CDRH Updates Guidance on Refusing to Accept 510(k)s and PMAs

Regulatory NewsRegulatory News | 30 January 2018 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released updated guidance documents on its policies for refusing to accept 510(k)s and refusing to accept and file reviews for premarket approval applications (PMAs).

The PMA guidance supersedes a previous guidance from 31 December 2012, while the 510(k) guidance supersedes one with the same name from 4 August 2015.

The guidance documents feature checklists to identify necessary elements and contents of a complete application. The updates address provisions in the 21st Century Cures Act from 2016 as that law amended section 503(g) of the Food, Drug and Cosmetic Act (FD&C Act) and applies certain drug provisions to device-led combination products.

Under the amended section, submitters seeking action on a combination product must identify the product as such.

"Additionally, per the amended section 503(g)(5), submissions for device-led, device-drug combination products must include the patent certification or statement as described in section 505(b)(2) and provide notice as described in section 505(b)(3) if the combination product contains as a constituent part an approved drug," the guidances say.

FDA added in a statement: "If information regarding drug exclusivity or patents as outlined in these guidances is not included in a premarket submission received by FDA before or up to 60 days after publication, FDA intends to request such information during the review of the submission, as necessary."

On 20 March 2018, FDA will host a webinar for manufacturers and others about the statutory changes related to combination products included in these guidance documents.

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) Guidance for Industry and Food and Drug Administration Staff

Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff


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