Description
This document supersedes "Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery," published on December 16, 1999.
Scope & Applicability
Product Classes
4Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Subject of the guidance document; Guidance for devices used in abdominal and/or pelvic surgery
The device type being discussed in the guidance
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.
Devices requiring full IDE submission
Stakeholders
6Governs top dose in clinical studies
FDA group providing input on post-approval studies
patients who enter and complete the study
cohort of all enrolled and treated patients
responsible for justifying omission of studies
Knowledge by investigators can impact trial integrity
Regulatory Context
Attributes
8Classification of metallic and calcium phosphate coated orthopedic devices
Primary outcomes to be measured in the study
clean, clean-contaminated, contaminated, or dirty
Quality parameter that must remain unchanged for the policy
Dating requirements for drug products compounded by outsourcing facilities.
Manufacturing section includes Product Expiration Dating
Characterization requirement for polymeric materials
Absorption, distribution, metabolism, and excretion characteristics; Absorption, distribution, metabolism, and excretion characteristics.
Identified Hazards
Hazards
2Disease agents associated with sepsis which may be caused by Mtb
exclusions such as fecal contamination
Related CFR Sections (5)
- 21CFR812.5§ 812.5 Labeling of investigational devices.
(a) Contents. An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 801.1 ), the quantity of contents, if appropriate, and the following statement: “CAUTIORead 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 →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR812.2§ 812.2 Applicability.
(a) General. This part applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in paragraph (c) of this section.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 →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (Status: Draft)
- Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval: Draft Guidance for Industry (Status: Draft)
- Non-Invasive Blood Pressure (NIBP) Monitor Guidance (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CHAPTER 48 - 7348.809 Bioresearch Monitoring (Status: Final)
- Investigational Medical Laser Significant Risk Device (Laser Notice 31) (Status: Final)
- Color Additive Petitions - Medical Devices (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)