Regulatory Framework
Optos operates within a highly regulated environment, in the United States under the Food and Drug Administration’s Quality System Regulation (FDA 21CFR part 820) and the Safe Medical Devices Act of 1990. These provide the regulatory framework in the United States.
The Panoramic200 Scanning Laser Ophthalmoscope has clearance to market through Section 510(k) of the US Federal Food Drug & Cosmetic Act of 1938, as amended. This section of the Act governs the marketing of medical equipment that is substantially equivalent to established or predicate equipment. The company complies with current good manufacturing practice and meets the legislated safety and efficacy requirements. The European Economic Area (EEA) legislates through CE (Conformité Européene) marking to the Medical Device Directive (MDD-93/42/EEC). A notified body conducts a conformity assessment in support of CE marking. ISO13485:2003 is the international standard which provides the quality assurance framework and systems with which the company complies. Optos’ CE marking and Canadian Medical Device Establishment License is dependent on ISO13485:2003 accreditation. Optos is regularly audited against ISO13485:2003 and believes that it is fully compliant with its regulatory obligations and requirements.