CURRENT FTC GUIDELINES:

A product may be advertised as “Made in the USA” if “all or virtually all” of the labor and materials in the product are domestic. While this standard is relatively strict, it allows a bit of flexibility in at least two situations.

First, if the product is fully manufactured in the U.S. – primarily from U.S. materials, but with a very small amount of foreign content – the FTC standard allows the product to be described as “Made in the USA.”

Second, the advertiser has the option to soften or “qualify” its Made in the USA claim by disclosing, for example, that the product is made in the U.S. with foreign and domestic materials.

BERRY AMENDMENT COMPLIANCE DEFINITION:

The Berry Amendment Compliance is a federal regulation that requires Department of Defense funds to be spent on U.S. manufactured items in order to protect the United States industrial market during times of war.

The Berry Amendment is intended for companies that wish to acquire Department of Defense contracts. This amendment applies to products such as food, clothing, tents, materials, and tools. Some exceptions include if the product is unavailable from a U.S. source, purchasing from allies, perishable food or emergency items for personnel located outside of the United States, and purchases at or below the simplified acquisition threshold. These determinations can only be made by specific officials who must provide supporting documentation.

Companies wishing to obtain compliance must guarantee that their products (including all components) are 100 percent domestic.

FDA REQUIREMENTS:

FDA CFR - CODE OF FEDERAL REGULATIONS TITLE 21

The information on this page is current as of October 17, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations][Title 21, Volume 8][CITE: 21CFR878.5910]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart F - Therapeutic Devices

Sec. 878.5910 Pneumatic tourniquet.

(a) Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001]

Page Last Updated: 10/17/2023

MEDICAL DEVICE EXEMPTIONS: 510(K) AND GMP REQUIREMENTS:

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general record keeping requirements and compliant files.

Class I Devices:

FDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "\#\" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm

IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

CAGE CODE, NSN, NIIN, United States Department of Defense, DOD

Forefront Innovators, LLC

CAGE Code: 9RGF7

NCAGE Code: 9RGF7

Status: Active

Type: Commercial Supplier

EU REQUIREMENTS FOR CE MARKING:

Approved for medical use by the European Union

EC REP: EUROPCERT (UG)

(HALFUNGSBESCHRANKT)

ALSSTR. 97, 41063

MONCHENGLADBACH, GERMANY

+49 (0) 2161 990 883 1

Forefront Innovators, LLC

SRN EUDAMED regulations US-MF-000041222

Status: Active

Type: Medical Device

UDI REQUIREMENTS:

Class 1: Placing UDI- carries on the labels of devices. Required 26 May 2025