Outline of FDA Device Regulations .

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2. Diagram of FDA Device Regulations - Outline. IntroductionEstablishment Registration
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Diagram of FDA Device Regulations Bob Assenzo Critical Path Institute bassenzo@c-path.org

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Overview of FDA Device Regulations - Outline Introduction Establishment Registration – 21 CFR 807 Medical Device Listing – 21 CFR 805 Premarket Notification 510(k) – 21 CFR 807 Subpart E Premarket Approval (PMA) – 21 CFR 814

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Overview of FDA Device Regulations – Outline (cont.) Investigational Device Exemption (IDE) – 21 CFR 812 Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR 820 Labeling – 21 CFR 801 Medical Device Reporting – 21 CFR 803

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Introduction to Device Regulations FDA\'s Center for Devices & Radiological Health (CDRH) is in charge of controlling firms that fabricate, repackage, relabel, as well as import therapeutic gadgets sold in the US. Also, CDRH manages radiation-discharging electronic items (medicinal & non-therapeutic, for example, lasers, x-beam frameworks, ultrasound gear, microwave stoves & shading TVs

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Introduction to Device Regulations Classifications Medical gadgets are characterized into Class I, II, and III. Administrative control increments from Class I to III. The gadget grouping characterizes the administrative necessities for a general gadget sort.

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Introduction to Device Regulations Classifications (cont.) Most Class I gadgets are excluded from Premarket Notification 510(k) Most Class II gadgets require Premarket Notification 510(k) Most Class III gadgets require Premarket Approval For order assurance see: www.fda.gov/cdrh/devadvice/313.html

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Device Classification Panels Most restorative gadgets can be found in 21 CFR 862 – 893 FDA has characterized and portrayed more than 1,700 unmistakable sorts and composed them into 16 therapeutic claim to fame boards, e.g. 870 is cardiovascular; 886 is ophthalmic The CFR gives a general portrayal, utilize, class, and information about promoting prerequisites www.fda.gov/cdrh/devadvice/3131.html

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Introduction to Device Regulations Basic Requirements Establishment enlistment Medical Device Listing Premarket Notification 510(k), unless absolved, or Premarket Approval (PMA) Investigational Device Exemption (IDE) for clinical reviews Quality System (QS) control Labeling necessities Medical Device Reporting (MDR)

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Establishment Registration – 21 CFR Part 807 Manufacturers, household & outside, and starting merchants (shippers) of therapeutic gadgets must enroll their foundations with the FDA. All foundation enlistments must be submitted electronically, unless FDA concedes a waiver All enrollment data must be confirmed every year (Oct 1-Dec 31) Foreign producers likewise should assign a US operator Most foundations are required to pay a foundation enlistment expense

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Medical Device Listing – 21 CFR Part 807 Manufacturers must rundown their gadgets with the FDA. Foundations required to rundown: Manufacturers Contract producers that industrially disseminate the gadget Repackagers and relabelers Specification designers Reprocessors single-utilize gadgets Remanufacturer Manufacturers of embellishments and segments sold straightforwardly to the end client US makers of "fare just" gadgets

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Premarket Notification 510(k) – 21 CFR Part 807 Subpart E If gadget requires the accommodation of a Premarket Notification 510(k), it can\'t be financially dispersed until an approving letter of significant equality from FDA is gotten A 510(k) must show that the gadget is considerably identical to one legitimately in business appropriation in the US: (1) preceding May 28, 1976, or (2) to a gadget that has been dictated by FDA to be generously comparable www.fda.gov/cdrh/devadvice/314.html

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Premarket Notification 510(k) – 21 CFR Part 807 Subpart E (cont) The Medical Device User Fee and Modernization Act of 2002 approves FDA to charge an expense for medicinal gadget Premarket Notification 510(k) audits. Most Class I and some Class II gadgets are excluded from the Premarket Notification 510(k) accommodation. See www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

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Premarket Notification 510(k) – 21 CFR Part 807 Subpart E (cont) Review by Accredited Persons: FDA has licensed 12 associations to direct an essential audit of 670 sorts of gadgets. FDA must issue a last assurance inside 30 days in the wake of getting a suggestion from an Accredited Person Accredited Person is absolved from any FDA expense; the outsider may charge a charge for its survey

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Premarket Approval (PMA) – 21 CFR Part 814 Products requiring PMAs are Class III gadgets that are high hazard gadgets that represent a noteworthy danger of sickness or harm, or gadgets found not considerably identical to Class I & II predicate through the 510(k) handle (Fee required) The PMA procedure is more included and incorporates the accommodation of clinical information to bolster claims made for the gadget See www.fda.gov/cdrh/devadvice/pma/

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Investigational Device Exemption (IDE) – 21 CFR Part 812 An IDE permits the investigational gadget to be utilized as a part of a clinical review to gather wellbeing & viability information required to bolster a PMA application or a Premarket Notification 510(k) accommodation to FDA. Clinical investigations of gadgets with huge hazard must be endorsed by FDA and an IRB before study can start Studies of gadgets of nonsignificant hazard must be affirmed by the IRB before study can start See www.fda.gov/cdrh/devadvice/ide/index.shtml

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Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR Part 820 The quality framework direction incorporates necessities identified with the techniques utilized as a part of and the offices and controls utilized for: planning, acquiring, fabricating, bundling, marking, putting away, introducing and adjusting of restorative gadgets Manufacturing offices experience FDA examinations to guarantee consistence with the QS prerequisites See www.fda.gov/cdrh/devadvice/32.html

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Labeling – 21 CFR Part 801 Labeling incorporates names on the gadget and additionally enlightening and instructive writing that goes with the gadget www.fda.gov/cdrh/devadvice/33.html

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Medical Device Reporting – 21 CFR Part 803 Incidents in which a gadget may have brought on or added to a demise or genuine damage must be accounted for to the FDA Certain glitches likewise should be accounted for The MDR control is a component for recognizing and observing noteworthy Aes www.fda.gov/cdrh/devadvice/351.html

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Guidance Documents Good Guidance Practice (GGP) identify with: The preparing, substance, and assessment of administrative entries The outline, generation, assembling, and testing of managed items The review and requirement methodology www.fda.gov/cdrh/direction about.html

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