Latest Federal Register Notices
DEVICES
FDA Guide on Medical Device Software
Federal Register Notice: FDA has made available a draft guidance on “Software as a Medical Device (SaMD): Clinical Evaluation.” The document was prepared under the auspices of the International Medical Device Regulators Forum, formerly the Global Harmonization Task Force. It focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. To view the guidance, click here. To view this notice, click here.
Rule Amends Definition of Custom Devices
Federal Register Final Rule: FDA has amended its regulations on the definition of a custom device to include new enumerated statutory requirements for such products. It amends the existing custom device exemption and introduces new concepts and procedures applicable to them. The amended definition states that a device will qualify as a custom device by meeting the following conditions: (1) Is created or modified in order to comply with the order of an individual physician or dentist (or other specially qualified person); (2) necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515 of the FD&C Act; (3) is not generally available in the U.S. in finished form; (4) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat; (5) either (a) is intended to meet the special needs of such physician or dentist in the course of the professional practice of such physician or dentist (or other specially qualified person as designated) in the course of their professional practice or (b) is intended for use by an individual patient named in the order of a physician or dentist (or other specially qualified person as designated); (6) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals, physician, or dentist; and (7) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. To view the rule, click here.
Guidance on Prescription-use Glucose Monitors
Federal Register Notice: FDA has made available a guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” The document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems which are for prescription point-of-care use in professional healthcare settings. To view the guidance, click here. To view this notice, click here.
OTC Blood Glucose Monitor Guidance
Federal Register Notice: FDA has made available a guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over- the-Counter Use.” The document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems intended for over-the-counter home use by lay-users. To view the guidance, click here. To view this notice, click here.
DRUGS
FDA Renews Dermatologic/Opthalmic Drugs Panel
Federal Register Notice: FDA has announced the renewal of the Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2018. To view this notice, click here.
FDA Renews Antimicrobial Drugs Panel
Federal Register Notice: FDA has renewed the Antimicrobial Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/7/2018. To view this notice, click here.
Guidance on Sunscreen Advisory Panel Process
Federal Register Notice: FDA has released a guidance on “Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process” for panels convened to determine whether a sunscreen active ingredient or combination of sunscreen active ingredients is generally recognized as safe and effective and should be added to the over-the-counter sunscreen drug monograph system. To view the guidance, click here. To view this notice, click here.
Guidance on Withdrawing Sunscreen Determination Requests
Federal Register Notice: FDA has made available a guidance on “Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.” The document provides recommendations for the process for withdrawing a 586A request submitted under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), and withdrawing a pending request, as defined by the SIA. Such requests and pending requests seek a determination from FDA of whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective and should be included in the over-the-counter sunscreen drug monograph. To view the guidance, click here. To view this notice, click here.