9. Compliance Activities
FDA evaluates manufacturer compliance with the medical device regulations primarily by factory inspections. During the inspection, the FDA investigator will review your facilities, design controls (for surgeon’s gloves), manufacturing operations, environment, and records to determine your level of compliance. The emphasis will be on compliance with the Quality System regulation (21 CFR part 820). The FDA inspection program includes foreign manufacturing sites. FDA will contact foreign firms to schedule an inspection.
You will find guidance on how FDA conducts factory inspections, including regulatory sanctions FDA can take against noncompliant firms, in the following guidance documents.
Factory Inspections (Medical Device Quality Systems Manual: A Small Entity Compliance Guide)
Quality System Inspection Technique (QSIT)
You will find information on the FDA import process at "Importing into the U.S.". FDA may collect a sample of your gloves and test the gloves in accordance with 21 CFR 800.20, “Patient examination gloves and surgeon’s gloves; sample plans and test method for leakage defects; adulteration.” Sketches of the test apparatus described in 21 CFR 800.20 are provided in Appendix A.
When a glove shipment includes multiple lots or sizes, it is considered a commingled shipment. FDA usually will not sample each individual lot within a commingled shipment. In the sample, FDA will include only one type of glove (surgeon’s gloves or examination gloves) and will attempt to represent glove sizes in the sample as they occur in the overall shipment. Also, FDA will attempt to include several lot numbers, if present. However, exact proportional representation of all lots or sizes is not necessary to obtain a representative sample for testing. A shipment of gloves may be refused entry based on the appearance of adulteration (Section 801 of the Act; 21 U.S.C. 381), and such an appearance can be obtained even if the sample includes only one lot number or one size. If the sample fails, FDA will detain all lotsof the same glove type (surgeon’s gloves or examination gloves) in the shipment.
FDA provides its sampling methodology and defect action levels in the FDA Compliance Policy Guide, Chapter 3, Section 335.700, Surgeon’s Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure.
CPG 335.700 Surgeon’s Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure (CPG 7124.31)
FDA may pursue regulatory sanctions when medical devices are determined to be "adulterated" or "misbranded," or when individuals or firms commit certain "prohibited acts." (Sections 301, 501, and 502 of the Act; 21 U.S.C. 331, 351, and 352.) These generic terms also apply to other products that FDA regulates, such as foods, drugs, and cosmetics; however, the causes of adulteration and misbranding are not identical for all products. The following summarizes some common reasons why FDA may consider medical gloves to be adulterated or misbranded.
Generally, a charge of adulteration indicates a potentially serious problem with the medical device itself. Section 501 of the Act describes possible reasons for adulteration. Several common examples of adulterated medical gloves are:
- Gloves that do not provide an intact barrier as evidenced by failure of a water leak test (21 CFR 800.20). The gloves are adulterated according to section 501(c) - failure of the gloves to have the quality that they are represented to have.
- Gloves that have never been cleared to market are automatically classified in Class III (section 513(f)(1) of the Act). Without clearance or approval, the gloves are adulterated according to section 501(f)(1)(B)(i).
- Gloves that have been manufactured, packaged, or stored in a facility that was inspected by FDA and that was found not in conformity with the Quality System regulation (21 CFR part 820). The gloves are adulterated according to section 501(h) because the facilities and controls used for manufacturing, packing, and storage do not meet GMPs as described in the Quality System regulation (21 CFR 820).
Usually, a charge of misbranding indicates a problem with the labeling or documentation of the device or device manufacturer. Section 502 of the Act describes possible reasons for misbranding. Several common examples of misbranded medical gloves are:
- Gloves that have exaggerated, untrue, or unsubstantiated claims are “misbranded” under section 502(a) of the Act, because the labeling is false or misleading in some manner. Examples of claims that may misbrand a medical glove include:
- “Leak Proof” or similar unsupportable claims of performance
- “Hypoallergenic” claims for latex gloves (prohibited by 21 CFR 801.437(h))
- “Antimicrobial” claims without supporting data
- “Accelerator Free”
- “Skin Care” claims without supporting data
- “Synthetic Gloves” that do not identify the material
- “Low Protein” claims that do not quantify the amount of protein
- “Extra Thick” claims that do not quantify the thickness
- “Lightly Powdered” claims
- Natural rubber latex gloves that do not include the latex "Caution" statement required by 21 CFR 801.437. These gloves are misbranded under section 502(a) because the labeling fails to reveal important information about the use of the product as required by section 201(n).
- Gloves that are not labeled with the name of the manufacturer or distributor are misbranded according to section 502(b).
- Disposable gloves that are not labeled with a statement "For single use only" are misbranded according to section 502(f)(1) for failure to have adequate directions for use.
- Gloves that do not meet applicable registration and listing requirements are misbranded according to section 502(o).
Disposition of Adulterated or Misbranded gloves
If any lots of medical gloves are found to be adulterated or misbranded, the manufacturer or importer of record may request to recondition the gloves to bring them into compliance (see 21 CFR 800.20(d)).
The importer of record should advise the FDA District Office that initiated the detention of the firm's plans to bring the product into compliance. If the gloves cannot be brought into compliance, they cannot be marketed in the U.S. as medical gloves.
Non-conforming medical gloves may be brought into conformance by:
- reconditioning to correct the non-conformance, i.e., remove defective gloves, correct labeling deficiencies; or
- reconditioning by relabeling, and subsequently distributing the gloves for non-medical use, or non-FDA regulated use.
A manufacturer/importer that chooses to recondition the product should request and obtain permission from the responsible FDA District Office.
The importer of record may also request permission to recondition a commingled shipment that has failed FDA analysis by testing each lot or size in the shipment to identify whether some lots or sizes meet the specified acceptable quality levels. Because the original analysis provides an appearance of adulteration, FDA will need greater assurance that the reconditioned gloves are not adulterated. The importer should consult with the FDA District Office to obtain the appropriate sampling plan. Only those lots/sizes that are shown to be in compliance, subject to verification testing by FDA, can be released for distribution in the U.S.
If nonconforming medical gloves cannot be reconditioned, the medical gloves should be
- re-exported to the country of manufacture or to a country where the gloves would meet local laws, or
- destroyed, usually via landfill.
Detention is the action that FDA takes against imported medical devices that do not comply with the laws that FDA administers (21 CFR 800.55)). FDA may detain imported medical devices whenever physical examination or testing of a medical device, or examination of medical device labeling and labeling claims by FDA show that the medical device violates FDA laws. The importer of record may file an appeal requesting an informal hearing. A presiding FDA officer will affirm or revoke the detention. Detained devices are either released if brought into compliance or refused entry if not brought into compliance.
Detention Without Physical Examination
Detention Without Physical Examination (DWPE) is the act by FDA of detaining the entry of a specified article, usually from a specific supplier, and occasionally from all suppliers from a specific country, without physical examination or testing.DWPE differs from general administrative detention in that it is imposed based on the previous violative history of an imported medical device being offered for entry into the U.S. DWPE does not occur as a result of a violative analysis or evaluation of the present entry found by FDA. DWPE is an action used for repeat violations or violators. DWPE essentially places the responsibility for determining quality and compliance with the law upon the U.S. importer or broker, and indirectly upon the foreign supplier (or sometimes a country). DWPE is generally based on information regarding the past violative history of the medical device and/or other information indicating that the medical device may be violative.
DWPE actions are implemented through the issuance of FDA “Import Alerts.” A list of medical glove related FDA Import Alerts is provided below:
There are currently several import alerts under which medical gloves are commonly refused entry. Import alerts provide the reason for the alert and provide information on how to be removed from the alert:
- Import Alert #80-04, “Surveillance and Detention without Physical Examination of Surgeon’s and/or Patient Examination Gloves.”
Manufacturers/shippers placed on this alert have had at least one previous failure of their gloves to pass an FDA analysis. This import alert consists of three increasingly more stringent levels of detention for manufacturers/shippers who repeatedly attempt to import adulterated gloves (Recidivist Firms).
- Import Alert #89-04, “Detention without Physical Examination of Devices that have not met Device GMPs.”
Manufacturers/shippers placed on this alert have had a violative FDA inspection and are not manufacturing in accordance with Quality System regulation. Manufacturers may be removed from the alert after an FDA inspection has verified corrective action.
- Import Alert #89-08, “Detention without Physical Examination of Class III Medical Devices Without Approved PMAs/IDEs or Other Devices Not Found Substantially Equivalent.”
Manufacturers/shippers placed on this alert do not have a cleared 510(k) for their gloves. Manufacturers may have their gloves removed from the alert after they receive a 510(k) marketing clearance letter for the specific glove type (powdered, powder-free, vinyl, etc.).
Importers may contact FDA near the port of entry and speak to the import operations staff regarding their entry. Callers should have their entry numbers available for reference.
More information regarding DWPE of gloves, including information regarding removal from DWPE, may be found in the FDA guidance, “Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves.”
Appendix A provides sketches of the test apparatus described in 21 CFR 800.20, Patient examination gloves and surgeon’s gloves; sample plans and test method for leakage defects; adulteration. FDA's analysis of gloves for leaks is conducted by a water leak method using 1,000 milliliters (mL) of water. Each medical glove is analyzed independently. A leak is defined as the appearance of water on the outside of the glove. Emergence of water from the glove constitutes a watertight barrier failure. Leaks within 1 and ½ inches of the cuff are disregarded.