FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications

Tommy McMaster |

FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications Key elements of this Guidance: - FDA has not changed the requirements, per say. They have split the requirements so there is clarity... Read more

A Critical Guidance Has Been Issued – “Refuse to “Accept Policy for 510(k)s”

Tommy McMaster |

Our very own Teresa Gorecki took to LinkedIn earlier this afternoon to announce... A critical Guidance has been issued by FDA; the new Guidance, “Refuse to “Accept Policy for 510(k)s”, is now available on fda.gov. This is an... Read more

New DRAFT FDA Guidance Published Today – Nonbinding Feedback

Tommy McMaster |

Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Limited to statutory (FDARA 704) situations involving a "public health priority", "implicat[ion] of systemic or major actions" or... Read more