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FDA Issues Guidance Documents on 510(k) Requirements for Changes to Medical Devices
October 24, 2017 |FDA

The Food and Drug Administration issued two guidance documents to clarify when a new 510(k) premarket submission is required when changes are made to existing medical devices. One new guidance document explains when software changes to existing devices require submission of a new 510(k). FDA also updated an existing guidance document on when other types of changes to existing devices require a new 510(k). The guidance documents are “not intended to implement significant policy changes to FDA’s current thinking on when submission of a new 510(k) is required” for changes to existing devices, the agency said. The guidance documents are instead intended to “enhance the predictability, consistency, and transparency of the 'when to submit' decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision, specifically as it relates to software changes,” it said.

FDA Posts New Timeline of Compliance Dates for FSMA Regulations, Including FSVP
October 24, 2017 |FDA

The Food and Drug Administration posted a new web page with a timeline of compliance dates for its Food Safety Modernization Act regulations. The agency also added a new graphical timeline for compliance dates under FSMA, including for human and animal food preventive regulations, produce safety regulations and the Foreign Supplier Verification Program. The next compliance date for FSMA is Jan. 26, when produce safety requirements take effect for small sprout farms and large farms of other produce.

FDA Releases Guidance Documents on FSMA Human and Animal Food Safety Rules
October 19, 2017 |FDA

The Food and Drug Administration on Oct. 19 released a pair of guidance documents intended to help human and animal food facilities comply with preventive controls regulations under the Food Safety Modernization Act, it said. A final guidance document explains current good manufacturing practice requirements for animal food, and includes a self-assessment tool facilities may use to evaluate their compliance. Another guidance document, in draft form, discusses the applicability of “solely engaged exemptions” from the preventive controls rules for human and animal foods, which may apply to holding or transportation of raw agricultural commodities, the storage of raw agricultural commodities (other than fruits and vegetables), the storage of unexposed packaged food, and other activities tied to the preparation of nuts and the ginning of cotton.