Description
Thisguidanceclarifies the Food and Drug Administration’s (FDA or the Agency) current policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs). More specifically, this guidance outlines how FDA considers the role of postmarket information in determining the extent of data that should be collected in the premarket setting to support premarket approval while still meeting the statutory standard of reasonable assurance of safety and effectiveness.
Scope & Applicability
Product Classes
4Devices subject to premarket approval (PMA) and the balancing of data collection.
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
stents with higher rates of thrombosis compared to bare metal stents
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2Assessment for both mother and child
Update to Magnetic Resonance labeling
Related CFR Sections (4)
- 21CFR814.82§ 814.82 Postapproval requirements.
(a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read full regulation →
- 21CFR814.46§ 814.46 Withdrawal of approval of a PMA.
(a) FDA may issue an order withdrawing approval of a PMA if, from any information available to the agency, FDA determines that:Read full regulation →
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
Related Warning Letters (7)
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-03-12
Investigational Review Board (IRB)
Nobles Medical Technology II, Inc.
- 2023-11-14
CGMP/QSR/Medical Devices/Misbranded
Wello Inc.
- 2023-04-04
CGMP/QSR/Medical Devices/Adulterated
Synovo Production, Inc.
- 2020-05-14
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Allergan
- 2020-04-07
Investigational Device Exemptions (Clinical Investigator)
Kennedy, Philip R.
See Also (7)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators (Status: Final)
- FDA Inspections of Clinical Investigators: Guidance For IRBs, Clinical Investigators, and Sponsors (Status: Final)
- Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards (Status: Draft)
- Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls (Status: Final)
- Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety Audits (Status: Final)