Questions about the Drug and Device Resource Service?

 

  1. What is a drug?
  2. What is a biologic product?
  3. What is a device?
  4. What is an Investigational New Drug (IND) application and why is it needed?
  5. What is an Investigational Device Exemption (IDE) application and why is it required?
  6. What is the definition of sponsor under FDA regulations?
  7. What is the definition of investigator under FDA regulations?
  8. What is the definition of sponsor-investigator under FDA regulations?
  9. What is a Significant Risk (SR) device?
  10. What is a Nonsignificant Risk (NSR) device?
  11. What is Good Clinical Practice (GCP)?

 

  1. What is a drug?

The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

 Note: Access to United States Pharmacopoeia/National Formulary is available through Welch Medical Library electronic resources.

Reference: FD&C Act, sec. 201(g)(1)

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  1. What is a biologic product?

Biological product means any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man:

(1) A virus is interpreted to be a product containing the minute living cause of an infectious disease and includes but is not limited to filterable viruses, bacteria, rickettsia, fungi, and protozoa.

(2) A therapeutic serum is a product obtained from blood by removing the clot or clot components and the blood cells.

(3) A toxin is a product containing a soluble substance poisonous to laboratory animals or to man in doses of 1 milliliter or less (or equivalent in weight) of the product, and having the property, following the injection of non-fatal doses into an animal, of causing to be produced therein another soluble substance which specifically neutralizes the poisonous substance and which is demonstrable in the serum of the animal thus immunized.

(4) An antitoxin is a product containing the soluble substance in serum or other body fluid of an immunized animal which specifically neutralizes the toxin against which the animal is immune.

(5) A product is analogous:
(i) To a virus if prepared from or with a virus or agent actually or potentially infectious, without regard to the degree of virulence or toxicogenicity of the specific strain used.

(ii) To a therapeutic serum, if composed of whole blood or plasma or containing some organic constituent or product other than a hormone or an amino acid, derived from whole blood, plasma, or serum.

(iii) To a toxin or antitoxin, if intended, irrespective of its source of origin, to be applicable to the prevention, treatment, or cure of disease or injuries of man through a specific immune process.

Reference: 21CFR600.3(h)

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  1. What is a device?

The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Reference: FD&C Act, sec. 201(h)

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  1. What is an Investigational New Drug (IND) application and why is it needed?

Before a new drug or biologic product can be administered to humans, a Sponsor or Sponsor-Investigator, must receive authorization from the Food and Drug Administration (FDA) to allow the administration of the product. In addition, before the product can be shipped across state lines, the Sponsor or Sponsor-Investigator must also receive FDA authorization for such shipments. The Investigational New Drug Application (IND) is the mechanism used to request authorization from the FDA for the administration and interstate shipments of the product. After the Sponsor or Sponsor-Investigator submits the IND application and receives authorization from the FDA, then the product may be administered to humans and/or transported across state lines.

An IND application may also be required for a drug that is subject of a FDA approved new drug application (21CFR314) or Biologic License Application (21CFR601) if the product under clinical investigation does not meet exemption requirements set forth in 21CRF312.2(b). The exemption requirements included:

(i) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;

(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;

(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 [21CFR56] and with the requirements for informed consent set forth in part 50 [21CFR50]; and

(v) The investigation is conducted in compliance with the requirements of 312.7 [Promotion of investigational drugs, 21CFR312.7].

References:

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  1. What is an Investigational Device Exemption (IDE) application and why is it required?

An investigational device exemption (IDE) [21CFR812] allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application [21CFR814] or a Premarket Notification, 510(k), [21CFR807 Subpart E] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)’s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

Clinical evaluation of devices that have not been cleared for marketing requires:

  • an IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
  • informed consent from all patients;
  • labeling for investigational use only;
  • monitoring of the study and;
  • required records and reports.

An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDE’s are also exempt from the Quality System (QS) Regulation [21CFR820] except for the requirements for design control [21CFR820 part C].

Reference: FDA CDRH website – Device Advice: Investigational Device Exemption (IDE)

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  1. What is the definition of sponsor under FDA regulations?

Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article [i.e., drug, biologic, device, or combination of the three] is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.

Reference: 21CFR50.3(e)

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  1. What is the definition of investigator under FDA regulations?

Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

Reference: 21CFR50.3(d)

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  1. What is the definition of sponsor-investigator under FDA regulations?

Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., corporation or agency.

Reference: 21CFR50.3(f)

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  1. What is a Significant Risk (SR) device?

Significant risk device means an investigational device that:
(1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

(2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;

(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or

(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Reference: 21CFR812.3(m)

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  1. What is a Nonsignificant Risk (NSR) device?

Nonsignificant risk device is a device that does not pose a ‘significant risk’ to humans, (i.e., does not meet the definition of a SR device (21CFR812(m)))

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  1. What is Good Clinical Practice (GCP)?

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

Reference: ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1), 1996.

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