Description
This guidance provides information on the Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) modular review program and the procedures for submitting or reviewing a modular PMA or HDE.
Scope & Applicability
Stakeholders
4Entity submitting development data and knowledge; Entity performing the work process for change
FDA contact for modular review steps
FDA contact for modular review steps
Assigned from an Office of Health Technology as the primary point of contact.
Regulatory Context
Attributes
4Information submitted in early modules of a modular review.
Data typically submitted in the final stages of a modular review.
Regulatory classification for devices requiring PMA
Review timeframe for individual modules; The timeframe for the review of the first module starting after payment and eCopy receipt.
Related CFR Sections (7)
- 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 →
- 21CFR814.37§ 814.37 PMA amendments and resubmitted PMAs.
(a) An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information.Read full regulation →
- 21CFR814.106§ 814.106 HDE amendments and resubmitted HDE's.
An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of FDA, for the same reasons and in the same manner as prescribed for PMA's in § 814.37 , except that the timeframes set forth in § 814.37(c)(1) and (d) do not apply. If FDA requests an HDE aRead full regulation →
- 21CFR814.40§ 814.40 Time frames for reviewing a PMA.
Within 180 days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, FDA will review the PMA and, after receiving the report and recommendation of the appropriate FDA advisory committee, send the applicant an approval order under §Read full regulation →
- 21CFR814.116§ 814.116 Procedures for review of an HDE.
(a) Substantive review. FDA will begin substantive review of an HDE after the HDE is accepted for filing under § 814.112 . FDA may refer an original HDE application to a panel on its own initiative, and shall do so upon the request of an applicant, unless FDA determines that the application substantRead full regulation →
- 21CFR814.112§ 814.112 Filing an HDE.
(a) The filing of an HDE means that FDA has made a threshold determination that the application is sufficiently complete to permit substantive review. Within 30 days from the date an HDE is received by FDA, the agency will notify the applicant whether the application has been filed. FDA may refuse tRead full regulation →
See Also (8)
- Suggested Format For IDE Progress Report (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff (Status: Final)