The regulations allow for variances and exemptions from all or part of the standard, and from the reporting and recordkeeping requirements. A variance 1 37 is permission to vary from one or more requirements of the standard. Upon application by a manufacturer, the Director of CDRH may grant a variance for a product if it is determined that the variance is so limited in applicability that an amendment to the standard is not justified, or is of such need that there is not sufficient time for amending the standard, and that granting the variance is in agreement with the Radiation Control Act. Specifically, a variance may be granted if:
• there are alternate but at least equal means of safety; or
• there are suitable means of safety and, further, either the product could not perform its function if it were in compliance, or one or more requirements of the standard are inappropriate for the product.
In requesting a variance, a manufacturer should carefully follow the format for submission set forth in the regulations.138 Failure to provide all the required information may result in a delay in issuance of the variance; the variance is required before the product may be introduced into commerce. Exemptions from the standard and from the recordkeeping and reporting requirements have been granted to several Federal agencies, 1 39 including the Departments of Defense and Energy, some NASA facilities, and NOAA, for certain unique or classified products.
Manufacturers of certain specialized products may also be exempted from annual reporting and recordkeeping. і 40 Manufacturers who wish such an exemption should apply by submitting, with the Initial Report, justification and evidence showing that:
• the product cannot under any conditions emit levels of radiation that are hazardous; or
• the product is produced in such small numbers that the need for continuous reporting and recordkeeping is negated, and the product is to be used by individuals trained and knowledgeable in the hazards of such use.
The Director of CDRH may also exempt manufacturers from any part of the reporting and recordkeeping requirements if the exemption is judged to be in keeping with the purposes of the Act.
The US FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating radiation-emitting electronic products. Surgical dermatologic lasers, including laser and light-based (IPL) devices used for the cosmetic dermatology indication, fall under CDRH for marketing clearance. The CDRH is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Medical devices are classified into one of three classes: Class I, II, and III. Regulatory control and complexity increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
There of three generalized steps to obtaining Device Marketing Clearance from CDRH:
STEP ONE in the marketing process is to make absolutely sure that the product that you wish to market is a medical device, that is, does it meet the definition of a medical device in Section 201(h) of the FD&C Act. You also need to determine if the product may be an electronic radiation emitting product which has additional regulatory requirements.
STEP TWO is to determine how FDA may classify your device—which one of the three classes the device may fall into. Unless exempted, the FDA will classify your device based on its indication and market precedence. Classification identifies the level of regulatory control that is necessary to assure the safety and effectiveness of a medical device. Most important, the classification of the device will identify, unless exempt, the marketing process (either premarket notification [510(k)] or premarket approval (PMA)) the manufacturer must complete in order to obtain FDA clearance/approval for marketing.
STEP THREE is the development of data and/or information necessary to submit a marketing application, and to obtain FDA clearance to market. For some [510(k)] submissions and most PMA applications, clinical performance data is required to obtain clearance to market. In these cases, conduct of the trial must be done in accord with FDA’s Investigational Device Exemption regulation.
The medical device clearance/approval pathway is well-defined by the FDA. The FDA has also made a plethora of resources available to guide the medical-device development and submission process. The reader is encouraged to consult these resources and immerse themselves in the procedural process for medical devices before initiating the pursuit to commercialize a medical device. It is strongly recommended that individuals knowledgeable in successfully navigating the intricacies and nuances impacting medical device submissions be consulted to assist the sponsor in developing the strongest submission and maximize with optimizing the likelihood of achieving a favorable FDA clearance/approval.