiki/CLIA Wikipedia Entry on CLIA]

	==Analytical & Clinical Validity & Utility==		==Analytical & Clinical Validity & Utility==

DavidO: /* Genetics vs Genomics */

2010-06-29T14:30:31Z

Genetics vs Genomics

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	==Genetics vs Genomics==		==Genetics vs Genomics==
	Occasionally, the terms "Genetics" and "Genomics" are used interchangeably within the context of genetic testing. More specifically, both terms are sometimes used to refer to the testing of specific genes or the indexing of multiple tests of single genes. Unfortunately, the scientific community has distinct uses for these terms in contrast to marketing efforts by companies and in public discussion forums. The definitions below represent the scientific application of these terms.

	===Genetics===		===Genetics===
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	*[http://www.cdc.gov/genomics/gtesting/index.htm CDC.gov's page on Genetics]		*[http://www.cdc.gov/genomics/gtesting/index.htm CDC.gov's page on Genetics]
	*[http://www.genome.gov/19016904 Genome.gov FAQ's]		*[http://www.genome.gov/19016904 Genome.gov FAQ's]


	==Typology of Genetic Tests==		==Typology of Genetic Tests==

DavidO: /* In-Vitro Diagnostic Multivariate Index Assay (IVDMIAs) */

2010-06-29T14:17:32Z

In-Vitro Diagnostic Multivariate Index Assay (IVDMIAs)

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	==In-Vitro Diagnostic Multivariate Index Assay (IVDMIAs)==		==In-Vitro Diagnostic Multivariate Index Assay (IVDMIAs)==
			''See [[Diagnostic_Kits/USA_Regulation_Review#Regulatory_Classifications_of_Genetic_Tests\|Regulatory Classifications of Genetic Tests]]''
	IVDMIAs are a subset of IVD and LDT genetic tests. As the name implies, an IVDMIA is a test that assays multiple variables, like gender, age, weight, in combination with the results of certain genetic tests. These variables are then anayzled through a computer algorithm which generates a consumer-friendly report, detailing things such as health risk assessments and percentage calculations that indicate a disposition towards developing a disease, or more generally, a health risk assessment.

	In recent years, as manufacturers and laboratories have watched the application potential of IVDMIAs continue to increase, IVDMIAs have come under scrutiny for regulatory issues. Many testing providers would prefer IVDMIAs be classified as a LDT rather than a IVD or other type of medical device under the FDA's regulations. If classified as an LDT, IVDMIAs would be subject to less regulatory scrutiny and would not have to be approved by the FDA prior to sale on the market.

	Another problem perceived by some commentators is that the results generated by IVDMIAs do not allow for independent appraisal by an outside official or medical professional. For instance, rather than reporting the raw data which allowed the computer algorithm to generate a given set of results, many IVDMIA reports only provide an index or score report that consists of percetage calculations indicating probability of disease development or diagnosis.

	In 2007, the FDA has released draft guidelines that stated IVDMIAs will be considered Class II or Class III medical devices under the FFDCA depending on their intended use. Since then, over 192 different stakeholders have submitted comments To date, however, no final ruling has been issued from the FDA on the classification of IVDMIAs.

	~~'''~~''See ~~Also:'''~~''
	* http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079148.htm
	* http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2006-D-0233

	== Direct Access Testing (DAT) ==		== Direct Access Testing (DAT) ==

DavidO: /* Typology of Genetic Tests */

2010-06-29T13:36:05Z

Typology of Genetic Tests

@@ Line 105: / Line 105: @@
 ==Typology of Genetic Tests==
+''See [[Diagnostic_Kits/USA_Regulation_Review#Regulatory_Classifications_of_Genetic_Tests|Regulatory Classifications of Genetic Tests]]''
 ==In-Vitro Diagnostic Multivariate Index Assay (IVDMIAs)==

DavidO: /* Abbreviations */

2010-06-24T18:53:16Z

Abbreviations

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	\|-		\|-
	\|'''510(k)/PMA'''		\|'''510(k)/PMA'''
	\|Pre-Market Notification		\|[[Pre-Market Notification]]
	\|-		\|-
	\|'''ASR'''		\|'''ASR'''
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	\|CLIA		\|CLIA
	\|[[Clinical Laboratory Improvement Amendments Act]]		\|[[Clinical Laboratory Improvement Amendments Act]]
			\|-
			\|CMS
			\|[[Centers for Medicaid and Medicare Services]]
			\|-
			\|FDA
			\|[[Food and Drug Administration]]
	\|-		\|-
	\|IVDs		\|IVDs

DavidO: /* Abbreviations */

2010-06-24T18:42:16Z

Abbreviations

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	!Abbreviation !! Definition		!Abbreviation !! Definition
	\|-		\|-
	\|		\|'''510(k)/PMA'''
	\|		\|Pre-Market Notification
	\|-		\|-
	\|		\|'''ASR'''
	\|		\|[[Analyte Specific Reagent]]
	\|-		\|-
	\|		\|CLIA
	\|		\|[[Clinical Laboratory Improvement Amendments Act]]
	\|-		\|-
	\|		\|IVDs
	\|		\|[[''In Vitro'' Diagnostics]]
	\|-		\|-
			\|IVDMIAs
			\|[[''In Vitro'' Diagnostic Multi-Variate Assays]]
			\|-
			\|LDTs
			\|[[Laboratory Developed Tests]]
	\|}		\|}

DavidO: /* Abbreviations */

2010-06-24T16:30:57Z

Abbreviations

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	The table below is a list of commonly used abbreviations throughout this wiki.		The table below is a list of commonly used abbreviations throughout this wiki.

	{\| class="wikitable" border=1		{\| class="wikitable" border=1 align="center"
	\|+ '''Abbreviations'''		\|+ '''Abbreviations'''
	!Abbreviation !! Definition		!Abbreviation !! Definition