Food and Drug Administration

FDA Delays Post-market Safety Reporting Requirements for Combination Products

EMERGO SUMMARY OF KEY POINTS:

  • Postponed FDA enforcement of post-market safety reporting rules (PMSR) for combination products
  • Delay allows combination product applicants more time to implement appropriate reporting and recordkeeping systems and procedures

Five Reasons for Receiving an FDA Refuse-to-Accept (RTA) Decision on your 510(k) Registration

EMERGO SUMMARY OF KEY POINTS:

  • FDA 510(k) applicants may receive Refuse to Accept (RTA) letters if their submissions are not complete, delaying their medical device clearance reviews.
  • Meeting RTA screening criteria can help medical device registrants avoid receiving RTA letters from FDA reviewers.
  • Utilizing the FDA Pre-Submission (Pre-Sub) program prior to submitting 510(k) applications may also minimize the risk of clearance delays due to RTA issues.

Emergo Survey: Tempered Growth Expectations for Medical Device Markets in 2018

Medical device manufacturers’ growth expectations for markets worldwide have decreased for 2018 compared to previous years due to various regulatory and economic factors, a recent survey shows.

FDA: GUDID Data Primarily from Class II and Implantable Medical Devices (So Far)

EMERGO SUMMARY OF KEY POINTS:

  • The FDA GUDID database now has more than 1.6 million records of medical devices registered for sale in the US.
  • Most GUDID data is from Class II devices, and almost half of GUDID records cover implantable devices.
  • So far, orthopedic devices account for 35% of GUDID device records.

In Brief: US Legislators Put Medical Device Tax Back on Ice

US lawmakers have delayed reestablishing the Medical Device Excise Tax (MDET) by another two years as part of a short-term government funding arrangement.

US FDA Delays Contentious Medical Device Intended Use Rule

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has indefinitely delayed new requirements for evidence used to determine intended use.
  • The intended use-related requirements are part of a larger final rule covering tobacco products that fall under US medical device regulations.
  • The other parts of the final rule will go into effect in March 2018.

FDA Formalizes UDI Compliance Deadline Extension for Low-risk Devices

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has published guidance setting new UDI compliance deadlines for some Class I and unclassified medical devices.
  • The new deadlines were initially proposed in summer 2017.

US Regulators Refine Least Burdensome Provisions for Medical Device Oversight

EMERGO SUMMARY OF KEY POINTS:

  • US FDA has updated guidance on how least burdensome provisions are applied to medical device registration and oversight.
  • The new guidance applies across all aspects of FDA medical device regulation.
  • The FDA’s least burdensome approach may lead to less onerous US market authorization requirements for some manufacturers.

Final Guidance from US FDA on Clinical Evaluation of Software as a Medical Device (SaMD)

EMERGO SUMMARY OF KEY POINTS:

  • US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published.
  • The guidance utilizes SaMD clinical evaluation principles and recommendations issued by the International Medical Device Regulators Forum (IMDRF).
  • US regulators intend to use this guidance as a basis for developing more specific SaMD clinical evaluation guidance in the future.

US Regulators Lay Out Medical Device, IVD Guidance Priorities for 2018

EMERGO SUMMARY OF KEY POINTS:

  • The US FDA’s Center for Devices and Radiological Health (CDRH) unit has publicized plans for medical device and IVD guidances over the next year.
  • High-priority areas of focus for CDRH in 2018 include 510(k) third-party reviews and abbreviated pathways, Unique Device Identification (UDI) deadlines for low-risk devices and device accessory classification.
  • Not all planned CDRH guidance documents will be published due to resource allocation and other regulatory obligations.

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