After years of delays from various regulatory agencies, the US Food and Drug Administration (FDA) has announced the release of a major new proposed regulation on performance standards for laser products.

Background

FDA first proposed the rule in March 1999 before withdrawing it by November 1999. The rule was then resurrected in 2006 as part of FDA's unified agenda, a list of all documents it plans to publish in a given year.

The rule then languished further before being sent to the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs - an office that acts as a sort of regulator of regulators - on 24 May 2011. The rule remained at OIRA for an unusually lengthy amount of time, only reaching the public on 21 June 2013, more than two years after it was first submitted to OIRA and almost seven years after it was first proposed.

As explained by FDA, the proposal is meant to harmonize its laser requirements with those advanced by the International Electrotechnical Commission (IEC). The standard would apply to both normal laser products and medical laser products.

"The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science," FDA explained in an abstract for OIRA. "In addition, the proposal would include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products."

The problem, FDA explained in its Federal Register announcement on the regulation, is that at the time the last laser regulation was issued, many of the laser products that are now standard had yet to be invented. In the meantime, the IEC has continued to update its standards, and the scientific community's understanding of the risks associated with laser products has advanced as well.

The Rule

The practical effects of the rule could be mixed. A July 2001 guidance document noted that FDA would exercise its discretion in allowing companies to meet either FDA's or IEC's standards for laser products. The guidance was revised in 2007 to reference updated standards.

However, for those companies that have not yet met IEC's updated standards, FDA's proposed rule would finally require them to meet two IEC standards (IEC 60825-1:2007 and IEC 60601-2-22:2007) that have been slightly modified where FDA feels that "FDA's standard is more precise than the IEC's."

"For example, FDA's current standard with respect to collateral radiation, human access, modification of laser products, and key control capability protect against other hazards not reflected in the IEC standards. These differences relate specifically to the criteria in the IEC standards for determining human access to low levels of laser radiation that are recognized to be ocular hazards only, and concern the emission limits for surveying and visual display laser products."

However, the amount of time between the last laser products standard update - by FDA's count, around a quarter century - has necessitated certain structural changes as well. Regulators said the proposed standard would adopt many of IEC's concepts while retaining the "traditional organizational structure of the FDA standard" to aid with industry compliance.

Medical Products Provisions

The proposed rule contains provisions that are directly applicable to medical products.

Section 1040.11(a), explained FDA, would update certain clauses and sub-clauses to address updated technology and use conditions for medical laser products. These provisions (sub-clause 201.7.9.2 and clause 201.10) are meant to minimize exposure to laser radiation during use.

The complete substance of that rule is as follows:

• (a) Medical laser products. Each medical laser product must comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, such products must comply with the following specified clauses and subclauses of IEC 60601-2-22:2007 and IEC 60825-1:2007 (incorporated by reference; see § 1040.5).
  • (1) Instructions for use, subclause 201.7.9.2 of IEC 60601-2-22:2007
  • (2) Protection against unwanted and excessive radiation hazards, clause 201.10 of IEC 60601-2-22:2007, except for:
    • (i) Applicability to medical LED products, and
    • (ii) Emission indicator, subclause 201.10.4(e) of IEC 60601-2-22:2007, for which subclause 4.7 of IEC 60825-1:2007 is applicable
  • (3) Indication of laser output, subclause 201.12.1.101 of IEC 60601-2-22:2007
  • (4) Indication of parameters relevant to safety, subclause 201.12.4.2 of IEC 60601-2-22:2007
  • (5) Calibration procedures, subclause 201.7.9.2.101, 4th dash of IEC 60601-2-22:2007

Medical device manufacturers will also need to adhere to the rest of the standard, which includes requirements about warnings to be affixed on laser products, notes that light-emitting diodes (LEDs) are specifically exempt from the regulation, explains how the regulation applies to component parts, defines "collateral radiation," and includes engineering specifications.

Cost Considerations

FDA said that the costs of harmonizing certain products may be substantial for some manufacturers. "[Some] laser manufacturers would incur one-time additional costs from increased harmonization," estimated to be between six and seven million dollars. The benefits of the rule, estimated at $13.4 million, would outweigh those benefits, FDA said.

The agency's estimated economic costs may run into at least one problem, however. As most of the impact studies were conducted in 2006 when the rule was first being prepared, the agency said it has had to use inflation adjustments to account for some of the new estimates. This could give the industry an opportunity to argue that certain estimates are out of date, further delaying the rule.

FDA - Laser Products Rule