Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff

Description

FDA reviews pediatric devices through all of its premarket pathways, including premarket notification (510(k)), premarket approval (PMA), biological license application (BLA), and humanitarian device exemption (HDE). A manufacturer may show substantial equivalence to a predicate device, or may seek marketing approval by demonstrating with reasonable assurance that the device is safe and effective for its intended use. Clinical evaluation may be needed to support marketing of a device indicated for pediatric use. If such studies are needed, they should be conducted in accordance with the investigational device exemptions (IDE) regulation (21 CFR Part 812). FDA has jurisdiction over significant risk studies, whereas Institutional Review Boards (IRBs) have oversight responsibility for non-significant risk studies.

Scope & Applicability

Regulatory Context

• 21CFR50.54§ 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

  If an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter and involving children as subjects meets the requirements of § 50.51 , § 50.52 , or § 50.53 , the clinical investigation may proceed only if:Read full regulation →

• 21CFR50.53§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.

  Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is Read full regulation →

• 21CFR50.52§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

  Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely tRead full regulation →

• 21CFR50.51§ 50.51 Clinical investigations not involving greater than minimal risk.

  Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:Read full regulation →

• 21CFR50.3§ 50.3 Definitions.

  As used in this part:Read full regulation →

• 21CFR50.20§ 50.20 General requirements for informed consent.

  Except as provided in §§ 50.22 , 50.23 , and 50.24 , no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An invesRead full regulation →

• 21CFR56.111§ 56.111 Criteria for IRB approval of research.

  (a) In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:Read full regulation →

• 21CFR814.3§ 814.3 Definitions.

  For the purposes of this part:Read full regulation →

• 21CFR50.55§ 50.55 Requirements for permission by parents or guardians and for assent by children.

  (a) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent.Read full regulation →

• 21CFR807.87§ 807.87 Information required in a premarket notification submission.

  Each premarket notification submission shall contain the following information:Read full regulation →

• 21CFR814.20§ 814.20 Application.

  (a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →

• 21CFR814.104§ 814.104 Original applications.

  (a) United States applicant or representative. The applicant or an authorized representative shall sign the HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be countersigned by an authorized representative residing or maintaining a place of buRead full regulation →

• Clinical Investigator

  Shirish M. Gadgeel, M.D.

  2025-09-09

• Clinical Investigator

  Mark J. Savant, M.D

  2025-07-15

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Clinical Investigator

  Americo F. Padilla, M.D.

  2025-03-25

• Institutional Review Board (IRB)

  Armstrong County Memorial Hospital

  2024-11-05

• Clinical Investigator

  Namita A. Goyal, M.D.

  2024-10-22

• Institutional Review Board (IRB)

  Louisiana State University Health Science Center IRB

  2024-10-08

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Clinical Investigator (Sponsor)

  Angela D. Ritter, M.D.

  2024-06-18

• Institutional Review Board (IRB)

  New York State Psychiatric Institute IRB

  2024-03-26

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